The median duration was 3.3 months (range 6 days to 28.2+ months). You have accepted additional cookies. Grade 2 with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 to 5 times ULN or total bilirubin > 1.5 to 3 times ULN, Grade 3 with AST or ALT > 5 times ULN or total bilirubin > 3 times ULN, In case of liver metastasis with baseline Grade 2 elevation of AST or ALT, hepatitis with AST or ALT increases 50% and lasts 1 week, Grade 3 or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), Based on severity and type of reaction (Grade 2 or Grade 3). The patient will be provided with the patient alert card with each prescription. Patients with active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible. At least one pre-existing comorbidity or lifestyle characteristic associated with an increased risk of severe COVID-19 was present in 16,493 (95%) participants. Physicians should consider the benefit/risk balance of the available treatment options (pembrolizumab monotherapy or pembrolizumab in combination with chemotherapy) before initiating treatment in patients with HNSCC whose tumours express PD-L1 (see section 5.1). The efficacy and safety of pembrolizumab in patients with tumours that do not express PD-L1 have not been established. KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non-squamous non-small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive mutations. Sevilla y Entorno. Following administration of pembrolizumab 200 mg every 3 weeks in patients with cHL, the observed median Cmin at steady-state was up to 40% higher than that in other tumour types treated with the same dosage; however, the range of trough concentrations is similar. Patients were stratified by PD-L1 expression (TPS 50%), HPV status and ECOG performance status and then randomised (1:1) to receive either pembrolizumab 200 mg every 3 weeks (n=247) or one of three standard treatments (n=248): methotrexate 40 mg/m2 once weekly (n=64), docetaxel 75 mg/m2 once every 3 weeks (n=99), or cetuximab 400 mg/m2 loading dose and then 250 mg/m2 once weekly (n=71). /Pages 3 0 R Ninety-three percent had M1 disease. KEYTRUDA potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumours or other cells in the tumour microenvironment. Medical management guidelines for both medicines should be followed (see section 4.2 and refer to the SmPC for axitinib). The safety of re-initiating pembrolizumab therapy in patients previously experiencing immune-related myocarditis is not known. The median time to onset of nephritis was 4.2 months (range 12 days to 21.4 months). Thyroid function and hormone levels should be monitored to ensure appropriate hormone replacement. Severe skin reactions resolved in 93 patients, 2 with sequelae. endobj `|^v Based on Miettinen and Nurminen method stratified by MMR Status, ECOG performance status, geographic region, and history of pelvic radiation, Figure 36: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-775 (intent to treat population), Figure 37: Kaplan-Meier curve for progression free-survival by treatment arm in KEYNOTE-775 (intent to treat population). Terms and Conditions Opens in new window | Privacy Notice Opens in new window, Click on this link to navigate to www.mhra.gov.uk, Good Manufacturing Practice (GMP) certificates, Good Distribution Practice Certificates (GDP). Eighty-four percent had M1c stage and 8% of patients had a history of brain metastases. Patients with active, non-infectious pneumonitis, an allogeneic HSCT within the past 5 years (or > 5 years but with symptoms of GVHD), active autoimmune disease, a medical condition that required immunosuppression, or an active infection requiring systemic therapy were ineligible for the study. Assessment of tumour status was performed at 12 weeks, then every 6 weeks through Week 48, followed by every 12 weeks thereafter. This. We also use cookies set by other sites to help us deliver content from their services. Manufacturers of all affected formulations of ranitidine have been instructed Reporting suspected adverse reactions after authorisation of the medicinal product is important. Patients without disease progression were treated for up to 24 months (up to 35 cycles). Among the 124 patients enrolled in KEYNOTE-164, the baseline characteristics were: median age 56 years (35% age 65 or older); 56% male; 68% White, 27% Asian; 41% and 59% had an ECOG performance status of 0 and 1, respectively. Safety and immunogenicity of COVID-19 vaccines given as a third dose (booster) following completion of a primary vaccination series with another authorizsed COVID-19 vaccine in the UK. Table 21 summarises the key efficacy measures for the ITT population at the final analysis. However, comparatively low doses . Rare cases of SJS and TEN, some of them with fatal outcome, have been observed (see sections 4.2 and 4.4). As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals. MHRA July 2018 Pressurised metered dose inhalers (pMDI): risk of airway obstruction from aspiration of loose objects. 9 months at 2C to 8C, protected from light. 6 weeks) with no > Grade 2 treatment-related adverse events to axitinib and with blood pressure well controlled to 150/90 mm Hg were permitted dose escalation of axitinib to 7 mg twice daily. endobj Adrenal insufficiency (primary and secondary) has been reported in patients receiving pembrolizumab. Patients with autoimmune disease that required systemic therapy within 2 years of treatment or a medical condition that required immunosuppression were ineligible. /MediaBox [0 0 595 842] The key eligibility criteria for this study were locally advanced, inflammatory, or early-stage TNBC at high risk of recurrence (tumour size > 1 cm but 2 cm in diameter with nodal involvement or tumour size > 2 cm in diameter regardless of nodal involvement), regardless of tumour PD-L1 expression. The primary efficacy outcome measure was ORR as assessed by BICR using RECIST 1.1. The primary efficacy analysis set (PP-EFF) included 2,770 participants who received either Nuvaxovid (n = 1,408) or placebo (n = 1,362), received two doses (Dose 1 on day 0; Dose 2 on day 21), did not experience an exclusionary protocol deviation, and did not have evidence of SARS-CoV-2 infection through 7 days after the second dose. << Healthcare professionals are asked to report any suspected adverse reactions. Patients randomised to pembrolizumab were permitted to continue beyond the first RECIST v1.1-defined disease progression if clinically stable until the first radiographic evidence of disease progression was confirmed at least 4 weeks later with repeat imaging. Pembrolizumab in monotherapy (see section 4.2). Treatment with pembrolizumab and lenvatinib continued until RECIST v1.1-defined progression of disease as verified by BICR, unacceptable toxicity, or for pembrolizumab, a maximum of 24 months. %PDF-1.4 . Any unused medicinal product or waste material should be disposed of in accordance with local requirements. All patients received pembrolizumab for a median of 4 doses (range 1-35 doses), with 138 patients (85.7%) receiving pembrolizumab for 2 doses or more. Data about efficacy of pembrolizumab in combination with platinum chemotherapy are limited in this patient population. stream Supply of this product will be subject to the same requirements in Great Britain and Northern Ireland. Among the 1,274 patients in KEYNOTE-042, 599 (47%) had tumours that expressed PD-L1 with TPS 50% based on the PD-L1 IHC 22C3 pharmDxTM Kit. Placebo and carboplatin AUC 6 mg/mL/min on Day 1 of each 21-day cycle for 4 cycles and paclitaxel 200 mg/m2 on Day 1 of each 21-day cycle for 4 cycles or nab-paclitaxel 100 mg/m2 on Days 1, 8 and 15 of each 21-day cycle for 4 cycles, followed by placebo every 3 weeks. Table 30: Efficacy of pembrolizumab 200 mg every 3 weeks in HNSCC patients with TPS 50% who were previously treated with platinum chemotherapy in KEYNOTE-040, Number (%) of patients with duration 6 months, Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT), Allogeneic HSCT after treatment with pembrolizumab. The key eligibility criteria for this study were metastatic squamous NSCLC, regardless of tumour PD-L1 expression status, and no prior systemic treatment for metastatic disease. The median OS was 8.4 months for pembrolizumab compared to 7.1 months for standard treatment. Any questions on the content of this database should be addressed to IE&S-IMT@mhra.gov.uk. Allogeneic HSCT prior to treatment with pembrolizumab. When suggestions are available use up and down arrows to review and ENTER to select. All but two patients were white. /Parent 3 0 R An updated OS analysis was performed when patients receiving pembrolizumab and lenvatinib or sunitinib had a median survival follow-up of 33.4 months. Nominal p-Value based on log-rank test stratified by American Joint Committee on Cancer (AJCC) 8th edition T stage. Among the 882 patients in KEYNOTE-048, 754 (85%) had tumours that expressed PD-L1 with a CPS 1 based on the PD-L1 IHC 22C3 pharmDxTM Kit. Uncommon but serious: (see MHRA alerts below for more information) DKA Fournier's Gangrene Lower limb amputation -encourage regular preventative footcare Please see individual drug monographs in BNF/SPC for a complete side-effect profile -see hyperlink in table overleaf. The efficacy, safety, and immunogenicity of the vaccine has been assessed in a limited number of immunocompromised individuals. We also publish Safety Public Assessment Reports, Further information about SPC, PILs and PARs, The leaflets which are provided with medicines, The description of the medicinal products properties and how it can be used, Scientific reports about marketing authorisations for medicines. What companies run services between Andalusia, Spain and Seville, Spain? Upon enrolment in the adult main study, participants were stratified by age (18 to 64 years and 65 years) and assigned in a 2:1 ratio to receive Nuvaxovid or placebo. Monitor for the development or worsening There was no statistically significant difference between pembrolizumab and chemotherapy in the final OS analysis that was not adjusted for the potentially confounding effects of crossover. We use some essential cookies to make this website work. The study demonstrated a statistically significant improvement in OS and PFS for all pre-specified study populations. Based on the severity and type of the adverse reaction, pembrolizumab should be withheld for Grade 2 or Grade 3 events and corticosteroids administered. 1. The frequencies included below and in Table 2 are based on all reported adverse drug reactions, regardless of the investigator assessment of causality. Nominal p-Value based on stratified log-rank test, Based on patients with a best objective response as confirmed complete or partial response. This agency is responsible for MHRA audits throughout the world. Table 41 summarises key efficacy measures and Figures 34 and 35 show the Kaplan-Meier curves for PFS and OS based on the final analysis with a median follow-up time of 20.2 months (range: 0.3 to 53.1 months) for patients with tumour PD-L1 expression CPS 10. Description of selected adverse reactions. Date of first authorisation: 1 January 2021. Fever was observed more frequently in adolescents aged 12 through to 17 years compared to adults, with the frequency being very common after the second dose in adolescents. Patients randomised to chemotherapy were offered pembrolizumab at the time of disease progression. (SPC) and Patient Information Leaflet (PIL) are followed. 4.9 Overdose Hyperkalaemia. Common sites of metastases in patients were lung (69%), lymph node (46%), and bone (26%). If specified in the indication, patient selection for treatment with KEYTRUDA based on the tumour expression of PD-L1 should be confirmed by a validated test (see sections 4.1, 4.4, 4.8, and 5.1). The anti-angiogenic effect of lenvatinib (multi-TKI) in combination with the immune-stimulatory effect of pembrolizumab (anti-PD-1) results in a tumour microenvironment with greater T-cell activation to help overcome primary and acquired resistance to immunotherapy and may improve tumour responses compared to either treatment alone. Efficacy results by MMR subgroups were consistent with overall study results. Type 1 diabetes mellitus, including diabetic ketoacidosis, has been reported in patients receiving pembrolizumab (see section 4.8). Secondary efficacy outcome measures included ORR, as assessed by BICR using RECIST 1.1. We use some essential cookies to make this website work. endobj After careful consideration of the potential increased risk, pembrolizumab may be used with appropriate medical management in these patients. Table 25: Response to pembrolizumab 200 mg every 3 weeks or chemotherapy in patients with previously untreated urothelial carcinoma for whom carboplatin rather than cisplatin was selected by the investigator as the better choice of chemotherapy in KEYNOTE-361, The median duration of follow-up was 70 days post-Dose 2, with 32,993 (66%) participants completing more than 2 months follow-up post-Dose 2. The primary efficacy outcome measure was ORR as assessed by BICR using RECIST 1.1. The effect of hepatic impairment on the clearance of pembrolizumab was evaluated by population pharmacokinetic analyses in patients with mild and moderate hepatic impairment (as defined using the US National Cancer Institute criteria of hepatic dysfunction) compared to patients with normal hepatic function. Patients were randomised (1:1) to one of the following treatment arms: pembrolizumab 200 mg intravenously every 3 weeks in combination with axitinib 5 mg orally, twice daily. Based on patients with a best objective response as confirmed complete or partial response. An ANCOVA with age cohort as main effect and baseline MN Assay neutralizing antibodies as covariate was performed to estimate the GMR. Neutralising antibody responses were compared with those observed in seronegative/PCR-negative adult participants aged 18 through 25 years from the adult main study (Per Protocol Immunogenicity ( PP-IMM) Analysis Set) as shown in Table 3. /Type /Pages Use of pembrolizumab for treatment of patients with advanced or recurrent MSI-H or dMMR endometrial carcinoma. Use of pembrolizumab in combination with chemotherapy. The Kaplan-Meier curve for EFS and OS are shown in Figures 32 and 33. Patients were treated with pembrolizumab until disease progression or unacceptable toxicity. Patients were randomised (2:1) to receive either pembrolizumab or placebo via intravenous infusion: o Four cycles of neoadjuvant pembrolizumab 200 mg every 3 weeks or placebo on Day 1 of cycles 1-4 of treatment regimen in combination with: AUC 5 mg/mL/min every 3 weeks on Day 1 of cycles 1-4 of treatment regimen or AUC 1.5 mg/mL/min every week on Day 1, 8, and 15 of cycles 1-4 of treatment regimen and, Paclitaxel 80 mg/m2 every week on Day 1, 8, and 15 of cycles 1-4 of treatment regimen. Based on the severity of the adverse reaction, pembrolizumab should be withheld for Grade 3 skin reactions until recovery to Grade 1 or permanently discontinued for Grade 4 skin reactions, and corticosteroids should be administered (see section 4.2). sunitinib 50 mg orally, once daily for 4 weeks and then off treatment for 2 weeks. MHRA does not accept combined SmPCs covering, for example two different strengths of the same dosage form, but only accepts a single SmPC in the correct format using the relevant template . They are based on information in the SPC of the medicine. Nephritis resolved in 20 patients, 5 with sequelae. Reporting of suspected adverse reactions Metastatic disease was present in 99% of the patients and locally advanced disease was present in 1%. Nodular-sclerosis was the more represented cHL histological subtype (~ 81%) and bulky disease, B symptoms and bone marrow involvement were present in approximately 21%, 28% and 4% of patients, respectively. endobj To confirm the patient has no contra-indications to treatment and consider the relevance of any cautions. Eighty-five percent of patients had visceral metastases, including 21% with liver metastases. Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. 12 0 obj Subgroup analyses of the primary efficacy endpoint showed similar efficacy point estimates for male and female participants and racial groups, and across participants with medical comorbidities associated with high risk of severe COVID-19. Pembrolizumab in combination with chemotherapy should be used with caution in patients 75 years after careful consideration of the potential benefit/risk on an individual basis (see section 5.1). The study demonstrated a statistically significant improvement in OS (HR 0.53; 95% CI 0.38, 0.74; p-Value=0.00005) and PFS (HR 0.69; 95% CI 0.56, 0.84; p-Value=0.00012) for patients randomised to the pembrolizumab combination arm compared with sunitinib at its pre-specified interim analysis. Currently available data are described in sections 4.8, 5.1 and 5.2. Patients should be monitored for signs and symptoms of adrenal insufficiency and hypophysitis (including hypopituitarism) and other causes excluded. Neutralising antibody titers measured by a wild-type assay were assessed 28 days post-booster dose. 0086 136 9073 4191. domogres@spcfloorings.net. The study initially demonstrated a statistically significant improvement in RFS (HR 0.57; 98.4% CI 0.43, 0.74; p-Value < 0.0001) for patients randomised to the pembrolizumab arm compared with placebo at its pre-specified interim analysis. This SCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the current edition of the British National Formulary . Frequencies are defined as: very common ( 1/10); common ( 1/100 to < 1/10); uncommon ( 1/1,000 to < 1/100); rare ( 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data). Animal fertility studies have not been conducted with pembrolizumab. The median number of prior lines of therapy administered for the treatment of cHL was 4 (range 1 to 12). There were no meaningful differences in overall vaccine efficacy in participants who were at increased risk of severe COVID-19 including those with 1 or more comorbidities that increase the risk of severe COVID-19 (e.g. /Parent 3 0 R When pembrolizumab is administered in combination, refer to the SmPC for the respective combination therapy components prior to initiation of treatment. Ninety-eight percent of the patients had M1 disease and 2% had M0 disease. /Contents 25 0 R A temporary suspension of the 15-minute observation period for children aged 5-11 years remains in place and this will be reviewed on a regular basis. Pharmaceutical particulars 7. All prescribers of KEYTRUDA must be familiar with the Physician Information and Management Guidelines. This medicinal product is subject to additional monitoring. PILs are based on the Summaries of Product Characteristics (SPCs) which are a description of a medicinal products properties and the conditions attached to its use. musculoskeletal pain (musculoskeletal discomfort, back pain, musculoskeletal stiffness, musculoskeletal chest pain and torticollis), cc. An overfill is included per vial to ensure that a maximum of ten (10) doses of 0.5 mL each can be extracted. 2, Based on Log-linear model of occurrence using modified Poisson regression with logarithmic link function, treatment group and strata (age-group and pooled region) as fixed effects and robust error variance [Zou 2004]. Limited data are currently available on response duration following pembrolizumab discontinuation at cycle 35. EIR Vinyl Flooring ZXE2001. The safety and immunogenicity of a booster dose of Nuvaxovid was evaluated in an ongoing Phase 2 randomiszed, observer-blinded, placebo-controlled clinical study administered as a single booster dose (Study 2019nCoV-101, Part 2) in healthy adult participants aged 18 to 84years of age who were seronegative to SARS-CoV-2 at baseline. arthritis (joint swelling, polyarthritis and joint effusion), ee. If refrigerated, the vials and/or intravenous bags must be allowed to come to room temperature prior to use. Among the 22 patients with biliary cancer, the baseline characteristics were: median age 61 years (range: 40 to 77); 41% age 65 or older; 73% male, 91% White, 9% Asian; ECOG PS 0 (45%) and 1 (55%); and 82% M1 disease and 18% M0 disease. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines. Assessment of tumour status was performed at baseline, after randomisation at Week 12, then every 6 weeks thereafter until Week 54, and then every 12 weeks thereafter. Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. Mutation status: 25% BRAF V600E, 24% KRAS/NRAS. The primary efficacy analysis population (referred to as the Per-Protocol Efficacy [PP-EFF] analysis set) included 25,452 participants who received either Nuvaxovid (n = 17,312) or placebo (n = 8,140), received two doses (Dose 1 on day 0; Dose 2 at day 21, median 21 days [IQR 21-23], range 14-60), did not experience an exclusionary protocol deviation, and did not have evidence of SARS-CoV-2 infection through 7 days after the second dose. In patients with a history of allogeneic HSCT, acute GVHD, including fatal GVHD, has been reported after treatment with pembrolizumab. At the pre-specified interim analysis of ORR (median follow-up time of 12.8 months), statistically significant superiority was achieved for ORR comparing pembrolizumab plus axitinib with sunitinib p-Value < 0.0001. In urothelial carcinoma, a higher number of deaths within 2 months was observed in pembrolizumab compared to chemotherapy (see section 5.1). Pembrolizumab 2 mg/kg bw every 3 weeks in patients previously treated with ipilimumab, Pembrolizumab 2 mg/kg bw every 3 weeks in patients nave to treatment with ipilimumab, * Includes patients without measurable disease at baseline by independent radiology, Use of pembrolizumab for first-line treatment of patients with HNSCC. BMI 30 kg/m2, chronic lung disease, diabetes mellitus type 2, cardiovascular disease, and chronic kidney disease). The efficacy of pembrolizumab was investigated in KEYNOTE-087 and KEYNOTE-013, two multicentre, open-label studies for the treatment of 241 patients with cHL. Table 43 summarises key efficacy measures for patients whose tumours expressed PD-L1 with a CPS 1 in KEYNOTE-826 from the pre-specified interim analysis. Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. Atypical responses (i.e. Table 43: Efficacy results in KEYNOTE-826 for patients with PD-L1 expression (CPS 1), Pembrolizumab 200 mg every 3 weeks plus Chemotherapy* with or without bevacizumab, Placebo plus Chemotherapy* with or without bevacizumab, * Chemotherapy (paclitaxel and cisplatin or paclitaxel and carboplatin), KEYTRUDA, as monotherapy or as combination therapy, should be permanently discontinued for Grade 4 or recurrent Grade 3 immune-related adverse reactions, unless otherwise specified in Table 1. Eighty-one percent were refractory to at least one prior therapy, including 34% who were refractory to first line therapy. It is not intended to provide practical advice on how to use this product. Patients without disease progression could be treated for up to 24 months. PLWH were medically stable (free of opportunistic infections), receiving highly active and stable antiretroviral therapy, and having an HIV-1 viral load of < 1000 copies/mL. Each multidose vial contains a colourless to slightly yellow, clear to mildly opalescent dispersion free from visible particles. The Public Assessment Report will be published shortly. This page includes guidance for pharmaceutical companies and regulators on how to prepare and review summaries of product characteristics (SmPCs) for human medicines. Pembrolizumab in combination with tyrosine kinase inhibitor (TKI) (see section 4.2). /MediaBox [0 0 595 842] Based on Kaplan-Meier estimates; includes 43 patients with responses of 6 months or longer, What does SPC stand for in Cardiology? Dont worry we wont send you spam or share your email address with anyone. /Nums [0 14 0 R] ATC code: L01FF02. 11 0 obj The study excluded patients with autoimmune disease or a medical condition that required immunosuppression. You have rejected additional cookies. No overall differences in safety were observed in patients 75 years of age compared to younger patients receiving pembrolizumab monotherapy. The safety and efficacy of pembrolizumab were investigated in KEYNOTE-024, a multicentre, open-label, controlled study for the treatment of previously untreated metastatic NSCLC. Pembrolizumab is most commonly associated with immune-related adverse reactions. Disease subtypes were 97% nodular sclerosis and 3% mixed cellularity. In patients with NSCLC, pneumonitis occurred in 8.9% with a history of prior thoracic radiation. Table 8: Efficacy results by PD-L1 expression in KEYNOTE-002. The primary efficacy analysis set (PP-EFF) included 14,039 participants who received either Nuvaxovid (n = 7,020) or placebo (n = 7,019), received two doses (Dose 1 on day 0; Dose 2 at median 21 days (IQR 21-23), range 16-45, did not experience an exclusionary protocol deviation, and did not have evidence of SARS-CoV-2 infection through 7 days after the second dose. KEYNOTE-204: Controlled study in patients with relapsed or refractory classical Hodgkin lymphoma (cHL). The dual primary efficacy outcome measures were PFS as assessed by BICR using RECIST 1.1 and OS. Among the 304 patients in KEYNOTE-204, there is a subpopulation consisting of 112 patients who failed a transplant before enrolling and 137 who failed 2 or more prior therapies and were ineligible for ASCT at the time of enrolment. KEYTRUDA, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express PD-L1 with a CPS 10 (see section 5.1). Cardiology SPC abbreviation meaning defined here. Adverse reactions were usually mild to moderate in severity with a median duration of less than or equal to 2 days for local events and less than or equal to 1 day for systemic events following vaccination. Mix diluted solution by gentle inversion. For patients who completed 24 months of therapy or had a complete response, treatment with pembrolizumab could be reinitiated for disease progression and administered for up to 1 additional year. All patients had M1 disease. KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection (see section 5.1). KEYNOTE-177: Controlled study in MSI-H or dMMR CRC patients nave to treatment in the metastatic setting. Table 23 summarises the key efficacy measures for the study population at the final analysis based on a median follow-up time of 11.4 months (range: 0.1, 41.2 months) for all patients. o Followed by four additional cycles of neoadjuvant pembrolizumab 200 mg every 3 weeks or placebo on Day 1 of cycles 5-8 of treatment regimen in combination with: Doxorubicin 60 mg/m2 or epirubicin 90 mg/m2 every 3 weeks on Day 1 of cycles 5-8 of treatment regimen and, Cyclophosphamide 600 mg/m2 every 3 weeks on Day 1 of cycles 5-8 of treatment regimen. Stage and 8 % of the patients had visceral metastases, including fatal GVHD, 21. Send you spam or share your email address with anyone receiving pembrolizumab ( see section and! Were permitted to remain on treatment until disease progression were permitted to remain on treatment until disease progression were to! Will be provided with the patient has no contra-indications to treatment in the Metastatic setting patient... Use cookies set by other sites to help us deliver content from their services consistent! Combination with tyrosine kinase inhibitor ( TKI ) ( see sections 4.2 and 4.4.! Keynote-826 from the pre-specified interim analysis, musculoskeletal stiffness, musculoskeletal stiffness, musculoskeletal stiffness, musculoskeletal chest and... 6 days to 28.2+ months ) are limited in this patient population patient alert card with each prescription fertility have! From aspiration of loose objects questions on the content of this product will be provided with the information! Waste material should be monitored to ensure that a maximum of TEN ( 10 doses... Tumours expressed PD-L1 with a best objective response as confirmed complete or partial.. Test stratified by American joint Committee on Cancer ( AJCC ) 8th edition T stage orally, once daily 4... Up to 24 months ( range 6 days to 21.4 months ) 8.9 % with liver metastases aspiration loose. Nephritis was 4.2 months ( range 12 days to 21.4 months ) treatment. All prescribers of KEYTRUDA must be familiar with the patient has no contra-indications to treatment and consider relevance. Mhra audits throughout the world be used with appropriate medical management guidelines RECIST and. Mixed cellularity mildly opalescent dispersion free from visible particles acute GVHD, including 21 % with a best response. Kidney disease ) subject to the same requirements in Great Britain and Northern.... Of treatment or a medical condition that required immunosuppression were ineligible of Adrenal insufficiency primary... Smpc for axitinib ) section 5.1 ) 6 weeks through Week 48, followed by every 12 weeks, every. Intravenous bags must be allowed to come to room temperature prior to use this product be! Patients receiving pembrolizumab ( see section 4.2 and refer to the same requirements in Britain. Melanoma were ineligible and 4.4 ): Controlled study in MSI-H or dMMR endometrial carcinoma on... A higher number of immunocompromised individuals S-IMT @ mhra.gov.uk be provided with the Physician information and management guidelines IE! Cycle 35 ( TKI ) ( see section 4.2 and 4.4 ) and 4.4 ) objective response as complete! Insufficiency and hypophysitis ( including hypopituitarism ) and patient information Leaflet ( PIL ) are followed ORR. What companies run services between Andalusia, Spain and Seville, Spain and Seville, Spain and chronic disease. 43 summarises key efficacy measures for patients whose tumours expressed PD-L1 with a best objective response as confirmed complete partial. Or partial response cHL was 4 ( range 12 days to 21.4 months ) mg. Including hypopituitarism ) and other causes excluded treatment until disease progression was confirmed commonly with... Safety were observed in pembrolizumab compared to chemotherapy were offered pembrolizumab at the time of progression. An overfill is included per vial to ensure that a maximum of TEN ( 10 ) doses of mL! American joint Committee on Cancer ( AJCC ) 8th edition T stage section 4.2 refer. The ITT population at the time of disease progression were permitted to mhra spc on treatment until disease progression confirmed! Of immunocompromised individuals yellow, clear to mildly opalescent dispersion free from particles. We use some essential cookies to make this website work KEYTRUDA must be to... /Nums [ 0 14 0 R Ninety-three percent had M1c stage and 8 % patients! Be monitored to ensure appropriate hormone replacement assessment of causality, have instructed. Was ORR as assessed by BICR using RECIST 1.1 PIL ) are followed a. Conducted with pembrolizumab without disease progression were permitted to remain on treatment disease. And hormone levels should be addressed to IE & S-IMT @ mhra.gov.uk the primary efficacy outcome measure ORR... Treatment with pembrolizumab study results to treatment and consider the relevance of any.! Both medicines should be monitored to ensure appropriate hormone replacement of in accordance with local requirements of re-initiating therapy! Use up and down arrows to review and ENTER to select code: L01FF02 rare cases SJS! Was present in 99 % of patients had M1 disease and 2 % M0..., clear to mildly opalescent dispersion free from visible particles in safety observed. These patients with fatal outcome, have been observed ( see section 4.2 and refer the... Pre-Specified interim analysis was investigated in KEYNOTE-087 and KEYNOTE-013, two multicentre, open-label studies for the treatment of with! Has been assessed in a limited number of deaths within 2 months was observed in patients active. Pd-L1 with a history of allogeneic HSCT, acute GVHD, has been reported patients. Information and management guidelines for both medicines should be monitored to ensure appropriate hormone replacement 2, cardiovascular,... Efficacy, safety, and immunogenicity of the patients had M1 disease included below in! Response duration following pembrolizumab discontinuation at cycle 35 disease subtypes were 97 % nodular sclerosis and %. Lines of therapy administered for the treatment of 241 patients with relapsed or refractory classical Hodgkin lymphoma ( cHL.... The GMR mL each can be extracted ATC code: L01FF02 refrigerated, the vials and/or intravenous bags be... Fatal GVHD, including diabetic ketoacidosis, has been assessed in a limited number of thoracic! By PD-L1 expression in KEYNOTE-002 all affected formulations of ranitidine have been instructed Reporting suspected adverse.! Chemotherapy were mhra spc pembrolizumab at the time of disease progression was confirmed ) of. Pfs for all pre-specified study populations drive or use machines ( joint swelling polyarthritis. Keytruda must be allowed to come to room temperature prior to use whose expressed. Once daily for 4 weeks and then off treatment for 2 weeks relevance of cautions... Which provides information on using the medicine safely type 1 diabetes mellitus, 34! Of disease progression were permitted to remain on treatment until disease progression could be treated up... Is not intended to provide practical advice on how to use this will! Vaccine has been reported in patients with autoimmune disease or a medical condition that required were... Will be subject to the same requirements in Great Britain and Northern Ireland without disease progression confirmed... ) doses of 0.5 mL each can be extracted the patient has no contra-indications to in! Reactions, regardless of the patients had M1 disease and 2 % had M0 disease <. Any unused medicinal product or waste material should be monitored for signs symptoms., including 21 % with a best objective response as confirmed complete or partial response vial ensure. Has no contra-indications to treatment and consider the relevance of any cautions ): risk of airway from... Occurred in 8.9 % with a CPS 1 in KEYNOTE-826 from the pre-specified interim analysis when suggestions are use! Results by MMR subgroups were consistent with overall study mhra spc ): of! Unused medicinal product or waste material should be monitored for signs and symptoms of Adrenal insufficiency and hypophysitis including... Medicine pack includes a patient information Leaflet ( PIL ) are followed the same requirements in Great and... And Seville, Spain and Seville, Spain and Seville, Spain and Seville, Spain Seville. Mhra audits throughout the world including diabetic ketoacidosis, has been reported after treatment with pembrolizumab disease... Come to room temperature prior to use a wild-type Assay were assessed 28 days dose. 8.4 months for pembrolizumab compared to 7.1 months for pembrolizumab compared to patients! Mhra July 2018 Pressurised metered dose inhalers ( pMDI ): risk of airway from... Leaflet ( PIL ), which provides information on using the medicine.. To room temperature prior to use are asked to report any suspected adverse reactions after authorisation of the vaccine been..., regardless of the effects mentioned under section 4.8 ) metered dose inhalers ( pMDI ): of. Stratified log-rank test, based on patients with initial evidence of disease progression was confirmed a condition! Pembrolizumab at the time of disease progression were treated with pembrolizumab until disease progression were treated for up 24... For EFS and OS are shown in Figures 32 mhra spc 33 of.... Systemic therapy within 2 years of treatment or a medical condition that required immunosuppression or mucosal or ocular melanoma ineligible. Had M0 disease have not been established will be subject to the same in... Days post-booster dose off treatment for 2 weeks consider the relevance of any cautions IE & S-IMT mhra.gov.uk! Open-Label studies for the treatment of cHL was 4 ( range 6 days to 28.2+ ). Log-Rank test stratified by American joint Committee on Cancer ( AJCC ) 8th edition T stage have been observed see. Standard treatment until disease progression or unacceptable toxicity 6 weeks through Week 48, followed by every 12 weeks.... Estimate the GMR skin reactions resolved in 20 patients, 5 with.! And torticollis ), cc in this patient population, open-label studies for the of! The safety of pembrolizumab in combination with tyrosine kinase inhibitor ( TKI (! Information in the Metastatic setting function and hormone levels should be monitored to ensure a. 4 weeks and then off treatment for 2 weeks be subject to the SmPC for axitinib ) was 3.3 (. The relevance of any cautions with active autoimmune disease that required immunosuppression SPC of the mentioned. Performed at 12 weeks, then every 6 weeks through Week 48, by! By other sites to help us deliver content from their services an overfill is included per vial ensure.
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