mhra spcmhra spc

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. /Resources 16 0 R Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of pembrolizumab (see Description of selected adverse reactions below). All participants were offered the opportunity to continue to be followed in the study. The baseline characteristics for this population included: median age 63 years (42% age 65 or older); 61% male; 72% White and 21% Asian and 34% and 66% with an ECOG performance status 0 and 1, respectively. The median duration of treatment for pembrolizumab plus lenvatinib was 17.0 months. /Type /Page Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. The primary efficacy outcome was PFS and the secondary efficacy outcome measure was ORR, both assessed by BICR according to the 2007 revised International Working Group (IWG) criteria. Information on the original Spikevax COVID-19 vaccine can found on a separate page (link below). You have rejected additional cookies. The MHRA products website allows you to find: The leaflets which are provided with medicines The description of the medicinal product's properties and how it can be used Scientific reports about. Close observation for at least 15 minutes is recommended following vaccination. either cisplatin or carboplatin with gemcitabine) versus chemotherapy as first-line treatment in subjects with advanced or metastatic urothelial carcinoma. 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. >> SPC Flooring. Assessment of tumour status was performed at baseline and then every 8 weeks. Assessment of tumour status was performed every 9 weeks through the first year, then every 12 weeks thereafter. 2. The median time to onset of severe skin reactions was 3.0 months (range 2 days to 25.5 months). Storage at 25C is not the recommended storage or shipping condition but may guide decisions for use in case of temporary temperature excursions during the 9-month storage at 2C to 8C. In the per-protocol immunogenicity (PP-IMM) analysis set for participants who received Nuvaxovid (n = 191), median age was 40 years (range: 22 to 70 years); 93% (n = 178) were 18 to 64 years old and 7% (n = 13) were aged 65 to 84; 43% were female; 75% were White; 23% were multiracial or from ethnic minorities; and 27% had at least one comorbid condition. Treatment with pembrolizumab continued until RECIST 1.1-defined progression of disease as determined by the investigator, unacceptable toxicity, or a maximum of 24 months. Among patients with BRAF mutant tumours, 139 (46%) were previously treated with a BRAF inhibitor. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk. Disease characteristics were squamous (18%) and non-squamous (82%); M1 (99%); and brain metastases (9%). Patients should be monitored for changes in thyroid function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and clinical signs and symptoms of thyroid disorders. No dose adjustment is necessary in patients 65 years (see sections 4.4 and 5.1). Table 9: Efficacy results by PD-L1 expression in KEYNOTE-006. Incidences of Grades 3-5 adverse reactions in patients with NSCLC were 67% for pembrolizumab combination therapy and 66% for chemotherapy alone, in patients with HNSCC were 85% for pembrolizumab combination therapy and 84% for chemotherapy plus cetuximab, in patients with oesophageal carcinoma were 86% for pembrolizumab combination therapy and 83% for chemotherapy alone, in patients with TNBC were 80% for pembrolizumab combination therapy and 77% for chemotherapy alone, and in patients with cervical cancer were 82% for pembrolizumab combination and 75% for chemotherapy alone. A direct comparison of pembrolizumab when used in combination with chemotherapy to pembrolizumab monotherapy is not available. Jevany, 28163 It is unknown whether pembrolizumab is secreted in human milk. /Parent 3 0 R Seventy-four percent of patients had received ASCT, 26% were transplant ineligible, and 45% of patients had prior radiation therapy. The dispersion is colourless to slightly yellow, clear to mildly opalescent (pH 7.2). An analysis of the SARS-CoV-2 neutralising antibody response 14 days after Dose 2 (Day 35) was conducted in adolescent participants seronegative to anti-SARS-CoV-2 nucleoprotein (NP) and PCR-negative at baseline. Patients on chemotherapy who experienced independently-verified progression of disease after the first scheduled disease assessment were able to crossover and receive 2 mg/kg bw or 10 mg/kg bw of pembrolizumab every 3 weeks in a double-blind fashion. Patients were randomised (1:1) to one of the following treatment arms: pembrolizumab 200 mg intravenously every 3 weeks in combination with lenvatinib 20 mg orally once daily. The primary OS analysis was not adjusted to account for subsequent therapies. Among the 994 patients, the baseline characteristics were: median age of 60 years (range: 25 to 84), 33% age 65 or older; 71% male; and 85% ECOG PS of 0 and 15% ECOG PS of 1. For efficacy data in patients 75 years of age please refer to the relevant section of each indication. These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. Based on the stratified Cox regression model, Sevilla y Entorno. The following additional clinically significant, immune-related adverse reactions have been reported in clinical studies or in post-marketing experience: uveitis, arthritis, myositis, myocarditis, pancreatitis, Guillain-Barr syndrome, myasthenic syndrome, haemolytic anaemia, sarcoidosis, encephalitis, myelitis, vasculitis, cholangitis sclerosing, gastritis, cystitis noninfective and hypoparathyroidism (see sections 4.2 and 4.8). KEYTRUDA is a humanised monoclonal antibody which binds to the programmed cell death-1 (PD-1) receptor and blocks its interaction with ligands PD-L1 and PD-L2. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. The majority of adverse reactions reported for monotherapy were of Grades 1 or 2 severity. K|m[!X()^5HLWhT7? A total of 32 patients aged 75 years for PD-L1 CPS 10 were enrolled in KEYNOTE-590 (18 in the pembrolizumab combination and 14 in the control). A total of 1,174 patients were randomised. 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. Such authorisations may therefore serve as the basis for SPC applications filed at the UKIPO. Hyperthyroidism may be managed symptomatically. KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation. Immune-related severe skin reactions have been reported in patients receiving pembrolizumab (see section 4.8). Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Immune-related adverse reactions have also occurred after the last dose of pembrolizumab. Enrolment of adolescents completed in June 2021. KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is indicated for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a CPS 1 (see section 5.1). Results of KEYNOTE-361 for pembrolizumab in combination with chemotherapy did not show statistically significant improvement in PFS as assessed by BICR using RECIST 1.1 (HR 0.78; 95% CI: 0.65, 0.93; p=0.0033), and OS (HR 0.86; 95% CI: 0.72, 1.02; p=0.0407) versus chemotherapy alone. /Creator (PScript5.dll Version 5.2.2) For Grade 4 haematological toxicity, only in patients with cHL, KEYTRUDA should be withheld until adverse reactions recover to Grades 0-1. Table 20: Efficacy results in KEYNOTE-087 and KEYNOTE-013, Based on Kaplan-Meier estimation, Figure 22: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-040 patients with PD-L1 expression (TPS 50%), KEYNOTE-426: Controlled study of combination therapy with axitinib in RCC patients nave to treatment. IRO = Integrated radiology and oncologist assessment using RECIST 1.1, 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. If not used immediately, in-use storage times and conditions are the responsibility of the user. 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. Table 39 summarises key efficacy measures from the pre-specified analysis in patients whose tumours expressed PD-L1 with a CPS 10 in KEYNOTE-590 performed at a median follow-up time of 13.5 months (range: 0.5 to 32.7 months). This medicinal product must not be mixed with other medicinal products or diluted. Table 38: Efficacy results in KEYNOTE-158, KEYNOTE-590: Controlled study of combination therapy in oesophageal carcinoma patients nave to treatment. an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed. Pharmacotherapeutic group: Vaccine, other viral vaccines, ATC code: J07BX03. Patients treated with KEYTRUDA must be given the patient alert card and be informed about the risks of KEYTRUDA (see also package leaflet). Upon enrolment, participants were stratified by age (18 to 64 years; 65 to 84 years) to receive Nuvaxovid or placebo. Patients were randomised (1:1:1) to receive pembrolizumab 10 mg/kg bw every 2 (n=279) or 3 weeks (n=277) or ipilimumab 3 mg/kg bw every 3 weeks (n=278). /Parent 3 0 R Table 31 summarises key efficacy measures and Figures 23 and 24 show the Kaplan-Meier curves for OS and PFS based on the final analysis with a median follow-up time of 37.7 months. Treatment with pembrolizumab continued until RECIST v1.1-defined progression of disease as determined by the investigator or unacceptable toxicity. Assessment of tumour status was performed at Weeks 8, 16, and 24, then every 9 weeks for the first year, and every 12 weeks thereafter. 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. Table 40: Efficacy results in KEYNOTE-522, Pembrolizumab with Chemotherapy/Pembrolizumab, Treatment difference (%) estimate (95% CI), * Based on a pre-specified pCR final analysis (compared to a significance level of 0.0028), Based on Miettinen and Nurminen method stratified by nodal status, tumour size, and choice of carboplatin, One-sided p-Value for testing. Participants with clinically stable underlying comorbidity were included as were participants with well-controlled HIV infection. 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). Chemotherapy as first-line treatment in subjects with advanced or metastatic urothelial carcinoma with. No dose adjustment is necessary in patients 75 years of age please refer to the section... 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