mhra spcmhra spc
Assessment of tumour status was performed at 12 weeks, then every 6 weeks through Week 48, followed by every 12 weeks thereafter. The baseline characteristics of these 599 patients included: median age 63 years (45% age 65 or older); 69% male; 63% White and 32% Asian; 17% Hispanic or Latino; and ECOG performance status 0 and 1 in 31% and 69%, respectively. Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. Do not co-administer other medicinal products through the same infusion line. Animal fertility studies have not been conducted with pembrolizumab. Of these patients, 55% had no recurrence of ALT > 3 times ULN, and of those patients with recurrence of ALT > 3 times ULN, all recovered. Until further data become available, careful consideration to the potential benefits of HSCT and the possible increased risk of transplant-related complications should be made case by case (see section 4.8). 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 has not been studied in patients with severe hepatic impairment (see sections 4.4 and 5.2). 16 0 obj Of these, 66 out of 95 (69%) were identified as the Alpha variant with the other cases classified as non-Alpha. Marketing authorisation holder 8. There is limited experience with use of Nuvaxovid in pregnant women. endobj /Parent 3 0 R There were no Grade 5 hepatic events. Reasons for cisplatin ineligibility included: baseline creatinine clearance of < 60 mL/min (50%), ECOG performance status of 2 (32%), ECOG performance status of 2 and baseline creatinine clearance of < 60 mL/min (9%), and other (Class III heart failure, Grade 2 or greater peripheral neuropathy, and Grade 2 or greater hearing loss; 9%). A certificate of Good Manufacturing Practice (GMP) is issued to a manufacturer if the outcome of the inspection confirms that the manufacturer complies with the principles of Good Manufacturing Practice. Assessment of tumour status was performed at Week 6 and Week 12, followed by every 9 weeks thereafter. Table 10: Efficacy results in KEYNOTE-716, * Based on the stratified Cox proportional hazard model. The majority of adverse reactions reported for monotherapy were of Grades 1 or 2 severity. When administering KEYTRUDA as part of a combination with intravenous chemotherapy, KEYTRUDA should be administered first. The primary efficacy outcome measures were OS and PFS as assessed by investigator according to RECIST v1.1. Pneumonitis occurred in 324 (4.2%) patients, including Grade 2, 3, 4 or 5 cases in 143 (1.9%), 81 (1.1%), 19 (0.2%) and 9 (0.1%) patients, respectively, receiving pembrolizumab. Participants were enrolled across 28 tumour types by primary diagnosis. The study excluded patients with EGFR or ALK genomic tumour aberrations; autoimmune disease that required systemic therapy within 2 years of treatment; a medical condition that required immunosuppression; or who had received more than 30 Gy of thoracic radiation within the prior 26 weeks. Patients had PD-L1 expression with a 1% TPS based on the PD-L1 IHC 22C3 pharmDxTM Kit. arthritis (joint swelling, polyarthritis and joint effusion), ee. Figure 4: Kaplan-Meier curve for recurrence-free survival by treatment arm in KEYNOTE-716 (intent to treat population), Figure 5: Kaplan-Meier curve for distant metastasis-free survival by treatment arm in KEYNOTE-716 (intent to treat population), KEYNOTE-054: Placebo-controlled study for the adjuvant treatment of patients with completely resected Stage III melanoma. The median time to onset of nephritis was 4.2 months (range 12 days to 21.4 months). If you use assistive technology (such as a screen reader) and need a Table 38: Efficacy results in KEYNOTE-158, KEYNOTE-590: Controlled study of combination therapy in oesophageal carcinoma patients nave to treatment. Enhertu 100 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC) - (emc) Enhertu 100 mg powder for concentrate for solution for infusion Active Ingredient: trastuzumab deruxtecan Company: Daiichi Sankyo UK Limited See contact details ATC code: L01XC41 About Medicine Prescription only medicine All patients had M1 disease. Demographic characteristics were similar among participants who received Nuvaxovid and those who received placebo. Pembrolizumab was administered prior to chemotherapy on Day 1. From a microbiological point of view, after first opening (first needle puncture), the vaccine should be used immediately. << KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous non-small cell lung carcinoma in adults. Well send you a link to a feedback form. 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. Assessed by investigator using RECIST 1.1, # One-sided p-Value for testing. The geometric mean value (CV%) for the terminal half-life is 22 days (32%) at steady-state. This. At the time of this analysis, the Delta (B.1.617.2 and AY lineages) variant of concern (VOC) was the predominant variant circulating in the US and accounted for all cases from which sequence data are available (11/20, 55%). Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk or you can search for MHRA Yellow Card in the Google Play or Apple App Store. The patient may also choose to report any adverse drug reaction direct to the MHRA on a Yellow Card , available at pharmacies, GP surgeries or from the Yellow Card hotline (freephone 0808 100 3352 during business hours). 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. KEYTRUDA should be withheld or discontinued to manage adverse reactions as described in Table 1. Name of the medicinal product 2. Tourist area. The dispersion is colourless to slightly yellow, clear to mildly opalescent (pH 7.2). H0: difference in % = 0 versus H1: difference in % > 0,
Patients with non-squamous NSCLC could receive pemetrexed maintenance.). % You can change your cookie settings at any time. The study excluded participants who were significantly immunocompromised due to immunodeficiency disease; current diagnosis or treatment for cancer; autoimmune disease/condition; received chronic immunosuppressive therapy or received immunoglobulin or blood-derived products within 90 days; bleeding disorder or continuous use of anticoagulants; history of allergic reactions and/or anaphylaxis; were pregnant; or had a history of laboratory-confirmed diagnosed COVID-19. 09/24. All but two patients were white. The most frequent adverse reactions were injection site tenderness (71%), injection site pain (67%), headache (63%), myalgia (57%), fatigue (54%), malaise (43%), nausea or vomiting (23%), arthralgia (19%) and pyrexia (17%). Allogeneic HSCT prior to treatment with pembrolizumab. Events of anaphylaxis have been reported with Nuvaxovid vaccines. 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). The potential risk of gastrointestinal perforation should be taken into consideration. >> Agency (MHRA), alongside European Health Authorities, has been investigating ranitidine products manufactured for the UK market. Hazard ratio (pembrolizumab compared to standard treatment) based on the stratified Cox proportional hazard model,
The primary efficacy outcome measure was investigator-assessed disease-free survival (DFS). /Parent 3 0 R Assessed by BICR using RECIST 1.1,
Hyperthyroidism occurred in 394 (5.2%) patients, including Grade 2 or 3 cases in 108 (1.4%) and 9 (0.1%) patients, respectively, receiving pembrolizumab. The most common Variants of Concern identified were: Alpha with 31/61 cases (51%), Beta (2/61, 4%) and Gamma (2/61, 4%), while the most common Variants of Interest were Iota with 8/61 cases (13%), and Epsilon (3/61, 5%). Do not shake. For patients with Grade 3 or Grade 4 endocrinopathies that improved to Grade 2 or lower and are controlled with hormone replacement, if indicated, continuation of pembrolizumab may be considered after corticosteroid taper, if needed. Description of selected adverse reactions. There was no evidence of an altered pharmacokinetic or safety profile with anti-pembrolizumab binding or neutralising antibody development. /MediaBox [0 0 595 842] K|m[!X()^5HLWhT7? 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. One-sided p-Value based on stratified log-rank test,
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,
If not used immediately, in-use storage times and conditions are the responsibility of the user. A direct comparison of pembrolizumab when used in combination with chemotherapy to pembrolizumab monotherapy is not available. A total of 121/411 (29%) of the pembrolizumab and lenvatinib-treated patients received continued study therapy beyond RECIST-defined disease progression. KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence (see section 5.1). Randomisation was stratified by tumour PD-L1 expression (TPS 50% or < 50%), HPV status (positive or negative), and ECOG PS (0 vs. 1). Currently available data are described in sections 4.8, 5.1 and 5.2. KEYNOTE-010: Controlled study of NSCLC patients previously treated with chemotherapy. /Creator (PScript5.dll Version 5.2.2) Pembrolizumab in combination with chemotherapy (see section 4.2). Pembrolizumab may be restarted within 12 weeks after last dose of KEYTRUDA if the adverse reaction recovers to Grade 1 and corticosteroid dose has been reduced to 10 mg prednisone or equivalent per day. Mild COVID-19 was defined as fever, new onset cough or at least 2 or more additional COVD-19 symptoms. Administration of study treatment was permitted beyond RECIST-defined disease progression if the treating investigator considered the patient to be deriving clinical benefit and the treatment was tolerated. If indicated, patients received adjuvant radiation therapy prior to or concurrent with adjuvant pembrolizumab or placebo. Among the study population (355 patients in the pembrolizumab with lenvatinib arm and 357 in the sunitinib arm), the baseline characteristics were: median age of 62 years (range: 29 to 88 years), 41% age 65 or older; 74% male; 75% White, 21% Asian, 1% Black, and 2% other races; 17% and 83% of patients had a baseline KPS of 70 to 80 and 90 to 100, respectively; patient distribution by IMDC risk categories was 33% favourable, 56% intermediate and 10% poor, and by MSKCC prognostic groups was 27% favourable, 64% intermediate and 9% poor. Of gastrointestinal perforation should be postponed in individuals suffering from an acute severe febrile illness or acute.! 28 tumour types by primary diagnosis weeks thereafter currently available data are described in table 1 is limited experience use... Severe hepatic impairment ( see sections 4.4 and 5.2 ) described in sections 4.8, 5.1 and )... 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