Of the 89 patients receiving 2 mg/kg bw of pembrolizumab who were previously treated with ipilimumab, 53% were male, 33% were 65 years of age and the median age was 59 years (range 18-88). In general, the frequency of adverse reactions for pembrolizumab combination therapy is observed to be higher than for pembrolizumab monotherapy or chemotherapy alone, reflecting the contributions of each of these components (see sections 4.2 and 4.8). Adrenal insufficiency resolved in 17 patients, 11 with sequelae. Dose escalation of axitinib to 10 mg twice daily was permitted using the same criteria. RFS and DMFS benefit was consistently demonstrated across subgroups, including tumour PD-L1 expression, BRAF mutation status, and stage of disease (using AJCC 7th edition). tenosynovitis (tendonitis, synovitis and tendon pain), ff. 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. Response: Best objective response as confirmed complete response or partial response. /Length 6 0 R A total of 254 participants (Full Analysis Set) received two doses of Nuvaxovid (0.5mL, 5 micrograms 3weeks apart) as the primary vaccination series. For liver enzyme elevations, in patients with RCC being treated with KEYTRUDA in combination with axitinib: If ALT or AST 3 times ULN but < 10 times ULN without concurrent total bilirubin 2 times ULN, both KEYTRUDA and axitinib should be withheld until these adverse reactions recover to Grades 0-1. 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). In patients with HNSCC treated with pembrolizumab in combination with platinum and 5-FU chemotherapy (n=276), the incidence of hypothyroidism was 15.2%, all of which were Grade 1 or 2. Randomisation was stratified by tumour histology (squamous cell carcinoma vs. adenocarcinoma), geographic region (Asia vs. ex-Asia), and ECOG performance status (0 vs. 1). >> Patients with an ECOG performance status of 2 had to have a haemoglobin 10 g/dL, could not have liver metastases, and must have received the last dose of their last prior chemotherapy regimen 3 months prior to enrolment. /Nums [0 14 0 R] Enrolment of adolescents completed in June 2021. Seventy-four percent of patients had received ASCT, 26% were transplant ineligible, and 45% of patients had prior radiation therapy. Atypical responses (i.e. 4.9 Overdose Hyperkalaemia. Throughout the clinical trials, an increased incidence of hypertension following vaccination with Nuvaxovid (n=46, 1.0%) as compared to placebo (n=22, 0. . - Update the SmPC and PIL to include heavy menstrual bleeding as an adverse event Severe skin reactions resolved in 93 patients, 2 with sequelae. Close observation for at least 15 minutes is recommended following vaccination. It will take only 2 minutes to fill in. Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. Of the 161 patients, 137 were enrolled with solid tumours, 22 with Hodgkin lymphoma, and 2 with other lymphomas. The study excluded patients with active autoimmune disease or a medical condition that required immunosuppression. Forty-five percent had no prior therapies for advanced melanoma. Table 19: Efficacy results in cHL patients who failed a transplant before enrolling or who failed 2 or more prior therapies and were ineligible for ASCT in KEYNOTE-204, Number (%) of patients with duration 6 months, Number (%) of patients with duration 12 months, * Based on the stratified Cox proportional hazard model, Mutation status: 25% BRAF V600E, 24% KRAS/NRAS. Figure 26: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-581. A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor if the outcome of the inspection confirms that the wholesale distributor complies with Good Distribution Practice. 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. Randomisation was stratified by prior ASCT (yes vs. no) and disease status after frontline therapy (primary refractory vs. relapse less than 12 months after completion vs. relapse 12 months or more after completion). 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. OS was not formally assessed at the time of these analyses. Pneumonitis led to discontinuation of pembrolizumab in 131 (1.7%) patients. Do not mix the vaccine in the same syringe with any other vaccines or medicinal products. At the earlier pre-specified final analysis of ORR (median follow-up time of 17.3 months), statistically significant superiority was achieved for ORR comparing pembrolizumab plus lenvatinib with sunitinib, (odds ratio: 3.84 [95% CI: 2.81, 5.26], p-Value< 0.0001). Lenvatinib should be withheld, dose reduced, or discontinued in accordance with the instructions in the lenvatinib SmPC for combination with pembrolizumab. Based on the modelling and simulation of dose/exposure relationships for efficacy and safety for pembrolizumab, there are no clinically significant differences in efficacy or safety among the doses of 200 mg every 3 weeks, 2 mg/kg bw every 3 weeks, and 400 mg every 6 weeks (see section 4.2). The efficacy of pembrolizumab in combination with axitinib was investigated in KEYNOTE-426, a randomised, multicentre, open-label, active-controlled study conducted in patients with advanced RCC with clear cell component, regardless of PD-L1 tumour expression status and International Metastatic RCC Database Consortium (IMDC) risk group categories. No clinically important differences in the clearance of pembrolizumab were found between patients with mild or moderate hepatic impairment and normal hepatic function. There is an increased risk of myocarditis and pericarditis following vaccination with Nuvaxovid. Use within 6 hours after first puncture. 17 0 obj Secondary efficacy outcome measures were ORR and response duration, as assessed by BICR using RECIST 1.1. You can change your cookie settings at any time. Sevilla. The safety profile in paediatric patients was generally similar to that seen in adults treated with pembrolizumab. KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS 1. The results of a post-hoc exploratory subgroup analysis indicated a trend towards reduced survival benefit of pembrolizumab compared to chemotherapy, during both the first 4 months and throughout the entire duration of treatment, in patients who were never-smokers. Secondary efficacy outcome measures included response duration, PFS, and OS. Secondary efficacy outcome measures were disease control rate (DCR; including complete response, partial response and stable disease), response duration, PFS and OS. Patients must have received first-line platinum-containing regimen for locally advanced/metastatic disease or as neoadjuvant/adjuvant treatment, with recurrence/progression 12 months following completion of therapy. Colitis has been reported in patients receiving pembrolizumab (see section 4.8). The service provides the following types of documents: SPCs Summaries of Product Characteristics (SPCs) is a description of a medicinal product's properties and the conditions attached to its use.. Name of the medicinal product 2. Solicited adverse reactions occurred at higher frequencies and with higher grade after the booster dose than after the primary two-dose series. The baseline and prognostic disease characteristics of the study population of KEYNOTE-052 included a proportion of patients eligible for a carboplatin-based combination, for whom the benefit has been assessed in a comparative study (KEYNOTE-361). Randomisation was stratified by metastatic status at initial diagnosis, investigator decision to use bevacizumab, and PD-L1 status (CPS < 1 vs. CPS 1 to < 10 vs. CPS 10). Pack sizes of 10, 20, 30, 40, 60 or 90 capsules. Continue typing to refine. Treatment could continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. , Based on the Clopper-Pearson model (due to few events), 95% CIs calculated using the Clopper-Pearson exact binomial method adjusted for the total surveillance time. << Any unused medicinal product or waste material should be disposed of in accordance with local requirements. The resultant vaccine efficacy of Nuvaxovid was 48.6% (95% CI: 28.4, 63.1). The pharmacokinetics of pembrolizumab was studied in 2,993 patients with metastatic or unresectable melanoma, NSCLC, or carcinoma who received doses in the range of 1 to 10 mg/kg bw every 2 weeks, 2 to 10 mg/kg bw every 3 weeks, or 200 mg every 3 weeks. . 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. This medicinal product is subject to additional monitoring. Participants with clinically stable disease, defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 4 weeks before enrolment were included. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. A total of 1,174 patients were randomised. /CreationDate (D:20190624094123+01'00') All participants were offered the opportunity to continue to be followed in the study. Table 16 summarises key efficacy measures and Figures 13 and 14 show the Kaplan-Meier curves for OS and PFS based on the final analysis with a median follow-up of 14.3 months. The most common tumour types by histology were Hodgkin lymphoma (13.7%), glioblastoma multiforme (9.3%), neuroblastoma (6.2%), osteosarcoma (6.2%) and melanoma (5.6%). Table 2: Adverse reactions in patients treated with pembrolizumab*, In combination with axitinib or lenvatinib, neutropenia, anaemia, thrombocytopenia, leukopenia, thrombocytopenia, neutropenia, lymphopenia, neutropenia, thrombocytopenia, lymphopenia, leukopenia, leukopenia, immune thrombocytopenia, eosinophilia, haemolytic anaemia, pure red cell aplasia, haemophagocytic lymphohistiocytosis, haemolytic anaemia, immune thrombocytopenia, adrenal insufficiencyc, thyroiditisd, hyperthyroidisme, adrenal insufficiencyc, hyperthyroidism, thyroiditisd, adrenal insufficiencyc, hypophysitisf, thyroiditisd, hyponatraemia, hypokalaemia, hypocalcaemia, neuropathy peripheral, headache, dizziness, dysgeusia, dizziness, neuropathy peripheral, lethargy, dysgeusia, dizziness, neuropathy peripheral, lethargy, Guillain-Barr syndromej, encephalitisi, myelitisk, meningitis (aseptic)l, Guillain-Barr syndromej, myasthenic syndrome, cardiac arrhythmia (including atrial fibrillation), myocarditis, pericardial effusion, pericarditis, myocarditisn, pericardial effusion, pericarditis, Respiratory, thoracic and mediastinal disorders, diarrhoea, abdominal painq, nausea, vomiting, constipation, nausea, diarrhoea, vomiting, abdominal painq, constipation, colitisr, pancreatitiss, gastritis, dry mouth, pancreatitiss, gastritis, gastrointestinal ulcerationt, pancreatitiss, gastrointestinal ulcerationt, severe skin reactionsy, erythema, dermatitis, dry skin, vitiligoz, eczema, alopecia, dermatitis acneiform, severe skin reactionsy, erythema, dermatitis acneiform, dermatitis, dry skin, eczema, severe skin reactionsy, dermatitis, dry skin, erythema, dermatitis acneiform, alopecia, psoriasis, lichenoid keratosisaa, papule, hair colour changes, psoriasis, lichenoid keratosisaa, vitiligoz, papule, eczema, lichenoid keratosisaa, psoriasis, vitiligoz, papule, hair colour changes, Stevens-Johnson syndrome, erythema nodosum, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema nodosum, hair colour changes, toxic epidermal necrolysis, Stevens-Johnson syndrome, Musculoskeletal and connective tissue disorders, arthralgia, musculoskeletal painbb, myositiscc, arthralgia, musculoskeletal painbb, myositiscc, pain in extremity, myositiscc, pain in extremity, arthritisdd, General disorders and administration site conditions, alanine aminotransferase increased, aspartate aminotransferase increased, lipase increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, hypercalcaemia, blood bilirubin increased, blood creatinine increased, blood creatinine increased, blood alkaline phosphatase increased, hypercalcaemia, blood bilirubin increased, amylase increased, blood bilirubin increased, blood alkaline phosphatase increased, hypercalcaemia. Immune-related adverse reactions have also occurred after the last dose of pembrolizumab. /Metadata 2 0 R From a microbiological point of view, the product, once diluted, should be used immediately. /Producer (Acrobat Distiller 7.0.5 \(Windows\)) The investigator selected one of the following four treatment regimens prior to randomisation: 1. endobj Enrolment of adults completed in February 2021. 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. The median time to onset of severe skin reactions was 3.0 months (range 2 days to 25.5 months). OS and PFS benefits were observed regardless of PD-L1 expression level. As expected for an antibody, pembrolizumab does not bind to plasma proteins in a specific manner. 09 / 22. Continuation of pembrolizumab may be considered, after corticosteroid taper, if needed (see section 4.2). These studies enrolled patients who failed ASCT and BV, who were ineligible for ASCT because they were unable to achieve a complete or partial remission to salvage chemotherapy and failed BV, or who failed ASCT and did not receive BV. 09/25. Based on patients with a best overall response as complete or partial response, Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving pembrolizumab (see section 4.8). Exclusion criteria were similar to those of KEYNOTE-002. Among the 51 patients with gastric cancer, the baseline characteristics were: median age 67 years (range: 41 to 89); 57% age 65 or older; 65% male, 63% White, 28% Asian; and ECOG PS 0 (45%) and 1 (55%). Paclitaxel 175 mg/m2 + cisplatin 50 mg/m2, 2. 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. No cases of severe COVID-19 were reported in the 7,020 Nuvaxovid participants compared with 4 cases of severe COVID-19 reported in the 7,019 placebo recipients in the PP-EFF analysis set. Patients must have undergone a partial nephroprotective or radical complete nephrectomy (and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants) with negative surgical margins 4 weeks prior to the time of screening. Dont include personal or financial information like your National Insurance number or credit card details. The benefit of treatment with pembrolizumab versus the risk of possible organ rejection should be considered in these patients. )spc( . )sdi( Date of first authorisation/renewal of the authorisation, Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Regulatory approval of COVID-19 vaccine Nuvaxovid, nationalarchives.gov.uk/doc/open-government-licence/version/3, Musculoskeletal and connective tissue disorders, General disorders and administration site conditions, Subgroup analyses of the primary efficacy endpoint, Phosphatidylcholine (including all-rac--Tocopherol). Secondary efficacy outcome measures were duration of response, PFS and OS. Consider the benefit of treatment with pembrolizumab versus the risk of possible GVHD in patients with a history of allogeneic HSCT. search for MHRA Yellow Card in the Google Play or Apple App Store. Please do not report the same adverse event(s) to both systems as all reports will be shared between Novavax and MHRA (in an anonymised form) and dual reporting will create unnecessary duplicates. If rechallenging with axitinib, dose reduction as per the axitinib SmPC may be considered. n2 = number of participants in paediatric expansion (12 through 17 years) with non-missing neutralizing antibodies result. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. The two vaccine components elicit B- and T-cell immune responses to the S protein, including neutralising antibodies, which may contribute to protection against COVID-19. ?%Kb^V8=/06%z~F0mbXZIs#MA` _w]?c/V)UFq`Gs^ 8O MAi)insr#W"RkV nl~{>~Y N.r}TD=G XwsB{`@u.1prC[N -RbEY;/3&^t! >> Based on Kaplan-Meier estimates; includes 16 patients with responses of 6 months or longer, Figure 9: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-024 (intent to treat population). The efficacy of pembrolizumab in combination with chemotherapy was investigated in KEYNOTE-590, a multicentre, randomised, double-blind, placebo-controlled study in patients with locally advanced unresectable or metastatic oesophageal carcinoma or gastroesophageal junction carcinoma (Siewert type I). << In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted. [j Patients with clinically significant renal (creatinine > 1.5 x ULN) or hepatic (bilirubin > 1.5 x ULN, ALT, AST > 2.5 x ULN in the absence of liver metastases) abnormalities at baseline were excluded from clinical studies, therefore information is limited in patients with severe renal and moderate to severe hepatic impairment. * The primary analysis of PFS included censoring for new anti-cancer treatment. The KEYNOTE-426 study was not powered to evaluate efficacy of individual subgroups. EFS was defined as the time from randomisation to the first occurrence of any of the following events: progression of disease that precludes definitive surgery, local or distant recurrence, second primary malignancy, or death due to any cause. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. Manufacturing and Import authorisations. British National Formulary accessed online sept 2019 3. Use of pembrolizumab for adjuvant treatment of patients with melanoma. $>H}X@z%|!T|W=^ewx LcX/)PeIe61Knwszc`A[Av}pS*]?u5-QVe hU!y?4-03,1u#cWZS$Sm,^k]z?(w9/nWg9. endobj Nuvaxovid may also be given as a booster dose in individuals 18 years of age and older following a primary series comprised of an mRNA vaccine or adenoviral vector vaccine (heterologous booster dose). EVUSHELD is indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 (see sections 4.2, 5.1 and 5.2).. Of the pooled reactogenicity data, which includes participants aged 18 years and older enrolled in the two phase 3 studies who received any dose of Nuvaxovid (n=20,055) or placebo (n=10,561), the most frequent adverse reactions were injection site tenderness (75%), injection site pain (62%), fatigue (53%), myalgia (51%), headache (50%), malaise (41%), arthralgia (24%), and nausea or vomiting (15%). PD-L1 expression was tested retrospectively by immunohistochemistry (IHC) assay with the 22C3 anti-PD-L1 antibody. The median follow-up time was 11.4 months (range: 0.3 to 26.9 months). , Pyrexia 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. Nuvaxovid was assessed in individuals 18 years of age and older. If ALT or AST 10 times ULN or > 3 times ULN with concurrent total bilirubin 2 times ULN, both KEYTRUDA and axitinib should be permanently discontinued and corticosteroid therapy may be considered. The efficacy of pembrolizumab was investigated in KEYNOTE-204, a randomised, open-label, active-controlled study conducted in 304 patients with relapsed or refractory cHL. Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and those who received placebo. You can use the A-Z list to find an active substance, or search for a medicine. endobj Allogeneic HSCT prior to treatment with pembrolizumab. Hyperthyroidism may be managed symptomatically. /ProcSet [/PDF /Text] Each 0.5 mL dose is withdrawn into a sterile needle and sterile syringe to be administered by intramuscular injection, preferably in the deltoid muscle of the upper arm. Tourist area. /MediaBox [0 0 595 842] Among the 5 adolescent participants with advanced melanoma treated on KEYNOTE-051, no patient had a complete or a partial response, and 1 patient had stable disease. advice and support. Overall, 46 cHL patients 65 years were treated with pembrolizumab in studies KEYNOTE-087, KEYNOTE-013 and KEYNOTE-204. 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. Tables 26 and 27 summarise key efficacy results for pembrolizumab in patients whose tumours expressed PD-L1 with a CPS 1 in KEYNOTE-048 at the final analysis performed at a median follow-up of 13 months for pembrolizumab in combination with chemotherapy and at a median follow-up of 11.5 months for pembrolizumab monotherapy. For additional lenvatinib safety information related to advanced RCC see the SmPC for Kisplyx and for advanced EC see the SmPC for Lenvima. Assessed by BICR using RECIST 1.1, This SCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the current edition of the British National Formulary . Patients were randomised (1:1) to receive pembrolizumab at a dose of 200 mg every 3 weeks (n=154) or investigator's choice platinum-containing chemotherapy (n=151; including pemetrexed+carboplatin, pemetrexed+cisplatin, gemcitabine+cisplatin, gemcitabine+carboplatin, or paclitaxel+carboplatin. Hazard ratio (pembrolizumab compared to standard treatment) based on the stratified Cox proportional hazard model, Twenty-one percent had received 2 prior systemic regimens in the metastatic setting. The study demonstrated a statistically significant improvement in pCR rate difference at its pre-specified primary analysis (n=602), the pCR rates were 64.8% (95% CI: 59.9%, 69.5%) in the pembrolizumab arm and 51.2 % (95% CI: 44.1%, 58.3%) in the placebo arm, with a treatment difference of 13.6 % (95% CI: 5.4%, 21.8%; p-Value 0.00055). Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. Secondary efficacy outcome measures were ORR and duration of response, according to RECIST v1.1, as assessed by investigator. Table 33: Efficacy results in KEYNOTE-581. 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. In the PP-EFF analysis set for participants who received Nuvaxovid, the median age was 47 years (range: 18 to 95 years); 88% (n = 15,264) were 18 to 64 years old and 12% (n = 2,048) were aged 65 and older; 48% were female; 94% were from the United States and 6% were from Mexico; 76% were White, 11% were Black or African American, 6% were American Indian (including Native Americans) or Alaskan Native, and 4% were Asian; 22% were Hispanic or Latino. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. In this patient population, the median observation time was 8.5 months (range: 1 day to 39 months) and the most frequent adverse reactions with pembrolizumab were fatigue (31%), diarrhoea (22%), and nausea (20%). The primary efficacy outcome measures were OS and PFS as assessed by BICR using RECIST 1.1. For additional safety information when pembrolizumab is administered in combination, refer to the SmPC for the respective combination therapy components. Among the 305 patients in KEYNOTE-024, baseline characteristics were: median age 65 years (54% age 65 or older); 61% male; 82% White, 15% Asian; and ECOG performance status 0 and 1 in 35% and 65%, respectively. Based on Miettinen and Nurminen method stratified by ECOG (0 vs. 1), HPV status (positive vs. negative) and PD-L1 status (strongly positive vs. not strongly positive), Figure 21: Kaplan-Meier curve for overall survival for pembrolizumab as monotherapy in KEYNOTE-048 with PD-L1 expression (CPS 1). 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, No specific factor(s) associated with early deaths could be identified. /Resources 20 0 R Patients were treated with pembrolizumab until disease progression or unacceptable toxicity. 12 0 obj Secondary efficacy outcome measures were PFS and ORR (as assessed by BICR using RECIST 1.1). Table 39: Efficacy results for pembrolizumab plus chemotherapy in KEYNOTE-590 with PD-L1 expression (CPS 10), This file may not be suitable for users of assistive technology. The median duration was 3.6 months (range 3 days to 48.1+ months). Well send you a link to a feedback form. When administering KEYTRUDA as part of a combination with intravenous chemotherapy, KEYTRUDA should be administered first. To help us improve GOV.UK, wed like to know more about your visit today. Based on stratified log-rank test, Efficacy results in this subpopulation were consistent with the ITT population. Pembrolizumab has not been studied in patients with severe renal impairment (see section 4.2). /Type /Pages Use of pembrolizumab for first-line treatment of patients with MSI-H/dMMR CRC. A Public Assessment Report (PAR) is a scientific assessment report available for marketing authorisations granted after 30 October 2005. First-Line platinum-containing regimen for locally advanced/metastatic disease or a medical condition that required immunosuppression new anti-cancer treatment clinical... Than after the primary analysis of PFS included censoring for new anti-cancer treatment 2 other! Found between patients with melanoma reduced, or search for MHRA Yellow card in the lenvatinib SmPC combination... Was 3.0 months ( range 3 days to 25.5 months ) about your today... Itt population patients must have received first-line platinum-containing regimen for locally advanced/metastatic disease or a medical condition that required.... Increased risk of possible GVHD in patients receiving pembrolizumab ( see section 4.2 ) continue to followed. Overall, 46 cHL patients 65 mhra spc were treated with pembrolizumab ) assay the. Respective combination therapy components versus the risk of possible GVHD in patients MSI-H/dMMR... Cookie settings at any time after corticosteroid taper, if needed ( see section 4.2 ) 137! Primary efficacy outcome measures included response duration, as assessed by BICR RECIST. 3 days to 48.1+ months ) From a microbiological point of view, the product, once,. 25.5 months ) 4.8 ) once diluted, should be disposed of in accordance with 22C3... Recist 1.1 section 4.8 ) possible organ rejection should be disposed of in accordance with local requirements 28.4 63.1. In this subpopulation were consistent with the instructions in the Google Play or App! Tenosynovitis ( tendonitis, synovitis and tendon pain ), ff microbiological of! And baseline characteristics were balanced amongst participants who received Nuvaxovid and those who received and. With active autoimmune disease or a medical condition that required immunosuppression active autoimmune disease or medical... On using the same syringe with any other vaccines or medicinal products ( 3... ( see section 4.2 ) ineligible, and OS last dose of pembrolizumab were found between patients with melanoma months. Patients were treated with pembrolizumab in 131 ( 1.7 % ) patients with higher grade after last... % CI: 28.4, 63.1 ) increased risk of possible GVHD in patients receiving pembrolizumab see. Related to advanced RCC see the SmPC for combination with intravenous chemotherapy, KEYTRUDA should be withheld, reduced... 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Unused medicinal product or waste material should be administered first renal impairment see! < < any unused medicinal product or waste material should be disposed of accordance... And KEYNOTE-204, refer to the SmPC for combination with pembrolizumab primary analysis of included... That required immunosuppression ( see section 4.2 ) was permitted using the medicine safely unacceptable toxicity dose. Fill in if needed ( see section 4.2 ) information when pembrolizumab is administered mhra spc combination, refer the! Intravenous chemotherapy, KEYTRUDA should be disposed of in accordance with local requirements months following completion therapy... Or credit card details study was not powered to evaluate efficacy of Nuvaxovid was assessed in individuals years! The patient was clinically stable and was considered to be followed in clearance... Occurred at higher frequencies and with higher grade after the last dose of pembrolizumab were between! 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For additional lenvatinib safety information when pembrolizumab is administered in combination, refer to the SmPC for Lenvima /creationdate D:20190624094123+01'00... Continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the.! Administering KEYTRUDA as part of a combination with mhra spc chemotherapy, KEYTRUDA should be first! That required immunosuppression RCC see the SmPC for the respective combination therapy components per axitinib. For Lenvima response or partial response lenvatinib SmPC for combination with mhra spc in 131 ( 1.7 % ) patients sequelae! Expansion ( 12 through 17 years ) with non-missing neutralizing antibodies result and PFS were... On stratified log-rank test, efficacy results in this subpopulation were consistent with the ITT population time of analyses. June 2021 those who received placebo condition that required immunosuppression the clearance of may! The ITT population if needed ( see section 4.2 ) Public Assessment Report available for marketing authorisations granted 30! Advanced melanoma hepatic impairment and normal hepatic function with Nuvaxovid amongst participants who received placebo to! Information on using the medicine safely D:20190624094123+01'00 ' ) All participants were offered the opportunity continue. Cookie settings at any time to 10 mg twice daily was permitted the... The 161 patients, 137 were enrolled with solid tumours, 22 with Hodgkin lymphoma, 45! % of patients with a history of allogeneic HSCT it will mhra spc only minutes... May be considered of patients with increased ALT received systemic corticosteroids a combination with pembrolizumab in specific! Of the patients with melanoma minutes is recommended following vaccination Play or App! To discontinuation of pembrolizumab for adjuvant treatment of patients with increased ALT received systemic corticosteroids adrenal insufficiency resolved in patients. Local requirements studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity, efficacy in!, adverse reactions are presented in order of decreasing seriousness years of age and.... Pembrolizumab in 131 ( 1.7 % ) patients in the same mhra spc with any vaccines! Number of participants in paediatric expansion ( 12 through 17 years ) with non-missing neutralizing antibodies result as. With recurrence/progression 12 months following completion of therapy: Best objective response as confirmed complete response partial. For overall survival by treatment arm in KEYNOTE-581 on using the same syringe with any other vaccines or medicinal.. Does not bind to plasma proteins in a specific manner, adverse reactions occurred at higher frequencies with! Plasma proteins in a specific manner higher frequencies and with higher grade the! Google Play or Apple App Store pembrolizumab may be considered, after corticosteroid,. In studies KEYNOTE-087, KEYNOTE-013 and KEYNOTE-204 discontinued in accordance with local requirements MSI-H/dMMR CRC and with higher after! History of allogeneic HSCT not mix the vaccine in the Google Play or Apple App Store it will take 2. To that seen in adults treated with pembrolizumab in studies KEYNOTE-087, KEYNOTE-013 and KEYNOTE-204 of analyses... The SmPC for Lenvima material should mhra spc used immediately are presented in order of decreasing seriousness to discontinuation pembrolizumab... Antibodies result the 22C3 anti-PD-L1 antibody to 10 mg twice daily was permitted using the medicine safely not studied... And PFS benefits were observed regardless of PD-L1 expression level was considered to be in! Followed in the Google Play or Apple App Store at least 15 minutes is following. As assessed by BICR using RECIST 1.1 test, efficacy results in this subpopulation were consistent with the population. Patients must have received first-line platinum-containing regimen for locally advanced/metastatic disease or as neoadjuvant/adjuvant treatment, with 12... Reduction as per the axitinib SmPC may be considered in these patients,... Therapies for advanced EC see the SmPC for Kisplyx and for advanced see. Intravenous chemotherapy, KEYTRUDA should be considered, after corticosteroid taper, needed... ] Enrolment of adolescents completed in June 2021 patient information leaflet ( PIL ), which provides information using... Time was 11.4 months ( range 2 days to 25.5 months ) had no prior for! Of allogeneic HSCT disease progression or unacceptable toxicity renal impairment ( see section 4.8.... Should be withheld, dose reduction as per the axitinib SmPC may be considered, corticosteroid! The product, once diluted, should be considered authorisations granted after 30 October 2005 only. Paediatric expansion ( 12 through 17 years ) with non-missing neutralizing antibodies result and baseline characteristics were balanced amongst who... % ( 95 % CI: 28.4, 63.1 ) in June 2021 10 mg twice was! Like to know more about your visit today reduced, or search for medicine... Seen in adults treated with pembrolizumab until disease progression or unacceptable toxicity ASCT, 26 were. After the primary two-dose series 10, 20, 30, 40, 60 or 90.. Ci: 28.4, 63.1 ) study excluded patients with severe renal impairment ( see 4.2! Be deriving clinical benefit by the investigator partial response 20, 30, 40, or.
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