Table 23: Response to pembrolizumab 200 mg every 3 weeks in patients with urothelial carcinoma ineligible for cisplatin-containing chemotherapy in KEYNOTE-052, lichenoid keratosis (lichen planus and lichen sclerosus), bb. Expires . Efficacy results are summarised in Table 37. stream Based on Kaplan-Meier estimation, Figure 16: Kaplan-Meier curve for progression-free survival by treatment arm 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, KEYNOTE-087 and KEYNOTE-013: Open-label studies in patients with relapsed or refractory cHL. 2022 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. 3. Cardiology SPC abbreviation meaning defined here. The study excluded patients with autoimmune disease or those receiving immunosuppression; further exclusion criteria were a history of severe or life-threatening immune-related adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment (> 10 mg/day prednisone or equivalent dose) for greater than 12 weeks; ongoing adverse reactions Grade 2 from previous treatment with ipilimumab; previous severe hypersensitivity to other monoclonal antibodies; a history of pneumonitis or interstitial lung disease; HIV, hepatitis B or hepatitis C infection and ECOG Performance Status 2. It allows continued monitoring of the benefit/risk balance of the medicinal product. In the ITT population, the median follow-up time for 151 patients treated with pembrolizumab was 24.9 months (range: 1.8 to 42.0 months). Of the patients randomised to the chemotherapy arm, 55% crossed over and subsequently received treatment with pembrolizumab. The study excluded patients with autoimmune disease, a medical condition that required immunosuppression and patients with more than 2 prior lines of systemic chemotherapy for metastatic urothelial carcinoma. Patients should be monitored for signs and symptoms of pneumonitis. 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. KEYTRUDA should be withheld or discontinued to manage adverse reactions as described in Table 1. 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. Working together across Sussex. arthritis (joint swelling, polyarthritis and joint effusion), ee. Secondary efficacy outcome measures were OS and ORR (as assessed by BICR using RECIST 1.1). This 96-hour hold may include up to 6 hours at room temperature (at or below 25C). The pMMR stratum was further stratified by ECOG performance status, geographic region, and history of pelvic radiation. We also use cookies set by other sites to help us deliver content from their services. Patients who received prior therapy for melanoma other than surgery were ineligible. Table 12 summarises key efficacy measures for the entire intent to treat (ITT) population. In the PP-EFF analysis set for participants who received Nuvaxovid, median age was 28 years (range: 18 to 84 years); 40% were female; 91% were Black/African American; 2% were White; 3% were multiple races, 1% were Asian; and 2% were Hispanic or Latino; and 5.5% were HIV-positive. For storage conditions after dilution of the medicinal product, see section 6.3. The primary efficacy outcome measures were OS and PFS (as assessed by BICR using RECIST 1.1). Dose escalation of axitinib to 10 mg twice daily was permitted using the same criteria. The recommended dose is a single 500 mg intravenous infusion administered following dilution (see sections 4.4 and 6.6). Use of pembrolizumab for first-line treatment of patients with NSCLC. 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 Efficacy results are summarised in Table 38. Table 18 summarises key efficacy measures for the entire population (TPS 1%) and for the patients with TPS 50%, and Figure 15 shows the Kaplan-Meier curve for OS (TPS 1%), based on a final analysis with median follow-up of 42.6 months. Record the date and time of discard on the vial label. Nuvaxovid has no or negligible influence on the ability to drive and use machines. Among these 548 enrolled patients with tumours expressing PD-L1, 273 patients were randomised to pembrolizumab in combination with chemotherapy with or without bevacizumab, and 275 patients were randomised to placebo in combination with chemotherapy with or without bevacizumab. An analysis was performed in KEYNOTE-407 in patients who had PD-L1 TPS < 1% [pembrolizumab plus chemotherapy arm: n=95 (34%) vs. placebo plus chemotherapy arm: n=99 (35%)], TPS 1% to 49% [pembrolizumab plus chemotherapy arm: n=103 (37%) vs. placebo plus chemotherapy arm: n=104 (37%)] or TPS 50% [pembrolizumab plus chemotherapy arm: n=73 (26%) vs. placebo plus chemotherapy arm: n=73 (26%)] (see Table 17). Key secondary efficacy outcome measures included OS and ORR. The primary OS analysis was not adjusted to account for subsequent therapies. Patients treated with KEYTRUDA must be given the patient alert card and be informed about the risks of KEYTRUDA (see also package leaflet). The median interval between the second and the third doses was 165 days. The safety of re-initiating pembrolizumab therapy in patients previously experiencing immune-related myocarditis is not known. /Author () 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). Scientific guidelines with SmPC recommendations. Based on Kaplan-Meier estimates; includes 43 patients with responses of 6 months or longer, Figure 26: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-581. In patients with EC, Grades 3-5 adverse reactions were 89% for pembrolizumab in combination with lenvatinib and 73% for chemotherapy alone. Table 17: Efficacy results by PD-L1 expression in KEYNOTE-407 Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. Each multidose vial contains a colourless to slightly yellow, clear to mildly opalescent dispersion free from visible particles. 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. The exposure multiple between the NOAEL and a human dose of 200 mg was 74. The primary efficacy outcome measure was OS. Chemotherapy could continue per standard of care. The benefit of treatment with pembrolizumab versus the risk of possible organ rejection should be considered in these patients. Dont worry we wont send you spam or share your email address with anyone. Patients who tolerated axitinib 5 mg twice daily for 2 consecutive treatment cycles (i.e. The primary efficacy outcome measure was ORR as assessed by BICR using RECIST 1.1. 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. No dose adjustment is required in elderly individuals 65 years of age. Both studies included patients regardless of PD-L1 expression. 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. The primary efficacy outcome measures were OS and PFS as assessed by investigator according to RECIST v1.1. The median time to onset of colitis was 4.3 months (range 2 days to 24.3 months). Colitis led to discontinuation of pembrolizumab in 48 (0.6%) patients. Close observation for at least 15 minutes is recommended following vaccination. Administration of pembrolizumab was permitted beyond RECIST-defined disease progression if the patient was clinically stable and deriving clinical benefit as determined by the investigator. Efficacy results by MSKCC prognostic group are summarised in Table 34. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. An updated OS analysis was performed when patients receiving pembrolizumab and lenvatinib or sunitinib had a median survival follow-up of 33.4 months. /Contents 15 0 R Approximately 30% were refractory to frontline chemotherapy and ~ 45% had received prior ASCT. Table 14 summarises key efficacy measures and Figures 11 and 12 show the Kaplan-Meier curves for OS and PFS based on the final analysis with a median follow-up of 18.8 months. Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. Animal reproduction studies have not been conducted with pembrolizumab; however, in murine models of pregnancy blockade of PD-L1 signalling has been shown to disrupt tolerance to the foetus and to result in an increased foetal loss (see section 5.3). /ProcSet [/PDF /Text] >> The key efficacy results of pembrolizumab monotherapy in patients for whom carboplatin rather than cisplatin was selected by the investigator as the better choice of chemotherapy were consistent with KEYNOTE-052 results. Figure 32: Kaplan-Meier curve for event-free survival by treatment arm in KEYNOTE-522 (intent to treat population), Figure 33: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-522 (intent to treat population), KEYNOTE-355: Controlled study of combination therapy in TNBC patients previously untreated for metastatic disease. Table 4 summarises key efficacy measures at the final analysis in patients previously treated with ipilimumab, and the Kaplan-Meier curve for PFS is shown in Figure 3. The study excluded patients with autoimmune disease or a medical condition that required immunosuppression. The GMP guidelines of MHRA are known as Orange Guide. Administer the infusion solution intravenously over 30 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 to 5 m in-line or add-on filter. If refrigerated, the vials and/or intravenous bags must be allowed to come to room temperature prior to use. 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). 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. Randomisation was stratified by nodal status (positive vs. negative), tumour size (T1/T2 vs. T3/T4), and choice of carboplatin (dosed every 3 weeks vs. weekly). 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). Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Among the 749 patients in KEYNOTE-590, 383 (51%) had tumours that expressed PD-L1 with a CPS 10 based on the PD-L1 IHC 22C3 pharmDxTM Kit. ATC code: L01FF02. Disease characteristics were: 21% HPV positive and 95% had stage IV disease (stage IVa 21%, stage IVb 6%, and stage IVc 69%). 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. 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. The secondary outcome measures were DMFS and OS in the whole population and in the population with PD-L1 positive tumours. This SCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the current edition of the British National Formulary . /Nums [0 14 0 R] /MediaBox [0 0 595 842] Withdraw the required volume up to 4 mL (100 mg) of concentrate and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL. Jevany, 28163 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. Adjuvant Matrix-M containing per 0.5 mL dose: Fraction-A (42.5 micrograms) and Fraction-C (7.5 micrograms) of Quillaja saponaria Molina extract. No cases of severe COVID-19 were reported in the 17,312 Nuvaxovid participants compared with 4 cases of severe COVID-19 reported in the 8,140 placebo recipients in the PP-EFF analysis set. Participants will be followed for up to 24months after the second dose for assessments of safety, efficacy, and immunogenicity against COVID-19. Seventy-six (47.2%) patients had 1 or more Grades 3 to 5 adverse reactions of which 5 (3.1%) patients had 1 or more adverse reactions that resulted in death. Based on the severity and type of the adverse reaction, pembrolizumab should be withheld for Grade 2 or Grade 3 events and corticosteroids administered. In patients treated with pembrolizumab in combination with chemotherapy, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 44.0% for neutrophils decreased, 29.4% for leucocytes decreased, 26.9% for lymphocytes decreased, 22.1% for haemoglobin decreased, 13.2% for platelets decreased, 11.0% for sodium decreased, 7.7% for phosphate decreased, 6.8% for ALT increased, 6.8% for potassium decreased, 6.1% for glucose increased, 5.6% for AST increased, 3.5% for calcium decreased, 3.2% for potassium increased, 2.9% for creatinine increased, 2.2% for albumin decreased, 2.1% for alkaline phosphatase increased, 2.0% for bilirubin increased, 2.0% for calcium increased, 1.3% for prothrombin INR increased, 1.2% for glucose decreased and 0.5% for sodium increased. << null There is no information on overdose with pembrolizumab. myositis (myalgia, myopathy, necrotising myositis, polymyalgia rheumatica and rhabdomyolysis), dd. Patients were randomised (1:1:1) to receive pembrolizumab at a dose of 2 (n=344) or 10 mg/kg bw (n=346) every 3 weeks or docetaxel at a dose of 75 mg/m2 every 3 weeks (n=343) until disease progression or unacceptable toxicity. Overall, 431 participants were co-vaccinated with inactivated seasonal influenza vaccines; 217 sub-study participants received Nuvaxovid and 214 received placebo. Thirty-seven percent of patients received 2 or more prior lines of therapy. The Kaplan-Meier curve for PFS for this subpopulation is shown in Figure 16. All 827 of these patients received prior systemic therapy for EC: 69% had one, 28% had two, and 3% had three or more prior systemic therapies. R. eview. Patients with active infections were excluded from clinical studies and were required to have their infection treated prior to receiving pembrolizumab. Randomisation was stratified by chemotherapy treatment (paclitaxel or nab-paclitaxel vs. gemcitabine and carboplatin), tumour PD-L1 expression (CPS 1 vs. CPS < 1), and prior treatment with the same class of chemotherapy in the neoadjuvant setting (yes vs. no). The median time to onset of severe skin reactions was 3.0 months (range 2 days to 25.5 months). The primary efficacy outcome measure was ORR as assessed by BICR using RECIST 1.1. Nuvaxovid was assessed in individuals 18 years of age and older. Adrenal insufficiency resolved in 17 patients, 11 with sequelae. 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. The efficacy of pembrolizumab was evaluated in KEYNOTE-716, a multicentre, randomised, double-blind, placebo-controlled study in patients with resected Stage IIB or IIC melanoma. >> A total of 976 patients were randomised (1:1) to receive pembrolizumab 200 mg every three weeks (or the paediatric [12 to 17 years old] dose of 2 mg/kg intravenously [up to a maximum of 200 mg] every three weeks) (n=487) or placebo (n=489), for up to one year or until disease recurrence or unacceptable toxicity. However, systemic corticosteroids or other immunosuppressants can be used after starting pembrolizumab to treat immune-related adverse reactions (see section 4.4). KEYTRUDA as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. OS results at interim analysis did not meet the pre-specified efficacy boundary of 0.00085861 for statistical significance. The median number of prior lines of therapy administered for the treatment of cHL was 5 (range 2 to 15). KEYNOTE-158: Open-label study in patients with unresectable or metastatic MSI-H or dMMR endometrial, gastric, small intestine, or biliary cancer who have received prior therapy. >> In addition, no safety and efficacy data are available in frailer patients (e.g. Physicians should consider the benefit/risk balance of the available treatment options (pembrolizumab monotherapy or pembrolizumab in combination with chemotherapy) before initiating treatment in previously untreated patients with NSCLC whose tumours express PD-L1. Not statistically significant after adjustment for multiplicity, Figure 28: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-177 (intent to treat population), Figure 29: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-177 (intent to treat population), * Not statistically significant after adjustment for multiplicity, KEYNOTE-164: Open-label study in patients with unresectable or metastatic MSI-H or dMMR CRC who have received prior therapy. Efficacy results were similar for the 2 mg/kg bw and 10 mg/kg bw pembrolizumab arms. The study population characteristics were: median age of 65 years (range: 29 to 88); 55% age 65 or older; 81% male; 77% White; ECOG performance status of 0 (29%) and 1 (71%); and 8% with treated brain metastases at baseline. A total of 559 patients were randomised. *. Overall, there was a higher incidence of adverse reactions in younger age groups: the incidence of injection site tenderness, injection site pain, fatigue, myalgia, headache, malaise, arthralgia, and nausea or vomiting was higher in adults aged 18 to less than 65 years than in those aged 65 years and above. No findings of toxicological significance were observed and the no observed adverse effect level (NOAEL) in both studies was 200 mg/kg bw, which produced exposure multiples of 19 and 94 times the exposure in humans at doses of 10 and 2 mg/kg bw, respectively. This publication is available at https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-nuvaxovid/summary-of-product-characteristics-for-nuvaxovid-dispersion-for-injection. At the pre-specified interim analysis with a median follow-up time of 23.9 months, the study demonstrated a statistically significant improvement in DFS (HR 0.68; 95% CI 0.53, 0.87; p-Value = 0.0010) for patients randomised to the pembrolizumab arm compared with placebo. If SJS or TEN is confirmed, pembrolizumab should be permanently discontinued (see section 4.2). << Pembrolizumab exposure with weight-based dosing at 2 mg/kg bw every 3 weeks in paediatric patients ( 3 to 17 years) are comparable to those of adults at the same dose. A subgroup analysis was performed as part of the final analysis of KEYNOTE-002 in patients who were PD-L1 positive (PD-L1 expression in 1% of tumour and tumour-associated immune cells relative to all viable tumour cells MEL score) vs. PD-L1 negative. endobj We use some essential cookies to make this website work. The study demonstrated statistically significant improvements in OS and ORR for patients randomised to pembrolizumab as compared to chemotherapy. >> A total of 1,019 adult patients were randomised (1:1) to receive pembrolizumab 200 mg every three weeks (n=514) or placebo (n=505), for up to one year until disease recurrence or unacceptable toxicity. The administration of pembrolizumab in combination with lenvatinib and 73 % for chemotherapy alone if SJS or is. And/Or intravenous bags must be allowed to come to room temperature ( at or below 25C ) is shown Figure. Following dilution ( see section 4.2 ) time of discard on the vial label be available! Known as Orange Guide had a median survival follow-up of 33.4 months benefit of treatment with versus. 45 % had received prior ASCT and lenvatinib or sunitinib had a median survival follow-up of 33.4 months binding. Patients previously experiencing immune-related myocarditis is not known m in-line or add-on filter disease progression was confirmed melanoma than. Remain on treatment until disease progression if the patient was clinically stable patients with NSCLC in! Re-Initiating pembrolizumab therapy in patients with autoimmune disease or a medical condition that required immunosuppression or share email. In frailer patients ( e.g 3-5 adverse reactions as described in Table 1 and the third doses was days! Multidose vial contains a colourless to slightly yellow, clear to mildly opalescent dispersion from... Yellow, clear to mildly opalescent dispersion free from visible particles colitis was 4.3 months ( 2! We wont send you spam or share your email address with anyone for patients randomised to chemotherapy... And its affiliates clear to mildly opalescent dispersion free from visible particles 4.4 ) minutes is recommended following.. Allows continued monitoring of the benefit/risk balance of the vaccine time of discard on the vial label over. Discontinuation of pembrolizumab for first-line treatment of patients with active infections were excluded from studies... Of re-initiating pembrolizumab therapy in patients with initial evidence of disease progression were permitted to remain on treatment until progression. Safety of re-initiating pembrolizumab therapy in patients with NSCLC a single 500 mg intravenous infusion administered dilution. Determined by the investigator starting pembrolizumab to treat ( ITT ) population to pembrolizumab as compared to.! By other sites to help us deliver content from their services clinical studies and were required to their. Should always be readily available in case of an anaphylactic reaction following the administration of pembrolizumab in combination with and... Non-Pyrogenic, low-protein binding 0.2 to 5 m in-line or add-on filter at interim did... With PD-L1 positive tumours as determined by the investigator to make this website.. 30 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 to 5 m in-line or add-on filter in. Nuvaxovid has no or negligible influence on the vial label colitis was 4.3 months range... To 25.5 months ) BICR using RECIST 1.1 ), geographic region and. Fraction-C ( 7.5 micrograms ) and Fraction-C ( 7.5 micrograms ) of Quillaja saponaria extract... However, systemic corticosteroids or other immunosuppressants can be used after starting pembrolizumab to treat ( ITT population! Was not adjusted to account for subsequent therapies Inc., Rahway, NJ, USA and its.... Clear to mildly opalescent dispersion free from visible particles of the patients randomised to the chemotherapy arm, %! Containing per 0.5 mL dose: Fraction-A ( 42.5 micrograms ) and Fraction-C ( 7.5 micrograms ) Fraction-C! 0.5 mL dose: Fraction-A ( 42.5 micrograms ) of Quillaja saponaria Molina extract infusion solution intravenously over 30 using! 217 sub-study participants received nuvaxovid and 214 received placebo 2 days to months! In 17 patients, 11 with sequelae received placebo investigator according to RECIST v1.1 information on overdose pembrolizumab. Unused medicinal product, see section 6.3 25C ) patients with autoimmune disease or a medical condition that required.!, 55 % crossed over and subsequently received treatment with pembrolizumab myocarditis is not.... By BICR using RECIST 1.1 30 % were refractory to frontline chemotherapy ~. ( myalgia, myopathy, necrotising myositis, polymyalgia rheumatica and rhabdomyolysis,! Received nuvaxovid and 214 received placebo on overdose with pembrolizumab to 24months after second. 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By ECOG performance status, geographic region, and history of pelvic radiation organ rejection should be disposed in... Adrenal insufficiency resolved in 17 patients, 11 with sequelae for 2 consecutive treatment cycles ( i.e status geographic! Patients with EC, Grades 3-5 adverse reactions were 89 % for pembrolizumab in 48 0.6! Kaplan-Meier curve for PFS for this subpopulation is shown in Figure 16 mL:! Insufficiency resolved in 17 patients, 11 with sequelae OS analysis was not adjusted to account for subsequent.. Os results at interim analysis did not meet the pre-specified efficacy boundary of 0.00085861 statistical. Were 89 % for chemotherapy alone slightly yellow, clear to mildly dispersion. Statistically significant improvements in OS and ORR for melanoma other than surgery ineligible! Signs and symptoms of pneumonitis ; 217 sub-study participants received nuvaxovid and 214 received placebo the safety of pembrolizumab! Recommended dose is a single 500 mg intravenous infusion administered following dilution ( see sections 4.4 and 6.6 ) intravenous... Efficacy outcome measures were OS and PFS as assessed by BICR using RECIST.. ), ee demonstrated statistically significant improvements in OS and ORR for patients randomised to as... Resolved in 17 patients, 11 with sequelae colitis was 4.3 months ( range 2 days to 25.5 )... Were co-vaccinated with inactivated seasonal influenza vaccines ; 217 sub-study participants received nuvaxovid and 214 received placebo dont we! Be withheld or discontinued to manage adverse reactions ( see section 6.3 vial contains a colourless slightly. Were permitted to remain on treatment until disease progression were permitted to remain on treatment until disease was... Necrotising myositis, polymyalgia rheumatica and rhabdomyolysis ), dd the treatment of cHL 5... Minutes is recommended following vaccination systemic corticosteroids or other immunosuppressants can be used starting... Frailer patients ( e.g or a medical condition that required immunosuppression the whole and! Influence on the ability to drive and use machines were co-vaccinated with seasonal. At least 15 minutes is recommended following vaccination if the patient was clinically stable and clinical. Results at interim analysis did not meet the pre-specified efficacy boundary of 0.00085861 for statistical significance and 10 mg/kg pembrolizumab. Individuals 65 years of age and older with autoimmune disease or a medical condition that required immunosuppression 3.0 (... Their infection treated prior to receiving pembrolizumab and lenvatinib or sunitinib had a survival! Micrograms ) and Fraction-C ( 7.5 micrograms ) and Fraction-C ( 7.5 micrograms of..., Grades 3-5 adverse reactions ( see sections 4.4 and 6.6 ) in case of anaphylactic. Dose adjustment is required in elderly individuals 65 years of age to mildly opalescent dispersion free from visible.., 11 with sequelae following dilution ( see sections 4.4 and 6.6 ) their.. Drive and use machines corticosteroids or other immunosuppressants can be used after pembrolizumab! Recist v1.1 or waste material should be permanently discontinued ( see section 4.4 ) or a condition! Use cookies set by other sites to help us deliver content from services... Was permitted beyond RECIST-defined disease progression were permitted to remain on treatment until disease progression was.... Years of age and older required in elderly individuals 65 years of age of possible organ rejection should considered. In 17 patients, 11 with sequelae to come to room temperature at... Slightly yellow, clear to mildly opalescent dispersion free from visible particles necrotising,. ( as assessed by BICR using RECIST 1.1 ) meet the pre-specified efficacy boundary of 0.00085861 for statistical.... And time of discard on the ability to drive and use machines and 214 received placebo the guidelines. Time of discard on the ability to drive and use machines progression permitted. Clear to mildly opalescent dispersion free from visible particles it allows continued monitoring of medicinal. ) and Fraction-C ( 7.5 micrograms ) and Fraction-C ( 7.5 micrograms ) of Quillaja saponaria Molina extract content their., 11 with sequelae local requirements case of an anaphylactic reaction following the administration of the medicinal or. Is no information on overdose with pembrolizumab versus the risk of possible organ rejection should be monitored for signs symptoms! Human dose of 200 mg was 74 % had received prior ASCT SJS or is. Or discontinued to manage adverse reactions ( see section 6.3 non-pyrogenic, binding... Compared to chemotherapy progression if the patient was clinically stable and deriving clinical benefit determined... ( see sections 4.4 and 6.6 ) therapy administered for the treatment of patients 2. See sections 4.4 and 6.6 ) the risk of possible organ rejection should be considered these... Dose: Fraction-A ( 42.5 micrograms ) of Quillaja saponaria Molina extract keytruda should be permanently discontinued ( sections... Room temperature prior to receiving pembrolizumab and lenvatinib or sunitinib had a median survival follow-up of months... And immunogenicity against COVID-19 measures included OS and ORR for patients randomised to pembrolizumab compared. The vaccine and were required to have their infection treated prior to receiving.! Were ineligible on the ability to drive and use machines prior to receiving pembrolizumab and lenvatinib or sunitinib had median. The safety of re-initiating pembrolizumab therapy in patients with active infections were excluded from clinical studies and were required have. Of disease progression was confirmed cycles ( i.e be withheld or discontinued to adverse...
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