QRjj$HUwg Efficacy results in this subpopulation were consistent with the ITT population. Eighty-four percent had M1c stage and 8% of patients had a history of brain metastases. Among patients with BRAF mutant tumours, 10 (50%) were previously treated with a BRAF inhibitor. Refer to The SPC for full prescribing information 3.1 Bronchodilators 3.1.1 Adrenoreceptor agonists Short acting beta agonist (SABA . 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. The efficacy of pembrolizumab was investigated in KEYNOTE-177, a multicentre, randomised, open-label, active-controlled study that enrolled patients with previously untreated metastatic MSI-H or dMMR CRC. All patients received pembrolizumab for a median of 4 doses (range 1-35 doses), with 138 patients (85.7%) receiving pembrolizumab for 2 doses or more. BRAF mutations were reported in 13% of the study population. The primary efficacy outcome measure was PFS as assessed by blinded independent central review (BICR) using RECIST 1.1. Terms and Conditions Opens in new window | Privacy Notice Opens in new window, Click on this link to navigate to www.mhra.gov.uk, Good Manufacturing Practice (GMP) certificates, Good Distribution Practice Certificates (GDP). Alnylam B.V. Netherlands has obtained approval from the MHRA to supply German product (batch number 650313; batch size 280 packs), which is expected to be on the UK market . ?F}
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Dma;}@zqZ+/RwHrGr&iy3gMdyuDT@S0:n@BsRssHsVBT{{V!B Treatment could continue beyond disease progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. 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). 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. In patients with HNSCC treated with pembrolizumab as monotherapy (n=909), the incidence of hypothyroidism was 16.1% (all Grades) with 0.3% Grade 3. An HR=0.81 [95% CI 0.43, 1.55] in OS, an HR=0.61 [95% CI 0.34, 1.09] in PFS, and an ORR of 62% and 45% for pembrolizumab combination vs. chemotherapy was reported within this study subgroup. Pneumonitis has been reported in patients receiving pembrolizumab (see section 4.8). >> Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs). All prescribers of KEYTRUDA must be familiar with the Physician Information and Management Guidelines. The following factors had no clinically important effect on the clearance of pembrolizumab: age (range 15-94 years), gender, race, mild or moderate renal impairment, mild or moderate hepatic impairment and tumour burden. Treatment continued until unacceptable toxicity or disease progression as determined by the investigator and confirmed by BICR using RECIST 1.1. Assessment of tumour status was performed at 12 weeks, then every 6 weeks through Week 48, followed by every 12 weeks thereafter. Demographic characteristics were similar among participants who received Nuvaxovid and those who received placebo. Response was assessed in KEYNOTE-087 and KEYNOTE-013 every 12 and 8 weeks, respectively, with the first planned post-baseline assessment at Week 12. Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and participants who received placebo. << << The study demonstrated a statistically significant improvement in OS for patients whose tumours expressed PD-L1 TPS 1% randomised to pembrolizumab monotherapy compared to chemotherapy (HR 0.82; 95% CI 0.71, 0.93 at the final analysis) and in patients whose tumours expressed PD-L1 TPS 50% randomised to pembrolizumab monotherapy compared to chemotherapy. Paclitaxel 175 mg/m2 + carboplatin AUC 5 mg/mL/min + bevacizumab 15 mg/kg. HWS6_Hb,GKBLg;Nmva~i?~>Fvq59>LDz1b'~:
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9c(|2(?f`o$8H,$4E<>sQQvAck2eShaEx:o`lP7r4kDqk2E9adV&! Full form of MHRA is Medicines and Healthcare products Regulatory Agency. << /Length 29 0 R Table 40 summarises key efficacy measures from the pre-specified analyses. Clinical particulars 4.1 Therapeutic indications 4.2 Posology and method of administration 4.3 Contraindications 4.4 Special warnings and precautions for use 4.5 Interaction with other medicinal products and other forms of interaction Secondary efficacy outcome measures were OS and ORR (as assessed by BICR using RECIST 1.1). The median time to onset of nephritis was 4.2 months (range 12 days to 21.4 months). Table 42: Efficacy results in KEYNOTE-775,
This includes information of a commercially sensitive or personal nature, that may need to be restricted in the interests of security. The median area under the concentration time curve at steady-state over 3 weeks (AUC0-3weeks) was 794 mcgday/mL at a dose of 2 mg/kg bw every 3 weeks and 1,053 mcgday/mL at a dose of 200 mg every 3 weeks. The recommended dose of KEYTRUDA in adults is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes. 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. These results indicate a potential risk, based on its mechanism of action, that administration of pembrolizumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth. For the neoadjuvant and adjuvant treatment of TNBC, patients should be treated with neoadjuvant KEYTRUDA in combination with chemotherapy for 8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity, followed by adjuvant treatment with KEYTRUDA as monotherapy for 9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks or until disease recurrence or unacceptable toxicity. Women of childbearing potential should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab. # From product-limit (Kaplan-Meier) method for censored data, Figure 34: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-355 patients with PD-L1 expression (CPS 10), Figure 35: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-355 patients with PD-L1 expression (CPS 10), KEYNOTE-775: Controlled study of combination therapy in advanced EC patients previously treated with systemic chemotherapy. /Rotate 0
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. Pneumonitis resolved in 190 patients, 6 with sequelae. See MHRA Guidance Mar 2018: Valproate use by women and girls and MHRA Valproate Pregnancy Prevention Programme toolkit for full details. Safety data of pembrolizumab in the adjuvant melanoma setting in patients 75 years are limited. Thyroid function and hormone levels should be monitored to ensure appropriate hormone replacement. Based on stratified log-rank test (compared to an alpha boundary of 0.00549),
There was no evidence of an altered pharmacokinetic or safety profile with anti-pembrolizumab binding or neutralising antibody development. Table 34: Efficacy results in KEYNOTE-581 by MSKCC prognostic group, * Median follow-up: 26.5 months (data cutoff 28 August 2020),
Based on the severity of the adverse reaction, pembrolizumab should be withheld and corticosteroids administered. /ModDate (D:20190624094123+01'00') Among patients with BRAF mutant tumours, 139 (46%) were previously treated with a BRAF inhibitor. Patients without disease progression were treated for up to 24 months (up to 35 cycles). The safety and efficacy of pembrolizumab were investigated in KEYNOTE-006, a multicentre, open-label, controlled, Phase III study for the treatment of advanced melanoma in patients who were nave to ipilimumab. Secondary efficacy outcome measures included response duration, PFS, and OS. Human immunoglobulins G4 (IgG4) are known to cross the placental barrier; therefore, being an IgG4, pembrolizumab has the potential to be transmitted from the mother to the developing foetus. Hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids.
/Parent 3 0 R << If specified in the indication, patient selection for treatment with KEYTRUDA based on MSI-H/dMMR tumour status should be confirmed by a validated test (see sections 4.1 and 5.1). The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. what are you looking for? Paclitaxel 175 mg/m2 + cisplatin 50 mg/m2, 2. Efficacy results are summarised in Table 38. 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. Participants will be followed for up to 24months after the second dose for assessments of safety, efficacy, and immunogenicity against COVID-19. The median follow-up time in months was 37.3 (range: 0.1 to 65.2). Nephritis resolved in 20 patients, 5 with sequelae. KEYNOTE-826: Controlled study of combination therapy in patients with persistent, recurrent, or metastatic cervical cancer. The study excluded patients with autoimmune disease or a medical condition that required immunosuppression. This is a description of a medicinal products properties and the conditions attached to its use. A total of 1,173 participants (PP-IMM Analysis Set) received a booster dose of Nuvaxovid approximately 6months after completion of the primary series of Nuvaxovid (Day201). The baseline characteristics of these 383 patients were: median age of 63 years (range: 28 to 89), 41% age 65 or older; 82% male; 34% White and 56% Asian; 43% and 57% had an ECOG performance status of 0 and 1, respectively. Patients with active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible. /Contents 21 0 R Efficacy in Adolescents 12 through 17 years of age. 0086 136 9073 4191. domogres@spcfloorings.net. A secondary efficacy outcome measure was OS. 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. (see section 4.8). 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. The median follow-up time in months was 21.9 (range: 1.5 to 64.0) for endometrial, 13.9 (range: 1.1 to 66.9) for gastric, 29.1 (4.2 to 67.7) for small intestine, and 19.4 (range: 1.1 to 60.8) for biliary cancer. An analysis was performed in KEYNOTE-189 in patients who had PD-L1 TPS < 1% [pembrolizumab combination: n=127 (31%) vs. chemotherapy: n=63 (31%)], TPS 1-49% [pembrolizumab combination: n=128 (31%) vs. chemotherapy: n=58 (28%)] or 50% [pembrolizumab combination: n=132 (32%) vs. chemotherapy: n=70 (34%)] (see Table 15). Enrolment was completed in November 2020. , 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. Dont worry we wont send you spam or share your email address with anyone. Disease characteristics were: 21% HPV positive and 95% had stage IV disease (stage IVa 21%, stage IVb 6%, and stage IVc 69%). Secondary efficacy outcome measures were duration of response, PFS, and OS. The primary efficacy outcome measures were OS and PFS (as assessed by BICR using RECIST 1.1). KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1). Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. Adrenal insufficiency (primary and secondary) has been reported in patients receiving pembrolizumab. Assessment of tumour status was performed every 9 weeks for the first 45 weeks, and every 12 weeks thereafter. 13 0 obj In Study 3, an ongoing Phase 2a/b randomizsed, observer-blinded, placebo-controlled study, the safety and immunogenicity of booster dose was evaluated in healthy HIV-negative adult participants 18 to 84years of age and medically stable PLWH 18 to 64years of age who were seronegative to SARS-CoV-2 at baseline. 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. Table 34 summarises the efficacy measures by MSKCC prognostic group from the pre-specified primary analysis and the updated OS analysis. Updated to add product information about the Moderna (Spikevax) Original/Omicron BA.4/5 vaccine. Dont include personal or financial information like your National Insurance number or credit card details. Paclitaxel 175 mg/m2 + cisplatin 50 mg/m2 + bevacizumab 15 mg/kg, 3. 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).. * Hazard ratio (pembrolizumab compared to chemotherapy) based on the stratified Cox proportional hazard model, Not statistically significant after adjustment for multiplicity, Based on patients with a best objective response as confirmed complete or partial response from the final analysis, Figure 3: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-002 (intent to treat population), KEYNOTE-001: Open-label study in melanoma patients nave and previously treated with ipilimumab. Translucent to white proteinaceous particles may be seen in diluted solution. Liver enzymes should be monitored before initiation of and periodically throughout treatment. It is unknown whether Nuvaxovid is excreted in human milk. Tickets cost 17 - 25 and the journey . Eighty-seven percent of patients had visceral metastases, including 34% with liver metastases. It is used by healthcare professionals, such as doctors, nurses and pharmacists. For the full list of excipients, see section 6.1. /Filter /FlateDecode Factors associated with early deaths were fast progressive disease on prior platinum therapy and liver metastases. At a pre-specified interim analysis, the median follow-up time for all patients was 37.8 months (range: 2.7-48 months). 09 / 22. Patients were randomised (2:1) to receive either pembrolizumab or placebo via intravenous infusion: o Four cycles of neoadjuvant pembrolizumab 200 mg every 3 weeks or placebo on Day 1 of cycles 1-4 of treatment regimen in combination with: AUC 5 mg/mL/min every 3 weeks on Day 1 of cycles 1-4 of treatment regimen or AUC 1.5 mg/mL/min every week on Day 1, 8, and 15 of cycles 1-4 of treatment regimen and, Paclitaxel 80 mg/m2 every week on Day 1, 8, and 15 of cycles 1-4 of treatment regimen. In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted. This updated OS analysis was not adjusted to account for subsequent therapies. 6472 Randomisation was stratified by tumour PD-L1 expression (TPS < 1% [negative] vs. TPS 1%), investigator's choice of paclitaxel or nab-paclitaxel, and geographic region (East Asia vs. non-East Asia). Table 5 summarises key efficacy measures in patients previously treated or nave to treatment with ipilimumab, receiving pembrolizumab at a dose of 2 mg/kg bw based on a minimum follow-up time of 30 months for all patients. The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials. The potential risk of gastrointestinal perforation should be taken into consideration. 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Table 40 summarises key efficacy measures by MSKCC prognostic group from the pre-specified primary analysis and the updated analysis. Independent central review ( BICR ) using RECIST 1.1 response was assessed in KEYNOTE-087 and KEYNOTE-013 12... Insurance number or credit card details: 2.7-48 months ) Controlled study of therapy! Had a history of brain metastases 10 ( 50 % ) were previously treated with a BRAF.! ( primary and secondary ) has been reported in patients with autoimmune disease or a medical condition that required or! Ocular melanoma were ineligible melanoma were ineligible spam or share your email address with anyone that...