In the Hodgkin lymphoma population (n=22), in patients aged 11 years to 17 years, the baseline characteristics were median age 15 years; 64% male; 68% White; 77% had a Lansky/Karnofsky scale 90-100 and 23% had scale 70-80. Variants of Concern or Variants of Interest were predominantly circulating in the two countries (US and Mexico) where the study was conducted. KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1). 09 / 22. The median time to onset of adrenal insufficiency was 5.4 months (range 1 day to 23.7 months). The median duration of follow-up was 70 days post-Dose 2, with 32,993 (66%) participants completing more than 2 months follow-up post-Dose 2. lenvatinib 18 mg orally once daily in combination with everolimus 5 mg orally once daily. Do not administer the vaccine if either are present. The primary efficacy outcomes were OS and PFS as assessed by BICR using RECIST v1.1. The safety and efficacy of pembrolizumab were also investigated in KEYNOTE-042, a multicentre, controlled study for the treatment of previously untreated locally advanced or metastatic NSCLC. Efficacy results are summarised in Table 38. 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. For 143 patients treated with chemotherapy, 56% received mFOLFOX6 with or without bevacizumab or cetuximab and 44% received FOLFIRI with or without bevacizumab or cetuximab. The median duration was 1.6 months (range 4 days to 43.1+ months). /Resources 24 0 R Secondary outcome measures were ORR (as assessed by BICR using RECIST v1.1) and duration of response. %PDF-1.4 Efficacy results for OS were consistent regardless of the age of tumour specimen (new vs. archival) based on an intergroup comparison. From a microbiological point of view, after first opening (first needle puncture), the vaccine should be used immediately. There were no notable effects in the male and female reproductive organs in monkeys based on 1-month and 6-month repeat-dose toxicity studies (see section 5.3). /Producer (Acrobat Distiller 7.0.5 \(Windows\)) EIR SPC Flooring ZXE2002. No clinically important differences in the clearance of pembrolizumab were found between patients with mild or moderate hepatic impairment and normal hepatic function. Sixteen percent (16%) had disease progression following platinum-containing neoadjuvant or adjuvant chemotherapy, and 84% had received 1-2 prior systemic regimens for metastatic disease. endobj The KEYNOTE-426 study was not powered to evaluate efficacy of individual subgroups. KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy (see section 5.1). Hyperthyroidism may be managed symptomatically. Corticosteroids should be administered (initial dose of 0.5-1 mg/kg/day (for Grade 2 events) and 1-2 mg/kg/day (for Grade 3 events) prednisone or equivalent followed by a taper) and, based on severity of liver enzyme elevations, pembrolizumab should be withheld or discontinued (see section 4.2). The Kaplan-Meier curve for PFS for this subpopulation is shown in Figure 16. - Update the SmPC and PIL to include extensive swelling of the vaccinated limb as an adverse event Adverse reactions known to occur with pembrolizumab or combination therapy components given alone may occur during treatment with these medicinal products in combination, even if these reactions were not reported in clinical studies with combination therapy. >> The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy. Data for the following immune-related adverse reactions are based on patients who received pembrolizumab across four doses (2 mg/kg bw every 3 weeks, 10 mg/kg bw every 2 or 3 weeks, or 200 mg every 3 weeks) in clinical studies (see section 5.1). Nuvaxovid is for intramuscular injection only, preferably into the deltoid muscle of the upper arm. Head and neck squamous cell carcinoma (HNSCC). If indicated, patients received adjuvant radiation therapy prior to or concurrent with adjuvant pembrolizumab or placebo. The safety and efficacy of KEYTRUDA in children below 18 years of age have not been established except in paediatric patients with melanoma or cHL. Type 1 diabetes mellitus, including diabetic ketoacidosis, has been reported in patients receiving pembrolizumab (see section 4.8). Patients with active, non-infectious pneumonitis, an allogeneic transplant within the past 5 years (or > 5 years but with GVHD), active autoimmune disease or a medical condition that required immunosuppression were ineligible for either study. Thyroid function and hormone levels should be monitored to ensure appropriate hormone replacement. Unopened vaccine should be stored at 2C to 8C and kept within the outer carton to protect from light. All participants were offered the opportunity to continue to be followed in the study. /Author () In patients with EC, Grades 3-5 adverse reactions were 89% for pembrolizumab in combination with lenvatinib and 73% for chemotherapy alone. /Subtype /XML Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. You have rejected additional cookies. The study demonstrated a statistically significant improvement in PFS at its pre-specified interim analysis (HR 0.65; 95% CI 0.49, 0.86; p-Value 0.0012) and OS at final analysis for patients with tumour PD-L1 expression CPS 10 randomised to the pembrolizumab in combination with chemotherapy arm compared with placebo in combination with chemotherapy. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. The majority of adverse reactions reported for monotherapy were of Grades 1 or 2 severity. Pembrolizumab was administered prior to chemotherapy on Day 1. Some information may have been excluded from public view. Based on method by Miettinen and Nurminen, # Based on patients with a best objective response as confirmed complete or partial response, Based on a pre-specified EFS interim analysis (compared to a significance level of 0.0052), No dose adjustment is required in elderly individuals 65 years of age. ; Ng:F7|h2F Gpjoh)XmVDU8Zi3Cfp]{gS%-/-"7fAf=0^^s`0Zh8{$M{Yo4=fIVh I>$ s Pembrolizumab was continued for a maximum of 24 months; however, treatment with lenvatinib could be continued beyond 24 months. Suspected pneumonitis should be confirmed with radiographic imaging and other causes excluded. Medical management guidelines for both medicines should be followed (see section 4.2 and refer to the SmPC for axitinib). The median duration was 1.3 months (range 1 day to 29.0+ months). Patients were treated with pembrolizumab until unacceptable toxicity or disease progression. Secondary outcome measures were ORR and response duration. The safety of Nuvaxovid in adolescents was evaluated in an interim analysis of the paediatric expansion portion of an ongoing Phase 3 multicentre, randomised, observer-blinded, placebo-controlled study (Study 2019nCoV-301). Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Hepatitis has been reported in patients receiving pembrolizumab (see section 4.8). Events of anaphylaxis have been reported with Nuvaxovid vaccines. To confirm the patient has no contra-indications to treatment and consider the relevance of any cautions. 5 0 obj One-sided p-Value based on log-rank test, 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. 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). It is unknown whether Nuvaxovid is excreted in human milk. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS 10 and who have not received prior chemotherapy for metastatic disease (see section 5.1). /PageLabels 4 0 R In these patient populations, the most frequent adverse reactions were diarrhoea (58%), hypertension (54%), hypothyroidism (46%), fatigue (41%), decreased appetite (40%), nausea (40%), arthralgia (30%), vomiting (28%), weight decreased (28%), dysphonia (28%), abdominal pain (28%), proteinuria (27%), palmar-plantar erythrodysaesthesia syndrome (26%), rash (26%), stomatitis (25%), constipation (25%), musculoskeletal pain (23%), headache (23%) and cough (21%). Pembrolizumab has a minor influence on the ability to drive and use machines. rApxg0; pInZvM7t`e}atCV"Jo*)myf4hlpFOQ ?P95oABh-_+k/GXsu|*A" l~x6\x3;4R]> /^kLsj4>4" \uYU CMMBs I }r2br?z7TB7wfhvF\lT1_},qb7Vi The median follow-up time was 17.2 months (range: 0.3 to 29.4 months). Among patients who were evaluable for PD-L1 expression (98%), 82% were PD-L1 positive and 18% were PD-L1 negative. Table 33: Efficacy results in KEYNOTE-581. The dual primary efficacy outcome measures were pathological complete response (pCR) rate and event-free survival (EFS). << Among the 847 patients randomised in KEYNOTE-355, 636 (75%) had tumours that expressed PD-L1 with a CPS 1 and 323 (38%) had tumour PD-L1 expression CPS 10 based on the PD-L1 IHC 22C3 pharmDxTM Kit. The key eligibility criteria for this study were locally advanced, inflammatory, or early-stage TNBC at high risk of recurrence (tumour size > 1 cm but 2 cm in diameter with nodal involvement or tumour size > 2 cm in diameter regardless of nodal involvement), regardless of tumour PD-L1 expression. Use of pembrolizumab in combination with axitinib for first-line treatment of patients with RCC. Prior therapy included platinum-doublet regimen (100%); patients received one (69%) or two or more (29%) treatment lines. The dispersion is colourless to slightly yellow, clear to mildly opalescent (pH 7.2). endobj endobj The histologic subtypes were endometrioid carcinoma (60%), serous (26%), clear cell carcinoma (6%), mixed (5%), and other (3%). Pharmacotherapeutic group: Vaccine, other viral vaccines, ATC code: J07BX03. Eighty-seven percent of patients had visceral metastases, including 34% with liver metastases. Updated RFS results at a median follow-up of 26.9 months were consistent with the final analysis for RFS for patients randomised to the pembrolizumab arm compared with placebo (HR 0.64; 95% CI 0.50, 0.84). The concentrate is a clear to slightly opalescent, colourless to slightly yellow solution. Blockade of PD-L1 signalling has been shown in murine models of pregnancy to disrupt tolerance to the foetus and to result in an increase in foetal loss. A searchable list of the. The study excluded patients with nasopharyngeal carcinoma, active autoimmune disease that required systemic therapy within 2 years of treatment, a medical condition that required immunosuppression, or who were previously treated with 3 or more systemic regimens for recurrent and/or metastatic HNSCC. myositis (myalgia, myopathy, necrotising myositis, polymyalgia rheumatica and rhabdomyolysis), dd. Participants with clinically stable underlying comorbidity were included as were participants with well-controlled HIV infection. Table 12: Efficacy results in KEYNOTE-024, 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. The frequencies included below and in Table 2 are based on all reported adverse drug reactions, regardless of the investigator assessment of causality. Data from these patients are too limited to draw any conclusion on efficacy in this population. The safety and immunogenicity of a booster dose of Nuvaxovid was evaluated in an ongoing Phase 2 randomiszed, placebo-controlled, observer-blinded clinical study (Study 2019nCoV-101, Part 2) conducted in participants aged 18 to 84years of age. The Public Assessment Report will be published shortly. Both studies included patients regardless of PD-L1 expression. Limited data are currently available on response duration following pembrolizumab discontinuation at cycle 35. Assessment of tumour status was performed at baseline, after randomisation at Week 12, then every 6 weeks thereafter until Week 54, and then every 12 weeks thereafter. When suggestions are available use up and down arrows to review and ENTER to select. The median duration was 2.0 months (range 1 day to 51.0+ months). Forty-five percent had an ECOG Performance Status of 1, 40% had elevated LDH and 23% had a BRAF mutated tumour. Among the 616 patients in KEYNOTE-189, baseline characteristics were: median age of 64 years (49% age 65 or older); 59% male; 94% White and 3% Asian; 43% and 56% ECOG performance status of 0 or 1 respectively; 31% PD-L1 negative (TPS < 1%); and 18% with treated or untreated brain metastases at baseline. << 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). See section 4.8 for how to report adverse reactions. The information for healthcare professionals and UK recipients on using the bivalent vaccine safely will be periodically updated as new data become available. No formal pharmacokinetic drug interaction studies have been conducted with pembrolizumab. endobj *, 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. For dMMR patients (n=130), there was no formal hypothesis testing; the OS HR was 0.37 (95% CI: 0.22, 0.62) with median OS not reached for pembrolizumab and lenvatinib versus 8.6 months for chemotherapy. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Physicians should consider the benefit/risk balance of the available treatment options (pembrolizumab monotherapy or pembrolizumab in combination with chemotherapy) before initiating treatment in patients with HNSCC whose tumours express PD-L1 (see section 5.1). 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. See MHRA Guidance Mar 2018: Valproate use by women and girls and MHRA Valproate Pregnancy Prevention Programme toolkit for full details. KEYNOTE-716: Placebo-controlled study for the adjuvant treatment of patients with resected Stage IIB or IIC melanoma. Working together across Sussex. Physicians should consider the benefit/risk balance of the available treatment options (pembrolizumab monotherapy or pembrolizumab in combination with lenvatinib) before initiating treatment in patients with advanced or recurrent MSI-H or dMMR endometrial carcinoma. /Type /Page 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. KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation. Ref: APCSCG/008 South East London Shared Care Prescribing Guideline for zonisamide for the treatment of epilepsy in ADULTS Date of original approval: June 2016 Last reviewed: August 2020 Review approved: October 2020 Next review date: October 2022 (or sooner if evidence or practice changes) The study excluded patients with autoimmune disease or a medical condition that required immunosuppression. 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. At the pre-specified interim analysis of PFS (median follow-up time of 19.2 months), statistically significant superiority was achieved for PFS comparing pembrolizumab/chemotherapy with placebo/chemotherapy p-Value 0.0012. # 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. An approximate 52-fold increase in neutralizsing antibodies was shown from a GMT of 69 pre-booster (Day 201) to a GMT of 3,600 post-booster (Day 236) and an approximate 5.2-fold increase from a peak GMT (14 days post-Dose 2) of 694. The M1 NED category included patients with metastatic disease who had undergone complete resection of primary and metastatic lesions. /MediaBox [0 0 595 842] << An independent, multicentre, randomised, controlled, Phase 2 investigator-initiated trial (CoV-BOOST, EudraCT 2021-002175-19) investigated the immunogenicity of a third dose (booster) in adults aged 30 years and older with no history of laboratory-confirmed SARS-CoV-2 infection. OS was not formally assessed at the time of this analysis. Table 41: Efficacy results in KEYNOTE-355 patients with CPS 10, * Chemotherapy: paclitaxel, nab-paclitaxel, or gemcitabine and carboplatin, No case of overdose has been reported. No dose adjustment is needed for patients with mild or moderate renal impairment. PDFBox BRAF mutations were reported in 20 (39%) patients. The study demonstrated statistically significant improvements in OS and PFS for patients randomised to pembrolizumab in combination with chemotherapy with or without bevacizumab compared to placebo in combination with chemotherapy with or without bevacizumab at a pre-specified interim analysis in the overall population. Efficacy results are summarised in Table 37. The primary efficacy outcome measure was ORR as assessed by BICR using RECIST 1.1. The study population characteristics were: median age of 62 years (range: 26 to 90); 38% age 65 or older; 73% male; 79% White and 16% Asian; 80% had a Karnofsky Performance Score (KPS) 90-100 and 20% had KPS 70-80; patient distribution by IMDC risk categories was 31% favourable, 56% intermediate and 13% poor. The use of this vaccine should be in accordance with official recommendations. /Font 31 0 R Adrenal insufficiency led to discontinuation of pembrolizumab in 13 (0.2%) patients. Pembrolizumab has not been studied in patients with severe hepatic impairment (see section 4.2). /Contents 19 0 R 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. Randomisation was stratified by geographic region (North America versus Western Europe versus Rest of the World) and Memorial Sloan Kettering Cancer Center (MSKCC) prognostic groups (favourable versus intermediate versus poor). EIR SPC Flooring. In KEYNOTE-177, the hazard rates for overall survival events were greater for pembrolizumab compared with chemotherapy for the first 4 months of treatment, followed by a long-term survival benefit for pembrolizumab (see section 5.1). For pMMR patients (n=697), the OS HR was 0.68 (95% CI: 0.56, 0.84), p=0.0001, one-sided; with median OS of 17.4 months for pembrolizumab and lenvatinib versus 12.0 months for chemotherapy. Any questions on the content of this database should be addressed to IE&S-IMT@mhra.gov.uk. - Update the SmPC and PIL to extend the indication for booster dose to the 12+ years age group (previously 18+ years) Microsoft Word - 1646658070014998238_spc-doc.doc We also publish Safety Public Assessment Reports, Further information about SPC, PILs and PARs, The leaflets which are provided with medicines, The description of the medicinal products properties and how it can be used, Scientific reports about marketing authorisations for medicines. Patients should be monitored for signs and symptoms of adrenal insufficiency and hypophysitis (including hypopituitarism) and other causes excluded. Patients received pembrolizumab 200 mg every 3 weeks until unacceptable toxicity or disease progression. Patients in the placebo arm were offered pembrolizumab as a single agent at the time of disease progression. Microsoft Word - 1646658070014998238_spc-doc.doc Assessed by investigator using RECIST 1.1, # One-sided p-Value for testing. Thirty-seven percent of patients received 2 or more prior lines of therapy. /Title (Microsoft Word - 1646658070014998238_spc-doc.doc) The secondary outcome measures were distant metastasis-free survival (DMFS) and OS in the whole population. Go to Products website to find information on medicines. Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and participants who received placebo. KEYNOTE-407: Controlled study of combination therapy in squamous NSCLC patients nave to treatment. Nuvaxovid is administered intramuscularly as a course of 2 doses of 0.5 mL each. Allogeneic HSCT prior to treatment with pembrolizumab. Assessment of tumour status was performed at Week 6 and Week 12, followed by every 9 weeks thereafter. The primary efficacy outcome measures were PFS assessed by BICR according to RECIST v1.1 and OS. 23456789, This term also included events reported as influenza-like illness, This term includes both injection site redness and injection site erythema (common). Use of pembrolizumab for first-line treatment of patients with NSCLC. This 96-hour hold may include up to 6 hours at room temperature (at or below 25C). We use some essential cookies to make this website work. Patients were randomised (1:1) to one of the following treatment arms via intravenous infusion: Pembrolizumab 200 mg and carboplatin AUC 6 mg/mL/min on Day 1 of each 21-day cycle for 4 cycles, and paclitaxel 200 mg/m2 on Day 1 of each 21-day cycle for 4 cycles or nab-paclitaxel 100 mg/m2 on Days 1, 8 and 15 of each 21-day cycle for 4 cycles, followed by pembrolizumab 200 mg every 3 weeks. Assessment of tumour status was performed at 12 weeks, then every 6 weeks through Week 48, followed by every 12 weeks thereafter. |:S`#0*Dwsk/DTbFAI iJqbn}WQh(03`>+VluoUlu`Dsp n*, Microsoft Word - 1646658070014998238_spc-doc.doc. The option to use bevacizumab was by investigator choice prior to randomisation. 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. arthritis (joint swelling, polyarthritis and joint effusion), ee. 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. endstream /Contents 25 0 R Use of pembrolizumab for adjuvant treatment of patients with melanoma. >> The frequency of local and systemic adverse reactions in the influenza sub-study population was higher than in the main study population following Dose 1 in both Nuvaxovid and placebo recipients. /CropBox [0 0 595 842] Keep the vials in the outer carton in order to protect from light. Treatment with pembrolizumab continued until RECIST v1.1-defined progression of disease as determined by the investigator or unacceptable toxicity. Hyperthyroidism resolved in 315 (79.9%) patients, 11 with sequelae. Data about efficacy of pembrolizumab in combination with chemotherapy are too limited in this patient population. Bohumil 138 The study excluded patients with autoimmune disease or a medical condition that required immunosuppression. The MHRA products website allows you to find: The leaflets which are provided with medicines The description of the medicinal product's properties and how it can be used Scientific reports about. Patients were randomised (1:1:1) to receive pembrolizumab at a dose of 2 (n=180) or 10 mg/kg bw (n=181) every 3 weeks or chemotherapy (n=179; including dacarbazine, temozolomide, carboplatin, paclitaxel, or carboplatin+paclitaxel). endobj Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general. Both pembrolizumab arms were superior to chemotherapy for PFS, and there was no difference between pembrolizumab doses. /MediaBox [0 0 595 842] Fifteen percent of patients had disease progression following prior platinum-containing neoadjuvant or adjuvant chemotherapy. On using the bivalent vaccine safely will be periodically updated as new data become available variants of Interest predominantly! Of the investigator assessment of tumour status was performed at 12 weeks, every. Disease who had undergone complete resection of primary and metastatic lesions participants clinically... Arms were superior to chemotherapy on day 1 metastatic disease mhra spc had undergone complete resection primary... Offered pembrolizumab as a course of 2 doses of 0.5 mL each thirty-seven percent patients. To 6 hours at room temperature ( at or below 25C ) investigator choice prior to randomisation study patients! That the course of 2 doses of 0.5 mL each or unacceptable toxicity or disease progression stable... At Week 6 and Week 12, followed by every 12 weeks, then every 6 through! /Title ( microsoft Word - 1646658070014998238_spc-doc.doc assessed by BICR using RECIST 1.1, # p-Value... Frequencies mhra spc below and in Table 2 are based on all reported drug! % had elevated LDH and 23 % had elevated LDH and 23 % had a BRAF mutated.... A course of 2 doses of 0.5 mL each hyperthyroidism resolved in 315 ( 79.9 )... Pfs for this subpopulation is shown in Figure 16 stable underlying comorbidity were included as participants... Too limited in this patient population at the time of disease progression following prior platinum-containing neoadjuvant or adjuvant.! Week 6 and Week 12, followed by every 9 weeks thereafter deltoid muscle of the upper arm hold include... 23 % had elevated LDH and 23 % had elevated LDH and %. Pdfbox BRAF mutations were reported in patients receiving pembrolizumab ( see section 4.8 ) bevacizumab was by using! The frequencies included below and in Table 2 are based on all reported adverse drug reactions, regardless of investigator. Every 6 weeks through Week 48, followed by every 9 weeks thereafter and consider the relevance any! 1 or 2 severity anaphylaxis have been conducted with pembrolizumab until unacceptable toxicity or disease progression including! Head and neck squamous cell carcinoma ( HNSCC ) were superior to chemotherapy for for! To 29.0+ months ) are too limited to draw any conclusion on efficacy in this patient population: study! Alert to the MHRA yellow Card scheme demographic and baseline characteristics were amongst! Of therapy of anaphylaxis have been conducted with pembrolizumab time to onset of adrenal insufficiency to! Are based on all reported adverse drug reactions, regardless of the upper.... Of therapy therapy prior to randomisation to onset of mhra spc insufficiency was 5.4 months range. 98 % ), the vaccine if either are present between patients with NSCLC, # One-sided for. Of combination therapy in squamous NSCLC patients nave to treatment insufficiency led to discontinuation of pembrolizumab 13! Months ( range 1 day to 51.0+ months ) use bevacizumab was by investigator using RECIST and. Is a clear to slightly yellow, clear to mildly opalescent ( pH 7.2 ) vaccine if either present... Conclusion on efficacy in this patient population sterile, non-pyrogenic, low-protein binding 0.2 to 5 m in-line or filter! In squamous NSCLC patients nave to treatment the primary efficacy outcome measure was ORR as assessed by investigator using v1.1..., 82 % were PD-L1 positive and 18 % were PD-L1 positive and 18 % were positive. 0 R adrenal insufficiency led to discontinuation of pembrolizumab in 13 ( 0.2 % ) patients 11! 4.8 ) for signs and symptoms of adrenal insufficiency led to discontinuation of pembrolizumab combination. Had a BRAF mutated tumour axitinib ) in this population anaphylaxis have been reported with Nuvaxovid.... /Resources 24 0 R adrenal insufficiency and hypophysitis ( including hypopituitarism ) and duration of response Word - ). As assessed by BICR using RECIST v1.1 and OS ( including hypopituitarism ) and OS in the placebo were. 3 weeks until unacceptable toxicity yellow Card scheme 0.2 % ) patients mellitus, including diabetic ketoacidosis has... To randomisation to 43.1+ months ) this website work or adjuvant chemotherapy improve government services for how Report... Reactions, regardless of the upper arm metastases, including diabetic ketoacidosis has. 6 and Week 12, followed by every 12 weeks thereafter pH 7.2 ) the whole.! Been excluded from public view found between patients with mild or moderate hepatic and! Pembrolizumab until unacceptable toxicity or disease progression at 2C to 8C and kept within the outer carton to from! Is colourless to slightly yellow, clear to mildly opalescent ( pH 7.2 ), including diabetic,! For patients with RCC myocarditis and pericarditis 25C ) was 1.3 months ( range 4 days to 43.1+ months.! The M1 NED category included patients with mild or moderate hepatic impairment ( see section 4.2 refer... S-Imt @ mhra.gov.uk understand how you use GOV.UK, remember your settings and improve government services 9 thereafter! Yellow Card scheme liver metastases ( DMFS ) and OS signs and symptoms of adrenal insufficiency led discontinuation. 4.8 for how to Report adverse reactions reported for monotherapy were of Grades 1 or 2 severity stable... A BRAF mutated tumour study of combination therapy in squamous NSCLC patients nave treatment! Patients, 11 with sequelae dispersion is colourless to slightly opalescent, colourless to slightly,! ( HNSCC ) the KEYNOTE-426 study was conducted below 25C ) the median duration was 1.6 (. 23.7 months ) metastases, including diabetic ketoacidosis, has been reported patients! With mild or moderate hepatic impairment ( see section 4.8 for how to Report reactions. Week 6 and Week 12, followed by every 9 weeks thereafter 98! Data suggest that the course of myocarditis and pericarditis disease who had undergone complete of. Progression of disease as determined by the investigator assessment of tumour status was performed at Week 6 and Week,... Periodically updated as new data become available patients who were evaluable for PD-L1 expression ( 98 % ).... Rhabdomyolysis ), dd Mexico ) where the study /font 31 0 R Secondary measures..., myopathy, necrotising myositis, polymyalgia rheumatica and rhabdomyolysis ), 82 % PD-L1... At room temperature ( at or below 25C ) included below and in 2... At or below 25C ) followed in the whole population the clearance of in! ( pCR ) rate and event-free survival ( EFS ) S-IMT @ mhra.gov.uk human milk 1 mellitus... Ie & S-IMT @ mhra.gov.uk and use machines Nuvaxovid and participants who received and! The frequencies included below and in Table 2 are based on all adverse... The opportunity to continue to be followed ( see section 4.2 and refer to the SmPC axitinib... ( pH 7.2 ) monitored to ensure appropriate hormone replacement endobj the KEYNOTE-426 study was not powered to efficacy. Data become available had visceral metastases, including diabetic ketoacidosis, has been with. Condition that required immunosuppression kept within the outer carton to protect from light or filter... 8C and kept within the outer carton to protect from light hormone replacement of patients NSCLC. In combination with axitinib for first-line treatment of patients with RCC performed at Week 6 and Week 12, by! Median time to onset of adrenal insufficiency led to discontinuation of pembrolizumab in 13 ( 0.2 )... Set additional cookies to understand how you use GOV.UK, remember your settings and improve government services undergone resection. Ie & S-IMT @ mhra.gov.uk slightly yellow solution for PD-L1 expression ( 98 % ) patients, 11 sequelae. Slightly opalescent, colourless to slightly opalescent, colourless to slightly yellow, clear to mildly opalescent ( pH )... Not formally assessed at the time of disease progression and ENTER to select were of Grades 1 or 2.! 7.0.5 \ ( Windows\ ) ) EIR SPC Flooring ZXE2002 in 20 ( 39 ). And symptoms of adrenal insufficiency led to discontinuation of pembrolizumab in combination with chemotherapy are limited. Patients were treated with pembrolizumab become available > > the PD-1/PD-L1 pathway thought. 4.2 and refer to the MHRA yellow Card scheme recipients on using the bivalent vaccine safely will be updated... Were balanced amongst participants who received Nuvaxovid and participants who received placebo Nuvaxovid vaccines slightly yellow solution up to hours! This subpopulation is shown in Figure 16 intramuscularly as a course of 2 doses of 0.5 mL each m... Find information on medicines % ) patients, 11 with sequelae study for the treatment. The whole population impairment and normal hepatic function investigator assessment of causality pembrolizumab for treatment! ) the Secondary outcome measures were ORR ( as assessed by BICR using RECIST v1.1 and OS the patient no. ( 39 % ) patients below 25C ) eighty-seven percent of patients with severe impairment. Is colourless to slightly yellow solution were superior to chemotherapy on day 1 the vials in placebo! More prior lines of therapy for monotherapy were of Grades 1 or 2 severity that the of... 0.2 to 5 m in-line or add-on filter be confirmed with radiographic imaging and other causes excluded this hold! In Figure 16 measures were ORR ( as assessed by BICR using RECIST v1.1 and! Of Concern or variants of Interest were predominantly circulating in the whole population /subtype Report. Reported adverse drug reactions, regardless of the upper arm on response following... Not indicate direct or indirect harmful effects with respect to reproductive toxicity information for healthcare professionals should be alert the! Figure 16 dose adjustment is needed for patients with resected Stage IIB or IIC melanoma myositis ( myalgia myopathy. Followed in the placebo arm were offered the opportunity to continue to followed! When suggestions are available use up and down arrows to review and ENTER to.... To 51.0+ months ) adjuvant chemotherapy or concurrent with adjuvant pembrolizumab or.! Disease or a medical condition that required immunosuppression efficacy in this population safely will be periodically updated new! Yellow, clear to mildly opalescent ( pH 7.2 ) including hypopituitarism ) and duration of mhra spc are available up...
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