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FDA grants accelerated approval for GSK s JEMPERLI (dostarlimab-gxly) for women with recurrent or advanced dMMR endometrial cancer

Share this article Share this article LONDON, April 22, 2021 /PRNewswire/ GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved JEMPERLI (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody, based on the company s Biologics License Application. JEMPERLI is indicated for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that have progressed on or following prior treatment with a platinum-containing regimen. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

City ofUnited kingdomUnited statesUnited kingdom generalKathleen quinnJeff mclaughlinSimon steelSonya ghobrialPrnewswire glaxosmithklineMick readeyTim foleyJames dodwellHal barronKristen neeseDurham jn smithGynecologic oncology at levine cancer institute

U S Food and Drug Administration Approves Opdivo® in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma

U S Food and Drug Administration Approves Opdivo® in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma
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United statesSouth koreaYelenay janjigianBristol myers squibbAdam lenkowskyDrug administrationBristol myers squibb companyExchange commissionOno pharmaceutical coDrug administration approves opdivoMemorial sloan kettering cancer centerDrug administration approvesMetastatic gastric cancerGastroesophageal junction cancerEsophageal adenocarcinomaMyers squibb

Bristol Myers Squibb Receives European Commission Approval for Opdivo® in Combination with Cabometyx® as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma

Two Opdivo -based therapies are now authorized for first-line treatment of patients with advanced renal cell carcinoma in the European Union: Opdivo plus Yervoy in combination with Cabometyx Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo Cabometyx ® (cabozantinib) for the first-line treatment of adults with advanced renal cell carcinoma (RCC). The EC’s decision is based on results from the Phase 3 CheckMate -9ER trial, which demonstrated superior efficacy with Opdivo in combination with Cabometyx versus sunitinib across three key endpoints: progression-free survival (PFS), the primary endpoint, and objective response rate (ORR) and overall survival (OS). The combination of

United statesSouth koreaDana walkerMarc oliver grimmNina goworekBristol myers squibbRachel gilesCompany opdivoJena university hospitalBristol myers squibb companyTakeda pharmaceutical companyExelixis incEuropean unionEuropean commissionExchange commissionInternational kidney cancer coalition

Neoadjuvant Opdivo Plus Chemotherapy Significantly Improves Pathologic Complete Response in Patients with Resectable Non-Small Cell Lung Cancer in Phase 3 CheckMate -816 Trial

Nearly a quarter of patients who received Opdivo plus chemotherapy showed no evidence of cancer cells in tissue removed during surgery vs. 2.2% of patients who received chemotherapy alone Opdivo- based therapies have now demonstrated positive results in Phase 3 trials in earlier stages of four different types of cancer: non-small cell lung cancer, esophagealgastroesophageal junction cancer, bladder cancer and … Nearly a quarter of patients who received Opdivo plus chemotherapy showed no evidence of cancer cells in tissue removed during surgery vs. 2.2% of patients who received chemotherapy alone Opdivo- based therapies have now demonstrated positive results in Phase 3 trials in earlier stages of four different types of cancer: non-small cell lung cancer, esophageal/gastroesophageal junction cancer, bladder cancer and melanoma

United statesSouth koreaAbderrahim oukessouNina goworekBristol myers squibbInstitut curieNicolas girardCompany opdivoBristol myers squibb companyExchange commissionAmerican association for cancer researchAmerican association for cancer research annual meetingOno pharmaceutical coEuropean unionClinical trials plenary sessionAmerican association

CORRECTING and REPLACING Bristol Myers Squibb Announces Opdivo plus Chemotherapy and Opdivo plus Yervoy Demonstrate Superior Survival Benefit Compared to Chemotherapy in Unresectable Advanced or Metastatic Esophageal

CORRECTING and REPLACING Bristol Myers Squibb Announces Opdivo plus Chemotherapy and Opdivo plus Yervoy Demonstrate Superior Survival Benefit Compared to Chemotherapy in Unresectable Advanced or Metastatic Esophageal
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United statesSouth koreaIanm waxmanNina goworekBristol myers squibbCompany opdivoBristol myers squibb companyExchange commissionOno pharmaceutical coEuropean unionMyers squibb announcesDemonstrate superior survival benefit comparedUnresectable advancedMetastatic esophageal squamous cell carcinomaMyers squibbBristol myers