FDA Approves Broader Label for GSK’s Jemperli in First-Line Endometrial Cancer

FDA, GSK, Jemperli, dostarlimab-gxly, endometrial cancer, chemotherapy, carboplatin, paclitaxel, mismatch repair proficient, microsatellite stable, overall survival, progression-free survival

BMS Details Confirmatory Trial Win for KRAS Inhibitor Krazati

Bristol Myers Squibb, Krazati, KRAS inhibitor, confirmatory trial, non-small cell lung cancer (NSCLC), progression-free survival (PFS), chemotherapy, accelerated approval, FDA

AstraZeneca’s Imfinzi Demonstrates Survival Benefit in Limited-Stage Small Cell Lung Cancer Study

AstraZeneca, Imfinzi (durvalumab), Small Cell Lung Cancer (SCLC), Limited-stage SCLC, ADRIATIC Phase III study, Overall Survival (OS), Progression-Free Survival (PFS), Immunotherapy

Expansion of Pluvicto Use Sought by Novartis Following Positive Prostate Cancer Study Update

Novartis, Pluvicto, Broader use, Prostate cancer, PSMAfore trial, Radiographic progression-free survival (rPFS), Metastatic castration-resistant prostate cancer (mCRPC)

Gritstone Cancer Vaccine Trial Misses Primary Endpoint, Stock Plummets

Gritstone, Personalized Neoantigen Cancer Vaccine, Colorectal Cancer, Phase 2 Study Failure, Circulating Tumor DNA (ctDNA), Progression-Free Survival (PFS), Stock Market Reaction

Bristol Myers Squibb’s KRAZATI Confirmed Effective in Pivotal Phase 3 KRYSTAL-12 Trial Following Accelerated Approval

Bristol Myers Squibb, KRAZATI (adagrasib), Pivotal Phase 3 trial, KRYSTAL-12 study, Primary endpoint met, Progression-free survival (PFS), Overall response rate (ORR), Confirmatory trial, Non-small cell lung cancer (NSCLC), Locally advanced or metastatic, KRASG12C mutation, Accelerated approval, Continued approval contingent on clinical benefit verification, FDA assigned PDUFA goal date of June 21/ 2024

J&J Scores First-Line Approval for Rybrevant Combination in Lung Cancer with EGFR Exon 20 Mutations

Johnson & Johnson, Rybrevant (amivantamab-vmjw), FDA Approval, First-Line Treatment, Non-Small Cell Lung Cancer (NSCLC), EGFR Exon 20 Insertion Mutations, Carboplatin-Pemetrexed Chemotherapy, Phase 3 PAPILLON Study, Reduced Disease Progression or Mortality Risk, Improved Objective Response Rate (ORR) and Progression-Free Survival (PFS)