FDA Criticizes Bristol Myers Squibb for Misleading Efficacy Claims on Krazati Website

Bristol Myers Squibb, FDA, Krazati, misleading efficacy claims, non-small-cell lung cancer, NSCLC, KRAS G12C-mutated, cancer treatment

FDA Raises Concerns Over Potential Overtreatment with AstraZeneca’s Imfinzi for NSCLC

AstraZeneca, Imfinzi, NSCLC, FDA, Overtreatment, Adcomm, Perioperative Treatment, Immune Checkpoint Inhibitors, Neoadjuvant Chemotherapy, Adjuvant Monotherapy

Merck and Daiichi Sankyo’s ADC Pact Hits Regulatory Setback in FDA Rejection

Merck, Daiichi Sankyo, Antibody-Drug Conjugate (ADC), Patritumab Deruxtecan, FDA Rejection, Regulatory Setback, HER3 Protein, Non-Small Cell Lung Cancer (NSCLC)

RYBREVANT: A Breakthrough in Lung Cancer Treatment

RYBREVANT, lung cancer, EGFR mutations, subcutaneous administration, intravenous administration, infusion-related reactions, survival rate, non-small cell lung cancer (NSCLC)

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

Alecensa: FDA-Approved First ALK Inhibitor for Adjuvant Treatment in Early-Stage ALK-Positive NSCLC

Alecensa, ALK Inhibitor, Adjuvant Treatment, Early-Stage ALK-Positive NSCLC, FDA Approval, Genentech, Roche Group, ALINA Study, 76% Reduction in Disease Recurrence or Death, NCCN Guidelines

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