Saturday, March 2, 2024

BMS’s Opdivo Accepted for Supplemental Biologics Application in Lung Cancer by US and EU Authorities

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Bristol Myers Squibb’s neoadjuvant Opdivo combined with chemotherapy for resectable stage IIA to IIIB non-small cell lung cancer (NSCLC) treatment received FDA acceptance for its supplemental Biologics Application (sBLA), with a decision expected by October 8, 2024. Concurrently, the European Medicines Agency (EMA) validated the type II variation application, initiating the centralized review process.

The applications are based on findings from the Phase 3 CheckMate -77T trial, marking the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for resectable NSCLC treatment. The trial demonstrated significant improvement in event-free survival (EFS), the primary endpoint, compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo. Additionally, the regimen showed benefits in secondary endpoints including pathologic complete response (pCR) and major pathologic response (MPR), with a safety profile consistent with previous NSCLC studies.

Opdivo’s Efficacy Across Multiple Cancers and FDA Acceptance for Supplemental Biologics Application

Opdivo and Opdivo-based combinations have shown efficacy in neoadjuvant, adjuvant, or perioperative settings across various cancers, including lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer, and melanoma.

The CheckMate -77T trial is a Phase 3 randomized, double-blind, placebo-controlled, multicenter trial evaluating neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo versus neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo in 452 patients with resectable stage IIA to IIIB NSCLC. Secondary endpoints include overall survival (OS), pCR, and MPR.

Supplemental Biologics Application

BMS’s Commitment to Innovative Cancer Treatments and the Quest for Improved Outcomes

NSCLC is the leading cause of cancer deaths globally, and the majority of cases are non-metastatic. While many patients are cured by surgery, a significant portion experience recurrence and succumb to the disease despite resection, underscoring the need for treatment options to improve long-term outcomes.

Bristol Myers Squibb remains committed to transforming patients’ lives through innovative cancer research, aiming to deliver medicines that offer each patient a better, healthier life and make cure a possibility. Their comprehensive approach to cancer treatment encompasses a broad range of cancers and focuses on personalized medicine and innovative digital platforms to improve patient outcomes throughout their journey.


Resource: Bristol Myers Squibb, February 07, 2024

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