Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics Application (sBLA) for the use of neoadjuvant Opdivo (nivolumab) with chemotherapy, followed by surgery and adjuvant Opdivo as a perioperative treatment for patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). A target action date is set for October 8, 2024. Additionally, the European Medicines Agency (EMA) validated the type II variation application, which initiates the review process in Europe.

This acceptance is based on the Phase 3 CheckMate -77T trial results, the company’s second positive Phase 3 randomized immunotherapy-based combination trial for NSCLC. The trial demonstrated a statistically significant improvement in event-free survival (EFS) along with benefits in key secondary endpoints, including pathologic complete response (pCR) and major pathologic response (MPR). The safety profile was consistent with previously reported studies in NSCLC, and no new safety concerns were identified.

The EFS, pCR, and MPR results from the CheckMate -77T trial were presented at the European Society of Medical Oncology (ESMO) Congress in 2023. The ongoing study will also evaluate overall survival as another secondary endpoint.

Opdivo, including Opdivo-based combinations, has demonstrated efficacy in various settings across multiple cancers, such as lung, bladder, and esophageal/gastroesophageal junction cancers. The acceptance of these regulatory applications highlights Bristol Myers Squibb’s commitment to addressing unmet needs in NSCLC treatment, particularly in earlier stages, and reflects their progress in offering patients potential new treatment options.

Source link: http://www.businesswire.com/news/home/20240206288537/en/Bristol-Myers-Squibb-Announces-Acceptance-of-U.S.-and-EU-Regulatory-Filings-for-Neoadjuvant-Opdivo-nivolumab-and-Chemotherapy-Followed-by-Surgery-and-Adjuvant-Opdivo-in-Resectable-Non-Small-Cell-Lung-Cancer

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Ferry Darma
Ferry Darma is Director of Media Relations at The Clinical Trial Vanguard. Ferry, a computer data scientist, focuses on the latest clinical trial industry news and trends.