CHMP Issues Positive Opinion for Label Expansion of BMY's Opdivo

Core Viewpoint - Bristol Myers Squibb (BMY) has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the approval of Opdivo (nivolumab) for additional indications in treating non-small cell lung cancer (NSCLC) and for a subcutaneous formulation across multiple solid tumor indications [1][10]. Group 1: Opdivo Approval and Clinical Trials - The CHMP recommended Opdivo in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy after surgical resection for high-risk resectable NSCLC patients with PD-L1 expression ≥1% [2]. - The positive CHMP opinion was based on the CheckMate-77T trial, which showed significant improvement in event-free survival compared to neoadjuvant chemotherapy and placebo [3]. - The CheckMate-77T study also demonstrated improvements in secondary efficacy endpoints, including pathologic complete response and major pathologic response (MPR) [4]. Group 2: Market Performance and Growth - BMY's shares have increased by 21.4% over the past year, contrasting with a 7.1% decline in the industry [9]. - The approval of Opdivo Qvantig for subcutaneous use is expected to enhance the immuno-oncology franchise's impact into the next decade [12]. - BMY's growth portfolio, including drugs like Reblozyl, Breyanzi, Camzyos, and Opdualag, has stabilized revenue amid generic competition [13]. Group 3: Recent Acquisitions and New Approvals - BMY recently acquired 2seventy bio, Inc. for $286 million, with plans to close the acquisition in the second quarter of 2025 [15]. - The approval of Cobenfy for schizophrenia represents a new pharmacological approach, with initial sales of $10 million in 2024 expected to contribute significantly to BMY's revenue [14].