BMY Gets EC Nod for Opdivo Plus Yervoy in First-Line Colorectal Cancer

Core Insights - The European Commission has approved the combination of Opdivo and Yervoy for the first-line treatment of adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC) [1][20][14] - This approval is based on data from the phase III CheckMate -8HW study, which demonstrated a significant improvement in progression-free survival (PFS) and reduced the risk of disease progression or death by 79% compared to chemotherapy [12][7] - Opdivo, a key growth driver for Bristol Myers Squibb (BMY), generated global sales of $6.8 billion in the first nine months of the year, and the expansion of its label is expected to further boost sales [16][20] Approval and Study Data - The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended the approval of Opdivo plus Yervoy in November [6] - The latest approval makes Opdivo plus Yervoy the first dual checkpoint inhibitor therapy approved for first-line treatment of MSI-H/dMMR mCRC in the EU [14] - The safety profile of the combination therapy was consistent with previously reported data, showing no new safety signals [22] Other Developments - Bristol Myers also announced positive top-line data from two phase III studies evaluating Sotyktu (deucravacitinib) for treating adults with active psoriatic arthritis (PsA), with significant improvements in disease activity observed [3][17] - Sotyktu is already approved in several countries for treating moderate-to-severe plaque psoriasis [24]