Key Takeaways Opdivo led BMY's Q1 sales at $2.26B, driven by strong demand across multiple cancer indications. EC and FDA approvals expand Opdivo's use in NSCLC, HCC, and colorectal cancer treatment regimens. BMY trades at 7.37x forward earnings amid generic threats and lagging shares, down 13.9% year to date.Bristol Myers’ (BMY) growth portfolio primarily comprises Opdivo, Orencia, Yervoy, Reblozyl, Opdualag, Abecma, Zeposia, Breyanzi, Camzyos, Sotyku, Krazati and others.Among these, immuno-oncology drug ...

Core Insights - The European Commission has approved the subcutaneous formulation of Opdivo (nivolumab) for multiple solid tumor indications, making it the first PD-1 inhibitor approved for subcutaneous use in the EU [1][3]. Approval Details - The approval applies to all 27 EU member states, as well as Iceland, Norway, and Liechtenstein [1]. - Nivolumab for subcutaneous use is co-formulated with recombinant human hyaluronidase and is indicated for various adult solid tumors, either as monotherapy or in combination with other therapies [2][4]. Clinical Study Findings - The approval was supported by data from the CheckMate -67T clinical study, which demonstrated that the subcutaneous formulation has a pharmacokinetics and safety profile comparable to the intravenous version [4]. - The study showed that the subcutaneous formulation met primary pharmacokinetic noninferiority endpoints, with a geometric mean ratio for Cavgd28 of 2.10 and for Cminss of 1.77 [7]. - The objective response rate was 24% in the subcutaneous group compared to 18% in the intravenous group, indicating comparable efficacy [7]. Market Performance - Bristol Myers' shares have declined by 17% year to date, while the industry has seen a decline of 5.4% [3].