Bristol Myers Squibb says the FDA is reviewing subcutaneous Opdivo (nivolumab) and plans a decision by the end of February, setting up a potential lifecycle extension for the PD-1 inhibitor ahead of its 2028 patent expiry. The filing is backed by the Phase III CheckMate-67T study, where subcutaneous Opdivo was noninferior to IV dosing in 495 patients with advanced or metastatic clear cell renal cell carcinoma previously treated with systemic therapy, with a safety profile consistent with the IV formulation.

Why It Matters To Oncology

• A subcutaneous PD-1 option could materially reduce treatment time and may expand administration beyond traditional infusion settings.

• For clinicians, that could improve patient convenience and infusion-center capacity while preserving efficacy and safety comparable to IV nivolumab.

• The move also sharpens competition with Merck’s Keytruda, whose subcutaneous program appears to trail Opdivo’s current regulatory timeline.

The Financials

• BMS disclosed the regulatory update after a first-quarter sales slump that included an Opdivo revenue miss.

• With Opdivo’s main patent set to expire in 2028, CEO Chris Boerner said in January that a subcutaneous formulation could help retain upwards of 65% of U.S. sales.

• That matters in a market where Keytruda generated $25 billion in 2023 and now posts sales nearly triple those of Opdivo.

What They're Saying

• BMS is positioning the filing as a meaningful regulatory win for a franchise that has seen comparatively flat revenue since 2018.

• Oncologists surveyed by FirstWord earlier this year said subcutaneous PD-(L)1 inhibitors could significantly benefit patients because of shorter treatment times and the possibility of use outside healthcare facilities.

• CheckMate-67T also supports a familiar clinical message: noninferior efficacy with no new safety signal versus the established IV formulation.

What's Next

• The key catalyst is the FDA decision expected by the end of next February.

• If approved, BMS will likely push rapid uptake in settings where chair time, staffing and patient throughput are major constraints.

• Clinicians and drug developers will also watch whether subcutaneous checkpoint inhibitors can meaningfully defend share as biosimilar and competitive pressures build.