FDA to Decide on BMS’s Subcutaneous Opdivo Early Next Year

Bristol Myers Squibb (BMS), after facing a first-quarter sales decline and a revenue shortfall for its cancer treatment Opdivo (nivolumab), has announced a significant regulatory development that could revitalize interest in the drug. The U.S. Food and Drug Administration (FDA) is currently reviewing an application for a subcutaneous formulation of Opdivo, with a decision expected by the end of February next year. This new injectable version has the potential to benefit both BMS and patients significantly.

Opdivo's main patent is set to expire in 2028, and the introduction of a subcutaneous formulation could help BMS maintain up to 65% of its U.S. sales, as stated by CEO Chris Boerner at the JP Morgan Healthcare conference in January. This shift could offer BMS a competitive edge, particularly as Opdivo has lagged behind its rival, Merck & Co.’s Keytruda (pembrolizumab), in revenue generation. Keytruda, which has outpaced Opdivo since 2018, reported sales of $25 billion in 2023, nearly three times that of Opdivo.

The proposed subcutaneous version of Opdivo is based on findings from the Phase III CheckMate -67T study. This study involved 495 patients with advanced or metastatic clear cell renal cell carcinoma who had previously undergone systemic therapy. Results showed that the subcutaneous formulation was noninferior to the intravenous (IV) version of the drug. Additionally, the injectable version's safety profile was consistent with that of the IV formulation, suggesting that it could be a viable alternative for patients.

A FirstWord poll conducted earlier this year among oncologists indicated that subcutaneous PD-(L)1 inhibitors could significantly benefit patients by reducing treatment times and allowing for administration outside of healthcare facilities. This is seen as a promising development, particularly for patients who may have difficulty accessing traditional healthcare settings for their treatments.

Moreover, the approval of a subcutaneous formulation could give Opdivo a much-needed boost against Keytruda. While Merck's Keytruda sales have soared, an injectable version of Keytruda is still in development. A first-generation attempt at creating a subcutaneous Keytruda was deprioritized, and the current leading candidate is expected to present Phase III data by the end of this year.

In summary, BMS's regulatory win with the FDA review of a subcutaneous formulation of Opdivo represents a strategic move to maintain its market presence as its primary patent nears expiration. If approved, the new formulation could offer significant benefits to patients, potentially reducing treatment times and enabling easier administration. This development could also position Opdivo more favorably against its main competitor, Keytruda, whose injectable version is still under development.