FDA Advances Decision on BMS's Subcutaneous Opdivo

Bristol Myers Squibb (BMS) announced on Tuesday that the FDA is anticipated to make a decision on its application for a subcutaneous version of Opdivo (nivolumab) by December 29, instead of the previously projected date at the end of February. The company did not provide reasons for the accelerated timeline.

The application is supported by findings from the Phase III CheckMate -67T study. In this trial, the subcutaneous form of the PD-1 inhibitor proved non-inferiority compared to its intravenous counterpart in a group of 495 patients who had advanced or metastatic clear cell renal cell carcinoma and had undergone prior systemic therapy. Should approval be granted, subcutaneous Opdivo would become the first PD-1 inhibitor administered subcutaneously to be authorized in the United States.

In the landscape of PD-1 inhibitors, BMS's competitor, Merck & Co., is also working on a subcutaneous version of its drug, Keytruda (pembrolizumab). Merck is expected to release Phase III data by the end of the year. This comes after Merck reprioritized its efforts following initial challenges with the subcutaneous formulation of Keytruda. Meanwhile, the subcutaneous version of Roche’s Tecentriq (atezolizumab) has encountered review problems in the U.S.

The potential approval of subcutaneous Opdivo marks a significant development in cancer treatment, offering an alternative to intravenous administration. This could enhance patient convenience and comfort, especially for those who require long-term treatment. Additionally, this formulation could potentially reduce the burden on healthcare facilities by shortening administration times and decreasing the need for infusion resources.

Overall, the expedited review by the FDA indicates a positive outlook for BMS's subcutaneous Opdivo, potentially setting a precedent for future developments in subcutaneous cancer therapies.