▎WuXiEdited by Kant Content Team

Bristol-Myers Squibb today announced that the U.S. FDA has accepted the Biologics License Application (BLA) for its Opdivo (nivolumab) subcutaneous injection formulation, intended for all previously approved Opdivo adult solid tumor indications, including monotherapy, maintenance monotherapy following Opdivo and Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.The PDUFA date for this application is February 28, 2025.

The submission of this application is primarily based on data from the Phase 3 CheckMate-67T study. CheckMate-67T is a randomized, open-label Phase 3 clinical trial evaluating the efficacy of a subcutaneous formulation of Opdivo, formulated with Halozyme's proprietary recombinant human hyaluronidase rHuPH20, compared to intravenous Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have previously received systemic therapy.PreviouslyThe press release stated that the Opdivo subcutaneous formulation can be administered in a single injection within five minutes, potentially transforming the treatment experience for patients and doctors.

The analysis shows,The trial met its primary endpoint, demonstrating non-inferiority for subcutaneous Opdivo compared to intravenous Opdivo in terms of average serum concentration over 28 days (Cavgd28) and steady-state serum trough concentration (Cminss).Moreover, as assessed by the Blinded Independent Central Review (BICR), the subcutaneous formulation demonstrated non-inferiority in Objective Response Rate (ORR) compared to intravenous Opdivo, which is a key secondary endpoint.

In terms of safety, OpdIVO Subcutaneous FormulationSafety is consistent with intravenous formulations.

Opdivo is a PD-1 immune checkpoint inhibitor designed to harness the body's own immune system to help restore anti-tumor immune responses.Opdivo has become an important treatment option across multiple types of cancer. To date, the Opdivo clinical development program has treated more than 35,000 patients.

References:

[1] U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Application for Subcutaneous Nivolumab (nivolumab and hyaluronidase). Retrieved May 6, 2024 from https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Application-for-Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase/default.aspx

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