PRINCETON, N.J. - Bristol Myers Squibb (NYSE: NYSE:BMY) has announced the FDA's acceptance of their Biologics License Application (BLA) for a new subcutaneous formulation of Opdivo® (nivolumab), in combination with Halozyme™s proprietary recombinant human hyaluronidase (rHuPH20). This subcutaneous version is designed for use across all previously approved adult solid tumor indications of Opdivo as monotherapy or in various combinations. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for a decision by February 28, 2025.
The application is supported by data from the Phase 3 CheckMate -67T study, which demonstrated noninferior pharmacokinetics and consistent safety of the subcutaneous formulation compared to the intravenous (IV) form in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy. The study also confirmed noninferiority in terms of objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR).
If approved, subcutaneous nivolumab could become the first and only subcutaneously administered PD-1 inhibitor, offering a quicker and potentially more convenient treatment option for patients. The subcutaneous injection can be administered in three-to-five minutes, a significant reduction from the 30-to-60-minute infusion required for the IV form.
Gina Fusaro, Ph.D., vice president, global program lead at Bristol Myers Squibb, emphasized the potential impact of subcutaneous nivolumab on patient care, highlighting the convenience and maintained efficacy and safety profile compared to the IV formulation.
This news comes as part of Bristol Myers Squibb's broader commitment to cancer research and patient care, aiming to provide innovative treatments that improve patient outcomes. The company has a history of developing therapies that harness the body's immune system to fight cancer, with Opdivo being a key component of its Immuno-Oncology portfolio.
The information in this article is based on a press release statement from Bristol Myers Squibb.
InvestingPro Insights
As Bristol Myers Squibb (NYSE: BMY) makes strides in cancer treatment with its new subcutaneous formulation of Opdivo®, the company's financial health remains an important consideration for investors. According to InvestingPro data, Bristol Myers Squibb currently has a market capitalization of $89.17 billion. Despite a challenging period, with a reported revenue decline of 0.68% over the last twelve months as of Q1 2024, the company has managed a quarterly revenue growth of 4.66% in Q1 2024, signaling potential recovery and growth.
One of the standout InvestingPro Tips for BMY is that management has been actively engaged in share buybacks, which could be indicative of their confidence in the company's future prospects. Furthermore, Bristol Myers Squibb has maintained its dividend payments for 54 consecutive years, with a healthy dividend yield of 5.46%, showcasing a commitment to returning value to shareholders.
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