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FDA Accepts BLA for Nivolumab Subcutaneous from Bristol Myers Squibb By Investing.com

PRINCETON, NJ – Bristol Myers Squibb (NYSE: NYSE: ) 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 in 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 for a decision by February 28, 2025.

The application is supported by data from the Phase 3 CheckMate -67T study, which demonstrated non-inferior pharmacokinetics and consistent safety of the subcutaneous formulation compared to the intravenous (IV) formulation in patients with advanced or metastatic renal clear cell carcinoma (ccRCC) who have received prior systemic therapy. The study also confirmed non-inferiority 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 subcutaneous PD-1 inhibitor, providing a faster 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 coordinator at Bristol Myers Squibb, highlighted the potential impact of subcutaneous nivolumab on patient care, noting its continued convenience and efficacy and safety profile compared to the IV formulation.

This news comes as part of Bristol Myers Squibbs’ broader commitment to cancer research and patient care, with the goal of providing 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 a key component of its immuno-oncology portfolio.

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The information in this article is based on a press release 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. Bristol Myers Squibb currently has a market cap of $89.17 billion, according to InvestingPro data. Despite a difficult period, with a reported revenue decline of 0.68% in the trailing twelve months to 2024Q1, the company managed a quarterly revenue growth of 4.66% in 2024Q1, signaling potential recovery and growth.

One of InvestingPro’s standout tips for BMY is that management has been actively engaging in share buybacks, which could indicate their confidence in the company’s future prospects. Additionally, Bristol Myers Squibb has maintained its dividend payouts for 54 consecutive years with a healthy dividend yield of 5.46%, demonstrating its commitment to returning value to shareholders.

For those interested in a deeper dive into Bristol Myers Squibb’s financial performance and future outlook, InvestingPro provides additional information. There are currently 12 more InvestingPro tips available that can provide a more comprehensive understanding of the stock’s potential. These tips include observations on stock valuation, the importance of dividends and the state of the industry, among others. To access these tips and more detailed metrics, visit https://www.investing.com/pro/BMY and don’t forget to use the coupon code PRONEWS24 to receive an additional 10% off an annual or bi-annual Pro and Pro+ membership.

This article was generated with AI support and reviewed by an editor. For more information, see T&C.

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