Bristol-Myers Gets FDA Acceptance of Review for Subcutaneous Opdivo Formulation
By Colin Kellaher
Bristol Myers Squibb on Monday said the Food and Drug Administration has accepted its application seeking approval of an subcutaneous formulation of its blockbuster cancer drug Opdivo.
The Princeton, N.J., biopharmaceutical company said the application covers Opdivo co-formulated with Halozyme's Enhanze drug-delivery technology across all previously approved adult, solid-tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib.
Opdivo, which harnesses the body's own immune system to fight cancer and generated more than $9 billion in revenue last year, is currently administered intravenously.
Bristol Myers said the FDA has set a target action date for the application of Feb. 28, 2025, adding that an FDA green light would make Opdivo the first and only subcutaneously administered PD-1 inhibitor.
Bristol-Myers and San Diego biopharmaceutical company Halozyme in 2017 inked a collaboration and license agreement to develop subcutaneously administered Bristol-Myers medicines using Halozyme's Enhanze technology, a recombinant human hyaluronidase solution used to facilitate the subcutaneous delivery of injected drugs and fluids.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 06, 2024 07:50 ET (11:50 GMT)
Copyright (c) 2024 Dow Jones & Company, Inc.-
How Anti-Obesity Drugs Are Innovating the Healthcare Market
-
What’s Happening In the Markets This Week
-
Why Immigration Has Boosted Job Gains and the Economy
-
What to Invest in During High Inflation
-
Never Mind Market Efficiency: Are the Markets Sensible?
-
Starbucks Stock Could Use a Pick-Me-Up After Big Selloff; Is it a Buy?
-
5 Cheap Stocks to Buy From an Attractive Part of the Market
-
Markets Brief: All Eyes On Inflation
-
After Earnings, Is Lyft Stock a Buy, a Sell, or Fairly Valued?
-
8 Stock Picks in the Apparel Industry
-
Baidu Earnings: Advertising Weakness Offset by Continued Growth In Cloud Business
-
Going Into Earnings, Is Target Stock a Buy, a Sell, or Fairly Valued?
-
Walmart Earnings: Low Prices and Strong Digital Presence Drive Market Share Gains
-
After Earnings and a Big Selloff, Is Shopify Stock a Buy, a Sell, or Fairly Valued?
-
Cisco Earnings: Positive Guidance and Splunk Inclusion Align With Our Long-Term Thesis
-
3 Warren Buffett Stocks to Buy After Berkshire Hathaway’s Just-Released 13F Filing