Bristol-Myers Gets FDA Acceptance of Review for Subcutaneous Opdivo Formulation

Dow Jones05-06

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 07:35 ET (11:35 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

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cancer ...</p>\n\n<a href=\"https://dowjonesnews.com/newdjn/logon.aspx?AL=N\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU0114720955.EUR","symbol_name":"SUSTAINABLE GLOBAL HEALTH CARE \"A\" INC","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2433321421","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2433321421","pubTimestamp":1714995300,"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"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 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