By Colin Kellaher
Bristol Myers Squibb won a priority review from the Food and Drug Administration for its application seeking expanded approval of a combination of its blockbuster cancer drug Opdivo and chemotherapy in certain patients with bladder cancer.
The New York biopharmaceutical company on Tuesday said the application covers Opdivo in combination with cisplatin-based chemotherapy as a first-line treatment for adults with bladder cancer that cannot be surgically removed or has spread to other parts of the body.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.
Bristol Myers said the regulator set a target action date of April 5 for the application, adding that a green light would make the Opdivo-based regimen the first immunotherapy-chemotherapy combination approved for the targeted patient population in the U.S.
Opdivo, which harnesses the body's own immune system to fight cancer, is approved in more than 65 countries across multiple cancers and generated revenue of more than $6.6 billion in the first nine months of 2023.
Write to Colin Kellaher at firstname.lastname@example.org
(END) Dow Jones Newswires