By Colin Kellaher
Bristol Myers Squibb has won Food and Drug Administration priority review for its application seeking expanded approval of its blockbuster cancer drug Opdivo, in combination with chemotherapy, in certain patients with classical Hodgkin lymphoma, or cHL.
Bristol Myers on Thursday said the application covers Opdivo in combination with doxorubicin, vinblastine and dacarbazine for people 12 and older who have previously untreated stage III or IV cHL.
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.
The Princeton, N.J., drugmaker said the agency has set a target action date of April 8, 2026, for its application.
CHL accounts for 95% of cases of Hodgkin lymphoma, a cancer that starts in white blood cells called lymphocytes, which are part of the body's immune system, and is the most common cancer diagnosed in adolescents.
Opdivo, which harnesses the body's own immune system to fight cancer, generated more than $9.3 billion in revenue last year.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
12-11-25 0759ET
