FDA to Review Bristol-Myers's Opdivo for Hodgkin Lymphoma

The U.S. Food and Drug Administration has accepted Bristol-Myers Squibb Co.'s supplemental biologics license application to expand the use of its cancer drug Opdivo to patients who are facing difficult-to-treat variations of Hodgkin lymphoma, the pharmaceutical company said Thursday.

Bristol-Myers wants to use Opdivo to treat patients with classical Hodgkin lymphoma—a type of cancer that most often starts in the lymph nodes—who have already tried other therapies.

The FDA granted the application a priority review. Opdivo, launched in late 2014 to treat skin cancer, was Bristol's fastest-growing drug in 2015 with sales of $942 million. The drug is part of an emerging field of cancer immunotherapies, which work by unleashing the body's immune system to attack tumors.

"There is a significant burden on classical Hodgkin lymphoma patients who do not respond to initial treatment, and they need new treatment options that address the disease in a different way," said Jean Viallet, Bristol-Myers' oncology global clinical research lead.

Some cancer cells are able to exploit the normal operations of cells to hide from the immune system and shield the tumor from attack. Opdivo aims to prevent this interference with the body's anti-tumor response.

In addition to skin cancer, Opvido also is used to treat non-small cell lung cancer and kidney cancer.

Write to Austen Hufford at [e-mail]

(END) Dow Jones Newswires

April 14, 2016 09:05 ET (13:05 GMT)

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