The U.S. Food and Drug Administration expanded the use of Bristol-Myers Squibb Co's skin cancer drug, Yervoy, as an additional therapy for patients with late-stage melanoma.
This approval extends Yervoy's use to patients with stage III melanoma, who have a high risk of recurrence after surgery, the agency said on Wednesday.
Due to the potential for fatal adverse reactions and unusual severe side effects with Yervoy, the drug's label carries a boxed warning - reserved for the most serious of risks.
Treatment for stage III patients has historically been challenging, with fewer options available. A diagnosis means that melanoma cells have been found in lymph nodes, and that the patient will require surgery.
Yervoy, administered intravenously, was originally approved in 2011 to treat late-stage melanoma that cannot be removed by surgery.
Melanoma is the most aggressive type of skin cancer, and will lead to an estimated 73,870 new cases and 9,940 deaths this year, the National Cancer Institute estimates.
Yervoy blocks a molecule known as CTLA-4, which may play a role in slowing down or turning off the immune system, and affects its ability to fight off cancerous cells.
The drug, known chemically as ipilimumab, raked in global sales of $240 million in the quarter ended Sept. 30, 2015.
Bristol-Myers' stock was little changed on the New York Stock Exchange after the bell on Wednesday.