You are here
FDA Expands Use of Bristol-Myers' Cancer Drug Yervoy
The FDA has expanded the use of Bristol-Myers Squibb's skin cancer drug ipilimumab (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.
Reuters notes that due to the potential for fatal adverse reactions and unusual severe side effects, Yervoy's label carries a boxed warning.
Treatment for stage III melanoma 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, the most aggressive type of skin cancer, will lead to an estimated 73,870 new cases and 9,940 deaths this year, the National Cancer Institute projects.
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 raked in global sales of $240 million in the quarter ending September 30, 2015.
Source: Reuters, October 29, 2015.