- FDA approves Mekinist in combination with Tafinlar to treat patients with advanced melanoma
- FDA approves combination of two GSK drugs for skin cancer
- FDA approves Bristol-Myers Squibb's, AstraZeneca's Farxiga
- Senate passes Drug Quality and Security Act
- Diplomat becomes distributor of recently approved cancer drug
SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for late-stage skin cancer, the agency said Friday.
The FDA approved Bristol-Myers Squibb’s Yervoy (ipilimumab) for patients with melanoma that has spread to other parts of the body, also known as metastasis. More than 68,000 new cases of melanoma were diagnosed in the United States in 2010, and about 8,700 died from it, according to the National Cancer Institute, part of the National Institutes of Health.
“Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient’s life,” FDA Office of Oncology Drug Products director Richard Pazdur said. “Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live longer by taking this treatment.”
The news comes after the company reported that the drug boosted survival rates among patients in a late-stage clinical trial.