It's a drug we first told you about in January.
Zelboraf (vemurafenib) is a pill that blocks the B-RAF mutation, which drives melanoma in half of all patients. By blocking the mutation, Zelboraf slows tumors growth.
In tests, it stopped the cancer 3 times better than conventional chemotherapy. About 77 per cent of the people given Zelboraf during the trials are still alive, compared to 64 per cent with the older drug. However, melanoma adapts quickly, and patients taking Zelboraf saw their tumors begin to grow again after an average of 6 months.
The drug, made by Roche, is the first treatment for melanoma that targets a specific gene found in skin-cancer tumors. The FDA said Wednesday it also approved a test to screen patients for the mutation.
Side effects with the drug included skin rashes, joint pain, fatigue, diarrhea and hair loss. About 26 percent of patients developed a less serious form of skin cancer.
Melanoma is the fastest-growing form of cancer in terms of new diagnoses. Researchers attribute the acceleration to longer life expectancies among the elderly and increased indoor tanning by the young.
However, it has long been considered a very tough cancer to treat. Radiation and conventional chemotherapy only offer limited success.
About 68,000 people in the U.S. were diagnosed last year and 8,700 died, according to the American Cancer Society.
Zelboraf, which will be available in 2 weeks, is the second melanoma drug approved this year. In March, the FDA approved Yervoy, a Bristol-Myers Squibb
A six-month course of Zelboraf will cost about $56,400.