Roche Holding AG got approval from US FDA to market its skin cancer drug Zelboraf for certain patients with Erdheim-Chester Disease, a rare type of blood cancer.
The Food and Drug Administration approved Zelboraf to treat patients with Erdheim-Chester Disease whose cancer cells have a genetic mutation known as BRAF V600. It is the first FDA-approved treatment for the disease.
Zelboraf is already approved to treat melanoma, the most serious type of skin cancer, in patients whose cancer cells also contain a BRAF V600 mutation. Only 600 to 700 patients world-wide suffer from Erdheim-Chester Disease, and about 54 percent of those have the BRAF V600 mutation, the FDA said.