Roche melanoma drug wins early FDA nod

The FDA came through with an early approval for Roche's new melanoma drug Zelboraf and the diagnostic test that targets it. The drug works on patients with a BRAF mutation, which amounts to about half of metastatic melanoma cases. Priced at $56,400 for 6 months of treatment, the Wall Street Journal reports, Zelboraf will run less than half the sticker price of Bristol-Myers Squibb's brand new melanoma treatment Yervoy.

Zelboraf and Yervoy have both fueled hopes among patients and doctors impressed by the trial data supporting their approvals. In one trial, 84% of Zelboraf patients were alive after 6 months, compared with 64% treated with chemotherapy alone. Tumor size was reduced in 48% of patients using Zelboraf, compared with 5% in the chemo-only group, as Bloomberg notes.

"This has been an important year for patients with late-stage melanoma," the FDA's oncology drugs chief Richard Pazdur said in a statement. "Zelboraf is the second new cancer drug approved that demonstrates an improvement in overall survival." Developed with Daiichi Sankyo, Zelboraf will be co-marketed by the two companies in U.S., with Roche owning full rights elsewhere.

Analysts peg peak sales of Zelboraf at around $732 million to $891 million. Expectations for Yervoy have tended to be higher, at $1.5 billion in sales by 2015. Those sales expectations could change, however, if a study finds benefits from using the two in tandem. Yervoy stimulates the immune system to fight off the cancer, an entirely different mechanism from Zelboraf's BRAF-blocking abilities. So it's possible that patients with the BRAF mutation might see even better results with dual treatment.

- check out the release from Roche
- find the FDA statement
- read the Reuters news
- get more from the WSJ
- see the Bloomberg story