Roche melanoma drug wins early FDA nod

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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

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