This morning the FDA approved vemurafenib (Zelboraf), along with it’s companion diagnostic, for the treatment of metastatic melanoma in patients with the BRAF V600E mutation.

This is great news!

ZELBORAF logo 300x116 Zelboraf approved by the FDA in BRAF V600E metastatic melanoma

The approval has been granted ahead of time, as correctly mentioned in the Reuters article recently. This means we now have two new therapies for the treatment of metastatic melanoma after ipilimumab (Yervoy) was approved in March.

These two new drugs have been rapidly approved within the space of a couple of months following the presentation of the data at the ASCO plenary session in June.

Very little has changed in this landscape since the original approval of dacarbazine (DTIC) many years ago, but the good news is that oncologists now have two new agents to consider for treatment in 2011, which is very much a grand cru year for melanoma.

Zelboraf (link to PDF of the PI) differs from Yervoy in that it is not an immunotherapy to CTLA4, but a small molecule tyrosine kinase inhibitor that targets BRAF and more specifically, one of the mutations driving the disease, V600E.  This mutation is seen in approximately half of patients with metastatic melanoma.  The companion diagnostic (from Roche’s diagnostic division) will enable oncologists to test patients upfront and determine who should receive the therapy since the clinical results have only been demonstrated in those with the mutation.

The hot question is what is the price?

Well, according to Roche/Genentech, the monthly price of Zelboraf will be $9,400 and assumes an average of ~6 months of treatment based on the progression-free survival (PFS) data reported in the phase III BRIM3 (5.3 months) and phase II BRIM2 (6.1 months) studies. The overall survival had not been reached at that time. This means the course of treatment with Zelboraf will be approximately $56,400, but will obviously depend on how long it is taken for.  The comparative cost of treatment for ipilimumab for four infusions is $30K per infusion or $120K per full course.

In addition, the cost of the diagnostic test will likely vary depending upon the laboratory, but it is expected will be determined by the test volume and contract framework established with the laboratory.  The Average Selling Price (ASP) for the cobas BRAF test will be ~$120-150 per test in the US, which is very reasonable.

All in all, news like this will bring a smile to many today – it’s always good to hear of new drugs that make a difference to the lives of cancer patients.