Earlier this week, Roche also got early approval for its cancer drug Zelboraf (vemurafenib) for the treatment of BRAF V600E melanoma -- a full two months ahead of its PDUFA date. The approval marked a key milestone in personalizing treatment of metastatic melanoma. This is good news for melanoma patients. In fact, it is the second major new drug approved against melanomas this year -- the other being BMS' Yervoy (ipilumumab).
Zelboraf is a small molecule tyrosine kinase inhibitor that targets BRAF -- specifically the V600E mutation. This mutation is seen in approximately half of patients with metastatic melanoma. The companion diagnostic (also from Roche) 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. That's cool. We can identify a clear population in which the drug will work.
As mentioned in the previous post on Adcetris, pricing is a hot topic of interest. Roche plans to sell the drug for $56,400 per treatment course. Yervoy (mentioned above) sells for approximately $120,000 per course. Wow these are expensive but do result in progression free survival in range of 5-6 months. All in all it is an advance in the treatment of melanoma patients. And it also represents a continuation of the increase in the number of approvals that we are seeing from the FDA. See the Pharma Strategy blog for more.
Posted by Bruce Lehr Aug 19th 2011.