Pharma Strategy Blog

A Reuters press release on vemurafenib (Zelboraf) caught my eye this morning, suggesting that it might be approved in BRAFV600E metastatic melanoma by the FDA might be “imminent” according to an unnamed source and much earlier than the expected PDUFA date in November October 28th (now confirmed by Roche/Genentech).

If so, that’s very good news.

However, what really caught my eye was a quote from a spokesperson at Roche Diagnostics, suggesting that the BRAFV600E test would could around $150.  That’s lower than I was expecting, although no doubt it will be considerably offset by the cost of vemurafenib itself.

It was also good to hear recently that Roche and BMS, the manufacturers of ipilimumab (Yervoy), have now met to discuss and finalise the much anticipated combination trial of Zelboraf and Yervoy.  It will be interesting to see if the combination will extend survival even further in patients with the V600E mutation.  There’s a long way to go before the results bear fruit, as an early dose finding and tolerability study will be the first step in the process.

Of course, pricing and reimbursement will be key, given that Yervoy was launched recently with a $120K price tag for four infusions.  On the 2Q earnings call the other week, BMS announced that the launch was going well and uptake was strong.  It is given as a 3mg infusion every three weeks for 4 cycles, over a 3 month period.  It will be interesting to see what the Zelboraf monthly price will be, assuming it successfully garners approval.   Should the combination work out in the future, the cost of treating metastatic melanoma will likely become even more expensive despite only small incremental survival benefits.