Reuters reports that Roche's experimental melanoma drug vemurafenib appears headed for an early approval by the FDA, well ahead of its scheduled November 11 date. The agency is apparently encouraged by some dramatic evidence that the drug significantly cut the risk of death versus chemotherapy.
Vemurafenib, which will be named Zelboraf on the market, is likely to join a roster of new cancer drugs to gain FDA approval. Others include Bristol-Myers Squibb's melanoma drug Yervoy and J&J's prostate cancer therapy Zytiga, and Dendreon's Provenge also for prostate cancer. Peak sales of vemurafenib have been estimated at more than $700 million a year. See Fierce Biotech.
The Pharma Strategy blog notes that Roche and BMS, the manufacturers of ipilimumab (Yervoy), have now met to discuss and finalize 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 BRAFV600E mutation.
Yervoy was launched recently with a $120K price tag for four infusions. Sales are apparently were good in Q2. 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.
It will also be interesting to see how this expensive cocktail with relatively modest survival benefits will fare at this high cost - especially vis a vis Dendreon's Provenge. The latter offers about a 4 months survival benefit at a cost of $93,000 per patient that is incurred in about 1month of treatment. Dendreon has reported issues in getting physician's to prescribe the cost dense Provenge due to reimbursement concerns. Will a Yervoy and Zelboraf cocktail surmount this hurdle? If the cocktail does succeed, is that indicative of a better patient benefit or a better selling strategy to prescribers and third-party payers?
Posted by Bruce Lehr Aug 9th 2011.