The US Food and Drug Administration approved Roche's Zelboraf yesterday for the treatment of patients with advanced melanoma that is beyond the reach of surgery.
Zelboraf (vemurafenib) was approved two months ahead of schedule by the FDA and is the second melanoma drug to be approved in 2011 after Bristol-Myers Squibb's Yervoy (ipilimumab), which debuted in March.
Both Zelboraf and Yervoy have been hailed as a major advance in melanoma care, as they are the first new agents in over a decade to show any improvement in survival for patients with the disease. Roche and BMS are also working together to see if their two drugs can provide additional benefits when used in combination.
Zelboraf's approval was supported by a single international trial of 675 previously-untreated patients with late-stage melanoma. Patients were assigned to receive either Zelboraf or dacarbazine and the median survival of those on Zelboraf has still not been reached, with 77% of patients still alive. For comparison, the median survival for patients on dacarbazine was 8 months (64% still living).
The drug is a personalised medicine, and is designed for use only in melanoma patients whose tumours express a gene mutation called BRAF V600E. The approval package for Zelboraf also includes a diagnostic to screen melanoma patients for the gene mutation, which occurs in around half of all cases of the cancer. Last year, there were around 68,000 cases of melanoma diagnosed in the USA, with 8,700 people dying from the disease.
"The FDA approval of Zelboraf marks a major step forward in personalising the treatment of metastatic melanoma, a devastating disease that until this year had limited approved treatment options," said Hal Barron, Roche's chief medical officer.
"We will continue to study this medicine with a goal of further improving outcomes for people with melanoma and other cancers that are driven by BRAF mutations."
Roche has high hopes for Zelboraf, particularly as Yervoy has already made rapid progress since its launch. BMS said last month that the drug had garnered $95 million in its first quarter on the US market, and analysts have suggested that it could bring in $1.5 billion in 2015.
Estimates are that the cost of treatment with Zelboraf will be in the region of $50,000-$60,000 over a six-month period, and on that basis the drug could achieve around $900 million in 2015 sales, according to analysts.
Roche said Zelboraf would be launched within two weeks in the USA, and is also pending approval in the EU, Switzerland, Australia, New Zealand, Brazil, India, Mexico and Canada.