Roche skin cancer drug approval ‘imminent’
pharmafile | August 11, 2011 | News story | Sales and Marketing | Roche, melanoma, vemurafenib
Skin cancer treatment Zelboraf looks set to gain FDA approval months ahead of schedule.
Roche and Daiichi Sankyo’s drug is designed to treat the BRAF V600 mutation in metastatic melanoma, the deadliest form of skin cancer.
An FDA decision had been expected in October, but the ruling will be brought forward so patients can benefit from treatment sooner.
A source familiar with the situation told Reuters that Zelboraf (vemurafenib) could be approved within the next week.
An accompanying test developed by Roche’s diagnostics arm will be approved alongside the drug. The test is needed to identify the V600 mutation in the BRAF gene, which is only expressed in around half of all melanoma patients.
The drug’s impressive phase III results have consistently shown a gain in overall survival.
The late-stage BRIM3 study showed vemurafenib significantly improved overall survival in patients with previously untreated BRAF V600 mutation-positive metastatic melanoma, compared to chemotherapy alone.
The study showed the risk of death was reduced by an unprecedented 63% for those taking vemurafenib, compared to patients on the chemotherapy arm.
Roche said that median overall survival (OS) rates couldn’t yet be estimated because of the small number of patients in long-term follow-up. However, it has released median OS estimates from an earlier BRIM3 study in January, which saw patients receiving vemurafenib living 9.2 months compared to 7.8 months for those receiving chemotherapy.
After an additional two months of follow-up, median OS increased to 10.5 months for patients receiving vemurafenib, while the median OS estimate for patients receiving chemotherapy remained at 7.8 months. Further data will be released later this year after the long-term follow up study is completed.
However trials have shown that patients receiving the drug can develop resistance quite rapidly. Oncologists say the best way to fight the problem of resistance is to combine the drug with other treatments.
Roche has not released details of its planned price for its drug and will keep that close to their chest until launch, but it has said that the diagnostic kit will cost around $150.
It is expected to reach peak annual sales of around $700 million, much less than the $1.4 billion expected of its first-to-market rival Yervoy (ipilimumab), which was recently approved by both the FDA and the EMA.
Bristol-Myers Squibb’s drug works by stimulating an immune response against the melanoma, and can potentially work on all forms of the disease.
It has already achieved sales of $79 million in its first full quarter on the market, far ahead of analysts’ predictions – and despite its hefty $120,000 price tag.
But the two firms last month announced a partnership for the two drugs, in order to combat the disease on both fronts, potentially increasing uptake for both treatments.
Ben Adams
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