European approval for Roche’s Zelboraf
pharmafile | February 20, 2012 | News story | Sales and Marketing | Cancer, Roche, Yervoy, Zelboraf, melanoma
Roche’s skin cancer pill Zelboraf has been given European approval to treat advanced melanoma.
Zelboraf (vemurafenib) is now available in Europe for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
The cobas 4800 BRAF V600 Mutation Test, a diagnostic co-developed by Roche to identify patients eligible for treatment, is also commercially available in Europe.
The decision was widely expected after the CHMP advised for its approval in December – the drug was first approved in the US last year.
Hal Barron, head of global product development, said: “Today’s approval is important news for people with BRAF mutation-positive metastatic melanoma as Zelboraf significantly improves patient survival and exemplifies the benefits that Roche’s personalised approach to medicine can provide for patients, physicians and society.”
Zelboraf is being co-developed under a 2006 licence and collaboration agreement between Roche and Plexxikon, a member of the Daiichi Sankyo Group.
Analysts’ forecasts see the drug making around $750 million in peak annual sales.
The drug targets the BRAF protein, which is a key component of the RAS-RAF pathway involved in normal cell growth and survival.
Mutations that keep the BRAF protein in an active state may cause excessive signalling in the pathway, leading to uncontrolled cell growth and survival.
These mutations are thought to occur in around half of all melanomas, and 8% of solid tumours.
The approval is based on a pivotal Phase III trial that showed Zelboraf improved progression-free survival by about 4 months (5.3 months for vemurafenib compared to 1.6 months for chemotherapy agent dacarbazine).
It also increased overall survival by about 3 months (13.2 months for Zelboraf compared to 9.9 months for dacarbazine), in patients who tested positive for BRAF V600 mutations.
It will now compete with Bristol-Myers Squibb’s immunotherapy treatment Yervoy (ipilimumab), which is also licensed in Europe to treat advanced melanoma.
But Yervoy’s high cost of £80,000 per year, per patient, has seen it fall foul of the UK cost watchdog NICE, which has said in draft guidance that it will not recommend the drug for funding on the NHS.
NICE will start its appraisal on Zelboraf in the coming weeks, and is scheduled to make its final decision on the drug in October.
But once the drug is launched in England it will eligible for funding via the £200 million Cancer Drugs Fund, which pays for new cancer drugs that are going through the NICE appraisal system, or that have been rejected by the watchdog.
Ben Adams
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