EMA panel gives positive opinion for Roche’s Zelboraf
pharmafile | December 16, 2011 | News story | Sales and Marketing | EMA, Roche, Zelboraf
The EMA’s advisory committee is recommending the approval of Roche’s skin cancer drug Zelboraf.
The European regulator’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Zelboraf (vemurafenib).
Roche’s drug is a novel protein-kinase inhibitor that is seeking a European licence to treat patients suffering from metastatic or unresectable melanoma with BRAF V600 mutations, the deadliest form of skin cancer.
The drug has been shown to increase the risk of developing less serious skin cancers, but the CHMP considered the “magnitude of the risk was likely to be low”.
The final decision will come from the European Commission, which is expected in February next year.
Hal Barron, head of global product development at Roche, said: “The CHMP recommendation to approve Zelboraf represents an important milestone for people with metastatic melanoma who until recently had limited treatment options.
“We are working closely with health authorities worldwide to bring Zelboraf to people with this deadly disease as soon as possible.”
In one pivotal clinical trial, Zelboraf was shown to improve progression-free survival by about 4 months (5.3 months for vemurafenib compared to 1.6 months for chemotherapy agent dacarbazine).
Even more impressively, it also increased overall survival by about 3 months (13.2 months for vemurafenib compared to 9.9 months for dacarbazine), in patients who tested positive for BRAF V600 mutations.
The drug was first approved in the US earlier this year. If approved in Europe, Zelboraf will compete with Bristol-Myers Squibb’s new melanoma drug Yervoy, which works as an immunotherapy.
Yervoy’s high cost of £75,000 per year, per patient, has seen it fall foul of the UK cost watchdog NICE, which has said in draft guidance that it will not recommend the drug for funding on the NHS.
If approved, NICE is scheduled to make its final decision on Zelboraf in October next year.
Ben Adams
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