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Home Industry News Roche applies for approval of new melanoma drug

Roche applies for approval of new melanoma drug

12th May 2011

Roche has submitted applications in the EU and US for approval of an innovative new treatment option for metastatic melanoma.

The company is seeking approval from both the European Medicines Agency and US Food and Drug Administration for vemurafenib, which is designed for patients with BRAF V600 mutation-positive forms of the skin cancer.

Data from two clinical trials has shown the potential efficacy of the drug, with trial subjects identified with the use of the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic system developed by Roche.

The company is also seeking to register this test in both territories.

Dr Hal Barron, chief medical officer and head of global product development at Roche, said these submissions are "exciting steps toward our goal of delivering a personalised therapy for this disease".

Last month, the company published its financial results for the first quarter of 2011, during which it saw strong sales of drugs such as Lucentis, Herceptin and MabThera.ADNFCR-8000103-ID-800529337-ADNFCR

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