The European Medicines Agency (EMA) has recommended the marketing authorisation of Roche’s drug Zelboraf (vemurafenib) as a treatment for metastatic or inoperable melanoma with BRAF V600 mutations.
The drug, a protein-kinase inhibitor, improves survival times in patients with advanced skin cancer by about three months relative to the standard existing treatment.
Zelboraf is a personalised medicine linked to Roche’s cobas BRAF Mutation Test, which selects patients for treatment with a number of specific anti-melanoma drugs.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Zelforaf outweighed the risk of causing secondary skin cancers, including squamous cell carcinomas.
While early-stage melanoma can be treated effectively by surgery, metastatic melanoma causes 15,000 deaths worldwide each year. Only a quarter of patients survive beyond 12 months.
In clinical trials, Zelboraf was found to improve progression-free survival times by around four months and overall survival times by about three months relative to the standard treatment (dacarbazine).
The CHMP decided that the risks of using Zelboraf were acceptably low, and that Roche had put in place an appropriate risk management procedure for doctors, including monitoring and treatment of secondary cancers.
Paul Brown, Head of Roche Molecular Systems, commented: “The cobas BRAF Mutation Test has improved sensitivity, accuracy and speed compared to other commonly used, unapproved detection methods. With a personalised medicine now available, all people diagnosed with inoperable or metastatic melanoma should be tested to help determine the best options for treatment.”
Zelboraf was approved by the FDA in August 2011.