The EU's Committee for Medicinal Products for Human Use has recommended that Roche's Zelboraf be granted full marketing authorization to treat adults with BRAF V600 mutation-positive unresectable or metastatic melanoma. A final decision by the European Commission is expected in February.
Zelboraf, which was developed in collaboration with Plexxikon originally and now partnered with Daiichi Sankyo, has been tapped by analysts as a potential blockbuster and gives new hope to patients who previously had limited treatment options. This year, it became the first and only FDA- and Swissmedic-approved personalized medicine for people with this deadly type of skin cancer. The cobas 4800 BRAF V600 mutation test, co-developed by Roche, was approved at the same time as the drug in the U.S., and it is CE-marked in the EU. Zelboraf is designed to target and inhibit mutated forms of the BRAF protein found in about half of all cases of melanoma.
Metastatic melanoma is the deadliest and most aggressive form of skin cancer, as less than a quarter of the people diagnosed with it are alive 12 months post-diagnosis. Roche CMO Hal Barron said the company is working to get the drug approved by additional health authorities around the world. Regulatory submissions for Zelboraf are pending in a number of countries, including Australia, New Zealand, Brazil, India, Mexico and Canada.
Roche has been looking to dive deeper into the promising field of personalized medicine. As company CEO Severin Schwan (photo) explained to Reuters this year, targeted therapies can command a premium, even amid government pricing pressures.
- see Roche's release
- check out the CHMP's statement