Roche's Zelboraf and companion diagnostic for late-stage melanoma cleared in USA

Swiss drug major Roche (ROG: SIX) yesterday received US Food and Drug Administration approval for Zelboraf (vemurafenib) in the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma, as determined by an FDA-approved test. The news saw Roche’s shares gain 1.8% to 133.70 Swiss francs in afternoon trading in Zurich.

The FDA also cleared the cobas 4800 BRAF V600 Mutation Test, a diagnostic test developed by Roche to identify patients eligible for treatment. Zelboraf is the first and only FDA-approved personalized medicine shown to improve survival in people with BRAF V600E mutation-positive metastatic melanoma, demonstrating the benefits of Roche’s personalized health care approach, the company noted. It is designed to target and inhibit some mutated forms of the BRAF protein found in about half of all cases of melanoma, the deadliest and most aggressive form of skin cancer.

Zelboraf will be available in the USA within two weeks of approval. Roche has also submitted new drug applications for Zelboraf in the European Union, Switzerland, Australia, New Zealand, Brazil, India, Mexico and Canada. While Roche seeks regulatory approval of Zelboraf in other countries, a global Expanded Access Program (EAP) is available for people with previously treated or untreated BRAF V600 mutation-positive metastatic melanoma.