Bayer, Onyx receive FDA fast-track designation for Nexavar for advanced melanoma treatment

By Lisa Kerner

Charlotte, N.C., July 20 - Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals, Inc. said Nexavar (sorafenib) tablets were granted fast-track designation by the Food and Drug Administration for the treatment of advanced melanoma (skin cancer).

Nexavar, an oral multi-kinase inhibitor that targets tumor cells and tumor vasculature, is already FDA-approved for the treatment of patients with advanced renal cell carcinoma (RCC).

The fast-track designation expedites the drug review process and allows a company to file a New Drug Application on a rolling basis as data become available.

Bayer and Onyx began Prism, a phase 3, double-blind, randomized, placebo-controlled trial of Nexavar administered in combination with a standard dosing schedule (21-day cycles) of carboplatin (AUC 6) and paclitaxel (225 mg/m2).

The study of 250 patients will measure the safety and efficacy of Nexavar, with the primary endpoint of progression-free survival as its primary endpoint.

Another, similar phase 3 trial, sponsored by the Eastern Cooperative Oncology Group, is also underway to evaluate carboplatin, paclitaxel and Nexavar in patients with unresectable stage 3 or stage 4 melanoma.

Bayer is a Leverkusen, Germany-based pharmaceutical company.

Onyx, based in Emeryville, Calif., develops cancer therapies.

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