Bayer, Onyx granted orphan drug status for liver cancer drug Nexavar

By Elaine Rigoli

Tampa, Fla., April 26 - Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals, Inc. announced Wednesday that Nexavar (sorafenib) tablets have been granted orphan drug status for the treatment of hepatocellular carcinoma, or liver cancer, by the Food and Drug Administration.

A similar designation has been granted by the European Commission.

In a phase 2 single agent study, 43% of patients treated with Nexavar experienced stable disease for at least four months and an additional 9% of patients experienced tumor shrinkage, according to a news release.

A phase 3 trial of Nexavar administered as a single agent is ongoing, the release said.

The trial is designed to measure differences in overall survival, time-to-symptom progression and time-to-tumor progression of Nexavar versus a placebo in liver cancer patients.

A randomized phase 2 trial for liver cancer patients to evaluate the efficacy of Nexavar in combination with the chemotherapeutic agent doxorubicin is also ongoing.

Emeryville, Calif.-based Onyx is engaged in the development of novel cancer therapies that target the molecular basis of cancer.

Bayer Pharmaceuticals, based in West Haven, Conn., is part of the worldwide operations of Bayer HealthCare AG.

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