Market Overview

Phase 3 DECISION Trial of Nexavar Meets Primary Endpoint

Bayer HealthCare Pharmaceuticals (OTC: BAYRY) and Onyx Pharmaceuticals (NASDAQ: ONXX) today announced that a Phase 3 trial of Nexavar® (sorafenib) tablets in patients with locally advanced or metastatic radioactive iodine-refractory (RAI) differentiated thyroid cancer has met its primary endpoint of a statistically significant improvement of progression-free survival. The study, called DECISION, evaluated the efficacy and safety of Nexavar compared to placebo. Adverse events were generally consistent with the known profile for Nexavar. Data from this study are expected to be presented at an upcoming medical meeting.

"These results demonstrate Nexavar's activity in patients with RAI-refractory locally advanced, or metastatic differentiated thyroid cancer," said Dimitris Voliotis, M.D., Vice President, Global Clinical Development Oncology, Bayer HealthCare. "These types of thyroid cancer are difficult to treat and are associated with a poor prognosis."

"Effective treatment options are urgently needed for patients with radioactive iodine-refractory differentiated thyroid cancer," said Barbara Klencke, M.D., Senior Vice President, Clinical Development at Onyx Pharmaceuticals. "We are pleased that the results of this study demonstrate that Nexavar may provide a treatment option for these patients."

The companies anticipate that this data will form the basis for regulatory submission of Nexavar in the treatment of RAI-refractory differentiated thyroid cancer.

Posted-In: News FDA Global Pre-Market Outlook

 

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