FDA Approves NEXAVAR (Sorafenib)

Bayer HealthCare and Onyx Pharmaceuticals, Inc., an Amgen subsidiary, have announced that FDA has approved a supplemental New Drug Application for the oral multi-kinase inhibitor NEXAVAR (sorafenib) tablets for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment. NEXAVAR was approved following a priority review by FDA, a designation reserved for drugs that may offer a significant improvement in treatment over existing options.

"Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment is difficult to treat," said Pamela A. Cyrus, MD, Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. "NEXAVAR is the first and only FDA-approved therapy for this type of thyroid cancer and is a positive development for patients who previously had limited treatment options."

"We are pleased to be able to offer NEXAVAR as a treatment option for patients with thyroid cancer who are no longer responding to standard therapy," said Pablo J. Cagnoni, MD, President, Onyx Pharmaceuticals, Inc. "We are committed to making this treatment available to physicians and their patients as quickly as possible."

"An unmet medical need exists for this type of thyroid cancer, underscoring the need for new therapies," said Gary Bloom, Executive Director of ThyCa: Thyroid Cancer Survivors' Association, Inc. "We are excited that an FDA-approved treatment is now available to patients coping with this challenging type of thyroid cancer."