FDA approves Nexavar for Thyroid Cancer-Bayer HealthCare/Onyx Pharma

The FDA has approved a supplemental New Drug Application for the oral multi-kinase inhibitor Nexavar (sorafenib), from Bayer HealthCare/Onyx Pharma, 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 the FDA, a designation reserved for drugs that may offer a significant improvement in treatment over existing options.

The FDA approval is based on the results of the DECISION trial, an international, multicenter, placebo-controlled study which showed treatment significantly extended progression-free survival (PFS), the primary endpoint of the study. The median PFS was 10.8 months among patients treated with sorafenib compared to 5.8 months among patients receiving placebo. The most common adverse reactions reported were: Palmar-plantar erythrodysesthesia syndrome (PPES) (69% vs. 8% placebo), diarrhea (68% vs. 15%) and alopecia (67% vs. 8%).