FDA clears Bayer, Onyx Pharmaceuticals’ Nexavar for late-stage differentiated thyroid cancer

The FDA on Friday approved Bayer and Onyx Pharmaceuticals’ Nexavar (sorafenib) for the treatment of patients with late-stage differentiated thyroid cancer. Pamela A. Cyrus, head of US medical affairs for Bayer, remarked « 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. »

The approval was supported by a study involving 417 patients with radioactive iodine-refractory locally recurrent or metastatic, progressive differentiated thyroid cancer. Study data showed that the therapy extended progression-free survival by 41 percent, as patients treated with Nexavar displayed a progression-free survival of 10.8 months, versus 5.8 months for the placebo arm.

Nexavar gained expanded US approval for the treatment of late-stage differentiated thyroid cancer under the FDA’s priority reviewprogramme. The drug was previously approved for the treatment of advanced kidney cancer and for advanced liver cancer.

Onyx was acquired by Amgen earlier this year for $10.4 billion, granting the latter rights to Nexavar.

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