The Lancet Publishes Phase III Trial Of Nevaxar For Thyroid Cancer
Bayer HealthCare and Onyx Pharmaceuticals, an Amgen subsidiary, announced that The Lancet published online results from its Phase III DECISION trial. Trial results showed that Nevaxar (sorafenib) tablets significantly extended the time patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment lived without their disease worsening (progression-free survival (PFS)).
“The Lancet publication will give healthcare providers greater insight into the DECISION trial. While the majority of differentiated thyroid cancers are treatable, patients who are no longer responding to standard therapies - including surgery and radioactive iodine - are more difficult to treat and have limited options. The DECISION trial demonstrates the activity of sorafenib for this type of differentiated thyroid cancer in patients with this challenging tumor,” said Marcia Brose, principal investigator of the DECISION trial and Assistant Professor in the Department of Otorhinolaryngology, Head and Neck Surgery in the Abramson Cancer Center and the Perelman School of Medicine at the University of Pennsylvania.
Thyroid cancer is the sixth most common cancer in women and has become one of the fastest-increasing cancers in recent years. Nearly 300,000 new cases of thyroid cancer are diagnosed annually. About 400,000 people die from thyroid cancer worldwide every year.
Sorafenib was co-developed by Onyx and Bayer for the treatment of a range of cancers. The drug approved in the U.S. for the treatment of patients with unresectable hepatocellular carcinoma, patients with advanced renal cell carcinoma, and patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment. Sorafenib is thought to inhibit both tumor cell and tumor vasculature, and is shown to inhibit multiple kinases crucial to cancer growth.
The companies said that the data from the DECISION trial formed the basis for the U.S. Food and Drug Administration (FDA) approval of Nevaxar in November 2013 for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.