Nexavar Gets FDA Nod for Thyroid Cancer

Sorafenib granted FDA Priority Review designation for supplemental NDA

(RxWiki News) Most thyroid cancers are treatable, even curable. However, as with most cancers, once spreading (metastasis) begins, tumors are more difficult to treat. A medication is being evaluated to strengthen the arsenal against advanced thyroid cancer.

Nexavar (sorafenib) is being fast-tracked for US Food and Drug Administration (FDA) approval for the treatment of locally advanced or metastatic thyroid cancer that does not respond to radioactive iodine.

"Ask your pharmacist about new medications for your condition."

The FDA has granted Priority Review designation to the supplemental New Drug Application for Nexavar, which is already approved to treat liver and advanced kidney cancers.

The Priority Review designation is given to drug candidates that could offer significantly better treatment options than existing medications.

Nexavar is being evaluated to treat locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer. 

Differentiated thyroid cancers make up about 94 percent of all thyroid cancers and include papillary, follicular, Hürthle cell and poorly differentiated types of thyroid cancer.

Surgery is usually the first line of treatment for these types of cancer. Radioactive iodine therapy is commonly used to kill cancer cells that weren't removed during surgery or cells that may have spread beyond the thyroid.  

Thyroid cancer, which is more common in women than in men, will be diagnosed in just over 60,000 Americans this year.

The FDA granted this accelerated review based on the international DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial, which has so far demonstrated that Nexavar extends progression-free survival, which is a period during which the cancer does not get worse.

Nexavar is what’s known as an "oral multiple kinase inhibitor," which interferes with the mechanisms that help cancer cells grow. 

"This is an important milestone for sorafenib and the designation highlights the urgent need for new treatments for patients with this type of thyroid cancer who have limited or no treatment options,” said Pamela A. Cyrus, MD, Vice President and Head of US Medical Affairs for Bayer HealthCare Pharmaceuticals.

Nexavar is manufactured and marketed by Onyx Pharmaceuticals and Bayer.

The FDA review of Nexavar will be completed by December 13, 2013.

Review Date: 
September 3, 2013