Bayer’s Nexavar May Get FDA Approval for Thyroid Cancer

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sorafenib-productNexavar (Sorafenib) is drug that is manufactured by Bayer and is used to treat renal cell cancer and Hepatocellular carcinoma (HCC). Depending on the individual patient and his or her medical history situation, the drug is prescribed for kidney and liver cancer and helps slow the growth and progression of the cancer. Latest research that shows the drug is effective in certain cases of thyroid cancer has prompted Bayer to file for FDA approval for the drug to treat thyroid cancer.

How Nexavar works

Nexavar is a targeted therapy drug and works as a tyrosine kinase inhibitor, angiogenesis inhibitor and VEGF inhibitor.  This oral drug works by blocking tumor cell growth using different methods:  it targets enzymes on the surface and within of cancer cells. These targets are possibly involved in angiogenesis (making of blood vessels).  Like other targeted therapy drugs for cancer, Nexavar has to be used with caution and has many side effects including heart problems. However, as thyroid cancer that has spread has basically no cure, Nexavar shows great promise in proving an effective treatment, increasing surviving rates.

Research study on Nexavar to treat thyroid cancer

The Phase III DECISION (study of sorafEnib in loCally advanced or metastatic patientS with radioactive Iodine refractory thyrOid caNcer) trial involved 417 patients with advanced or metastatic thyroid cancer who had not received any other chemotherapy were divided into two groups. A little less than half the patients (207) were given 400 mg. of sorafenib orally daily in two divided doses while the other group received a placebo.

This international, multicenter, placebo-controlled trial concluded that sorafenib significantly extended progression-free survival (PFS), the primary endpoint of the study when compared to patients on a placebo. In real terms it suggests a 41 percent reduction in the risk of progression or death for patients who received sorafenib compared to placebo-treated patients. The results were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2013.

Research results allow Bayer to apply for a priority review

The FDA has granted priority review designation to the Supplemental New Drug Application (sNDA) for Nexavar  tablets, for the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer. This means that it may approve the drug for use against thyroid cancer in six months against the usual time period of ten months.

According to Medical News Today, thyroid cancer is the sixth most common cancer in females. Over 213,000 new thyroid cancer diagnoses are made annually and 30,000 people die from the disease each year globally. While the majority of thyroid cancer cases can be treated by surgery and radioactive iodine therapy, about 10 percent do not respond to this line of treatment and develop metastatic cancer instead. The tumors then spread to the lungs, bones, nodes and other places in the body. There is no effective therapy to treat this cancer spread as the only other medicine available is Doxirubicin, but it is not effective and very toxic as well, so is rarely prescribed.

As such, the FDA approval of Nexavar will help patients of this kind of thyroid cancer. Since the drug is already on the market, the FDA approval will permit patients to legally get this drug if they have this kind of thyroid cancer. Bayer is also carrying out trials for the use of Nexavar to treat breast cancer.