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FDA grants priority review for Nexavar for treatment of thyroid cancer
The FDA has granted priority review status to the oral multikinase inhibitor sorafenib for the treatment of locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer.
“We are very pleased that the FDA has chosen to grant Priority Review to sorafenib,” Pamela A. Cyrus, MD, vice president and head of US medical affairs at Bayer HealthCare Pharmaceuticals, said in a press release. “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.”
The FDA granted priority review to sorafenib (Nexavar, Bayer Healthcare) based on initial results of the DECISION trial, an international, multicenter, placebo-controlled study.
The study included 417 patients with locally advanced or metastatic, radioactive iodine-refractory, differentiated thyroid cancer who had not received any prior chemotherapy, tyrosine kinase inhibitors, monoclonal antibodies that target VEGF or VEGF receptor.
Patients were randomly assigned 400 mg oral sorafenib twice daily (n=207) or matching placebo (n=210).
The primary endpoint of the study was PFS, as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Secondary endpoints included OS, time to progression, response rate and duration of response. The study also assessed safety and tolerability.
“Sorafenib could offer an FDA-approved treatment option for patients with this type of thyroid cancer,” Pablo J. Cagnoni, MD, executive vice president of global research and development and technical operations at Onyx Pharmaceuticals, said in a press release.
Perspective
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Sorafenib shows efficacy in advancing thyroid cancer and can be best utilized when you know the metabolic pathway of the tumor. It can slow tumor growth and have an associated fall in thyroglobulin, showing that you’ve inhibited the metabolic activity of the tumor. Sorafenib and other tyrosine kinase inhibitors are not curative, but when correctly administered for definable advancing or aggressive thyroid cancer refractory to other types of therapy, they can be palliative. They can extend life and relieve morbidity. They’re helpful adjunct-wise to shrink the tumor and block the tumor from growing and causing bone pain. These drugs are best administered by oncologists, or a team that includes oncologists, endocrinologists or others dealing with advancing cancer. Well-known side effects include fatigue, gastrointestinal distress, generalized aching, skin disorders, liver dysfunction and secondary skin cancers, all of which can occur during the course of therapy with a TKI.
Overall, sorafenib was moderately well tolerated and showed statistical significance in a clinical trial on tumor growth rates. It can carry patients for as short as 6 months to sometimes as long as 2 years or more from clinical observations. The availability of performing biopsy and tissue tumor biomarker sequencing on the advancing tumor is better than the administration of a drug such as sorafenib known to work in general on metabolic pathways to thyroid cancer tumors. Then you can actually determine if you’re going to have a more successful drug trial rather than a shotgun approach to see how it does and see how it works. So if there’s tumor accessible, it’s always good in this situation before you put them on any TKI drug for advancing cancer.
This is an important step forward. This will be one of the first TKIs that potentially will have FDA approval for advancing thyroid cancer.