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Nexavar Under FDA Review: Drug May Treat Thyroid Cancer


A valuable gift could be given to people who have thyroid cancer: a new treatment found to slow down the progression of the disease.

The oral drug Nexavar (sorafenib) is under Food and Drug Administration Priority Review to treat thyroid cancer, and the review should be completed by Dec. 25.

Developed by Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals Inc., the drug is currently used for treating forms of liver and kidney cancer. Now it could be used to treat people with thyroid cancer who no longer benefit from typical treatment.

Dr. Frederic Kaye, medical director of the thoracic oncology program at the University of Florida Health Cancer Center, said sorafenib comes from a family of drugs that tries to block the growth factor receptors of the cancer.

So far, the drug does not completely stop the cancer, but it can be used to slow the cancer growth.

He said sorafenib was found to improve progression-free survival in patients with papillary thyroid cancer. Progression-free survival is the length of time during and after cancer treatment that a patient lives with the cancer but it does not get worse.

Sorafenib prevented the cancer from spreading and growing over a period of time.

The drug increased this kind of survival to about 11 months in patients who were treated with it, and these results are now under review by the FDA. The survival period for patients in the placebo group was about four months shorter.

“It was a significant first step, but it’s just a first step,” Kaye said.

Although the number of papillary thyroid cancer cases has tripled in the U.S. over the past 30 years, the mortality rate over the past decade has been relatively flat, he said.

The increase in number of cases is mostly driven by the detection of small papillary tumors, he said. But, some of these tumors may not harm the patient.

“Overdiagnosis is a concern, but overtreatment of a small tumor could be even a greater worry,” he said. The overtreatment of patients could expose them to unnecessary and possibly harmful treatment.

Eva Page, a 42-year-old Gainesville woman diagnosed with thyroid cancer in 2010, said, “The incidence of thyroid cancer is one of the fastest growing, but a lot of that is because we have better ways of detecting it than we used to.”

In regards to Nexavar, Page is glad there may be another option out there.

Most people who are diagnosed with thyroid cancer are treated and cured with surgery, and some people are treated with radioiodine, she said.

“For those who don’t respond to that, it does give hope that there are other options available,” Page said.

Kevin Macolley was diagnosed in 2001 with medullary thyroid cancer and was on Nexavar (sorafenib) for about nine months. He taught as a college professor at ITT Technical Institute before he was diagnosed with thyroid cancer.
Kevin Macolley, who taught as a college professor at ITT Technical Institute before he was diagnosed with thyroid cancer.

Kevin Macolley, a 59-year-old member of Thyroid Cancer Survivors’ Association, was diagnosed with medullary thyroid cancer in September 2001. He was on Nexavar for about nine months.

He said Nexavar reduced his calcitonin, an indicator of the cancer and a hormone that is abundant in people with medullary thyroid cancer.

Higher levels of the hormone normally indicate the cancer is getting worse. But, the hormone is just an indicator of the cancer, and it is not harmful to the patient. Those with low or nonexistent levels of the hormone do not have medullary thyroid cancer.

Macolley said he responded severely to the side effects. He had blisters on his feet that prevented him from walking. Other side effects of Nexavar include high blood pressure and bleeding that could lead to death, according to the Nexavar website.

But, like chemotherapy, Nexavar didn’t last forever, he said.

“It just stops working,” he said. “The cancer finds a way to get around the roadblock.”

Macolley’s cancer spread to his liver, and he has gone through many different kinds of treatments to try to get rid of the disease that has taken a toll on his body.

Macolley has gone through surgery and has been on two other drugs following Nexavar in the past couple of years for his medullary thyroid cancer: Cometriq (cabozantinib) and Caprelsa (vandetanib).

He said with all these different drugs, he’s experienced side effects ranging from diarrhea to weight loss that resulted in him getting a feeding tube. Regardless, he said the drug bought him time he wouldn’t have had otherwise.

Macolley’s voice cracks in and out and he has shortness of breath. He once was a college professor at ITT Technical Institute, and he said he’d love to go back and teach students if he could.

Although these side effects may be severe, the drugs buy time for people who have thyroid cancer. It allows time for a new drug to be developed that may help treat the cancer or another new drug that prevents the disease from spreading.

“You look for a ray of sunshine wherever you can find it,” Macolley said.

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