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Bayer wins approval for expanded use of cancer drug Nexavar

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Bayer HealthCare's oncology franchise has received a boost with regulatory approval of Nexavar, a drug that treats an advanced and potentially fatal form of thyroid cancer.

The Food and Drug Administration last week approved the new indication for Nexavar, which is already approved to treat liver and kidney cancer. The partners submitted the application this summer.

Nexavar, co-marketed with Bayer and Calif.-based Onyx Pharmaceuticals Inc., targets a late-stage form of the disease — called advanced differentiated thyroid cancer — that does not respond well to radioactive iodine therapy, the standard treatment effective in most cases.

Nexavar's label expansion marks the fourth approval in 14 months for the oncology franchise of Bayer, a company historically known for making aspirin. The German pharmaceutical with New Jersey operations branched into cancer treating drugs in 2005.

Bayer expects the approval will lead to the further growth of Nexavar, which reported third-quarter sales of $277 million.

"We don't speculate on revenue but clearly there is a tremendous amount of momentum with the oncology business at Bayer," said Shannon Campbell, vice president and general manager of the company's oncology business.

Thyroid cancer is a cancerous growth of the thyroid gland in the neck. Nexavar works by inhibiting multiple proteins in cancer cells, limiting cell growth and division.

Campbell said about 60,000 news cases of thyroid cancer are diagnosed in the United States each year but most respond well to radioactive iodine therapy. Nexavar targets the 3,000 to 4,000 of cases that do not, she said.

"An unmet medical need exists for this type of thyroid cancer, underscoring the need for new therapies," Gary Bloom, executive director of Thyroid Cancer Survivors' Association Inc., said in a statement.

The new use was approved after clinical studies of 417 patients with advanced differentiated thyroid cancer.

The FDA said Nexavar increased the length of time patients lived without the cancer progressing by 41 percent compared with those receiving a placebo. Half of patients receiving Nexavar lived without cancer progression for at least 10.8 months compared to at least 5.8 months for participants receiving a placebo, the FDA said.

"Nexavar is the first and only FDA approved therapy for this type of thyroid cancer and is a positive development for patients who previously had limited treatment options," said Dr. Pamela Cyrus, vice president and head of U.S. Medical Affairs at Bayer HealthCare.

About 213,000 new cases of thyroid cancer are diagnosed globally each year, resulting in about 35,000 deaths annually, the company said.

Bayer HealthCare earlier this year centralized its New Jersey and New York operations to one location in the Whippany section of Hanover.


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