Sunday, June 2, 2013

Reuters: Regulatory News: Bayer's Nexavar shown to delay thyroid cancer by 5 months

Reuters: Regulatory News
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Bayer's Nexavar shown to delay thyroid cancer by 5 months
Jun 2nd 2013, 11:30

FRANKFURT, June 2 | Sun Jun 2, 2013 7:30am EDT

FRANKFURT, June 2 (Reuters) - Bayer said on Sunday its cancer drug Nexavar was shown to delay progression of a difficult-to-treat type of thyroid cancer by about five months, as the German drugmaker seeks to widen the use of the pill.

The indication, if approved by regulators, could mean up to 150 million euros ($196 million) in additional annual sales from the drug, which had 792 million euros in revenues last year, said Andreas Fibig, the head of Bayer's prescription drugs business.

The trial explored the use of Nexavar in patients with thyroid cancer that returned despite previous surgery and treatment with radioactive iodine, a group with a particularly poor prospect of survival.

In the late-stage study, presented at the American Society of Clinical Oncology in Chicago this weekend, patients on the Nexavar pill did not see their tumours worsen for a median 10.8 months, while the time to tumour progression in the control group on placebo was a median 5.8 months.

Bayer in January said Nexavar had reached the primary goal of the late-stage clinical trial.

It plans to file for approval of the new use with U.S. and European regulators as soon as possible.

Nexavar, developed jointly with Onyx Pharmaceuticals , is already approved to treat liver as well as kidney cancer and it is also being tested on breast cancer patients.

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