Exelixis Inc.'s (EXEL) lead compound for medullary thyroid cancer, Cometriq, previously known as Cabozantinib, crossed the finish line on Thursday winning FDA approval.
Cometriq, wholly-owned by Exelixis, is said to work by blocking signaling that leads to cancer growth as well as blocking the growth of new blood vessels (angiogenesis) that help to feed a tumor.
Medullary thyroid cancer, one of the rarer types of thyroid cancers, is said to account for about 4 percent of thyroid cancers. According to the National Cancer Institute, 56,460 Americans will be diagnosed with thyroid cancer and 1,780 will die from the disease in 2012.
Cometriq is the second drug approved to treat medullary thyroid cancer after AstraZeneca plc's Caprelsa (Vandetanib) in the past two years said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, in a statement.
In clinical trials, patients treated with Cometriq lived an average of 11.2 months without tumor growth compared with an average of four months in patients who received a placebo. In addition, reduction in tumor size lasting an average of nearly 15 months was observed in 27 percent of patients treated with Cometriq while no such reduction was seen in placebo-treated patients, says the FDA.
Cometriq will carry a Boxed Warning alerting patients and health care professionals about the severe and fatal bleeding and holes (perforations and fistula) in the colon associated with its use.
EXEL closed Thursday's trading at $5.24, down 0.76%. The stock fell further in after-hours to $5.10.
by RTT Staff Writer
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