FDA approves Exelixis' Cometriq for rare thyroid cancer, as EMA accepts filing

30 November 2012

There were two items of good news yesterday for US drug developer Exelixis’ (Nasdaq: EXEL), the first being that the US Food and Drug Administration approved Cometriq (cabozantinib) to treat medullary thyroid cancer (MTC) that has spread to other parts of the body (metastasized), which will be the first product for the company to comer to market.

However, the prescribing information for Cometriq includes a Boxed Warning alerting patients and health care professionals that severe and fatal bleeding and holes (perforations and fistula) in the colon occurred in some patients.

The National Cancer Institute estimates that 56,460 Americans will be diagnosed with thyroid cancer and 1,780 will die from the disease in 2012. About 4 percent of thyroid cancers are medullary thyroid cancer, making it one of the rarer types of thyroid cancers.

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