FDA approves clinical use of cabozantinib (but not for prostate cancer, yet)


The U.S. Food & Drug Administration (FDA) has approved cabozantinib (brand name Cometriq™) for treatment of progressive, metastatic medullary thyroid cancer in the USA.

The media release announcing the approval of cabozantinib for this clinical use is available on the Exelixis web site.

As at least some readers will be aware, cabozantinib is also in development for the treatment of metastatic, castration-resistant prostate cancer (mCRPC). Thus, the approval of cabozantinib in metastatic medullary thyroid cancer does make this drug potentially available for use off label in the treatment of men with mCRPC.

It should be noted immediately that use of cabozantinib in its approved indication is clearly associated with a number of potentially very serious side effects, including:

  • Serious and sometimes fatal gastrointestinal perforations and fistulas
  • Severe and sometimes fatal hemorrhage
  • Increased risk for thrombotic events, such as heart attacks.
  • Wound complications

Whether US insurance companies or Medicare will be willing to cover the costs of the use of cabozantinib for the treatment of mCRPC off label is not a question to which we have any answer at this time, and the best way to get access to cabozantinib at this time may still be to enroll in one of the ongoing clinical trials of this drug in the treatment of late stage prostate cancer. However, the approval of this drug in a non-prostate cancer indication is another good signal for the possible future approval of this drug in very late stage prostate cancer too.

For our European readers, it is worth noting that Exelixis was also able to announce that the European Medicines Agency (EMEA) has accepted the Marketing Authorization Application (MAA) for cabozantinib for review for the treatment of progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer. It is therefore possible that cabozantinib will also become available in Europe in the not to distant future (albeit not approved for the treatment of late stage prostate cancer).

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