Exelixis’ Cancer Drug Receives FDA Breakthrough Therapy Designation

August 28, 2015

Exelixis expects to submit an NDA by the end of this year for cabozantinib to treat advanced renal cell cancer, following the receipt of FDA breakthrough therapy designation for use in patients who have received one prior therapy.

The designation is based on results of a Phase 3 pivotal trial showing cabozantinib reduced the rate of disease progression or death by 42 percent in the RCC patients compared with everolimus.

Cabozantinib is now eligible for certain regulatory benefits, such as the involvement of FDA senior managers in the review process for this indication and the potential for priority review of the NDA.

The South San Francisco-based drugmaker is pursuing approval for a tablet form of cabozantinib, rather than the capsule form already approved in the U.S. and Europe to treat progressive, metastatic medullary thyroid cancer. Exelixis markets the capsule under the brand name Cometriq.

The FDA granted cabozantinib fast-track status in April as a second-line treatment for patients with advanced RCC.

Cabozantinib is also being assessed in a Phase 3 study of patients with advanced liver cancer. A variety of earlier-stage trials are ongoing as part of Exelixis’ collaboration with the National Cancer Institute’s cancer therapy evaluation program, as well as with the company’s investigator-sponsored trial program. — Jonathon Shacat