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FDA grants fast track status to Cometriq for advanced renal cell carcinoma
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The FDA granted fast track status to cabozantinib for the treatment of patients with advanced renal cell carcinoma who have received one prior therapy, according to a press release from the drug’s manufacturer.
Cabozantinib (Cometriq, Exelixis) inhibits the activity of MET, VEGF receptors and RET tyrosine kinases, which are involved in normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis and tumor microenvironment maintenance.
The drug is currently being evaluated in METEOR — an ongoing phase 3 pivotal trial — which includes patients with metastatic renal cell carcinoma who have experienced disease progression following treatment with at least one VEGF receptor tyrosine kinase inhibitor. Patients in this trial are randomized 1:1 to receive 60 mg daily cabozantinib or 10 mg daily everolimus (Afinitor, Novartis).
The primary endpoint of the METEOR trial is PFS. Secondary endpoints include OS and objective response rate.
Exelixis plans to release top-line results from the METEOR trial during the second half of 2015.
Cabozantinib — which is currently FDA approved for progressive, metastatic medullary thyroid cancer — also is being evaluated in the phase 3 CELESTIAL trial for patients with second-line hepatocellular carcinoma.