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Exelixis’ cabozantinib granted Fast Track designation by FDA for advanced renal cell carcinoma

Posted: 9 April 2015 |

Exelixis has announced that the FDA has granted Fast Track designation to cabozantinib for treatment of patients with advanced renal cell carcinoma…

Exelixis

Exelixis has announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation to cabozantinib for treatment of patients with advanced renal cell carcinoma (RCC) who have received one prior therapy.

Exelixis

Clear cell renal cell carcinoma is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for RCC is high; however, the five-year survival rate for patients with advanced or late-stage metastatic RCC is under 10 percent, with no identified cure for the disease.

Cabozantinib is the company’s lead compound and inhibits the activity of multiple tyrosine kinases including MET, VEGFRs and RET. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumour angiogenesis, and maintenance of the tumour microenvironment.

The FDA created the Fast Track process to facilitate the development and expedite the review of drugs to treat serious diseases and address unmet medical needs. Fast Track designation confers important benefits, including the potential eligibility for Priority Review of a New Drug Application, if relevant criteria are met.

Exelixis expects to release top-line results from Phase 3 trial in 2015 Q2

Cabozantinib is the subject of METEOR, an ongoing Phase 3 pivotal trial in patients with metastatic RCC who have experienced disease progression following treatment with at least one VEGFR tyrosine kinase inhibitor. Patients are randomized 1:1 to receive 60 mg of cabozantinib daily or 10 mg of everolimus daily. The primary endpoint of METEOR is progression-free survival, and secondary endpoints include overall survival and objective response rate. Exelixis expects to release top-line results from the trial in the second quarter of 2015. In addition to the metastatic RCC development programme, Exelixis is also evaluating cabozantinib in CELESTIAL, a phase 3 pivotal trial in second-line hepatocellular carcinoma (HCC).

For more information about Exelixis, Inc., please visit www.exelixis.com.