FDA Grants Fast Track Status to Exelixis’ Kidney Cancer Drug

The US Food and Drug Administration (FDA) has granted Fast Track designation to Exelixis’ renal cell carcinoma (RCC) drug.

The agency provided fast track status for Exelixis’ investigational cabozantinib for the treatment of patients with advanced RCC who have received one prior therapy. The news sent the company’s shares up more than ten percent early Thursday morning.

Cabozantinib is Exelixis’ lead compound, which inhibits the activity of multiple tyrosine kinases including MET, VEGFRs and RET. The drug is being evaluated in the late-stage METEOR trial, which is currently taking place in patients with metastatic RCC who have experienced disease progression following treatment with at least one VEGFR tyrosine kinase inhibitor. In the Phase III study, patients are randomized to receive 60 mg of cabozantinib daily or 10 mg of everolimus daily. The study’s primary endpoint is progression-free survival (PFS), and secondary endpoints include overall survival and objective response rate. According to the company, it expects to release top-line results in the second quarter of 2015.

Kidney cancer is among the top ten most commonly diagnosed forms of cancer among both men and women in the US, according to the American Cancer Society (ACS). Clear cell RCC is the most common type of kidney cancer in adults. If it is caught in its early stages, the five year survival rate for RCC is high, however, for patients with advanced or late-stage metastatic RCC, the five year survival rate is under 10 percent, with no identified cure for the disease.

In the second-line setting, four new therapies have been approved in the past five years. However, despite the availability of several therapeutic options, currently approved drugs have shown little differentiation in terms of efficacy and have demonstrated only modest PFS benefit in patients refractory to sunitinib, a commonly-used first-line therapy. There second-line setting encompasses approximately 11,000 drug-eligible patients in the US and 37,000 globally.

In addition to the metastatic RCC development program, Exelixis is also studying cabozantinib in a Phase III trial, known as CELESTIAL, in second-line hepatocellular carcinoma (HCC). Cabozantinib, marketed as Cometriq, is currently approved by the FDA for the treatment of progressive, metastatic medullary thyroid cancer (MTC).

Source: Exelixis, Inc.

Last updated: 4/10/15; 12:00pm EST


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