Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has granted fast track designation for Exelixis' cabozantinib to treat patients with advanced renal cell carcinoma (RCC) who have received one prior therapy.
Subscribe to our email newsletter
The company’s lead compound, cabozantinib, inhibits the activity of multiple tyrosine kinases including MET, VEGFRs and RET.
Currently, cabozantinib is being evaluated in an ongoing Phase III METEOR trial in patients with metastatic RCC who have experienced disease progression following treatment with at least one VEGFR tyrosine kinase inhibitor.
In the trial, patients are randomized 1:1 to receive cabozantinib 60mg daily or everolimus 10mg daily.
METEOR’s primary endpoint is progression-free survival, while secondary endpoints include overall survival and objective response rate.
The company intends to report top-line results from the trial in the second quarter of 2015.
Apart from metastatic RCC development program, the company is also evaluating cabozantinib in CELESTIAL, a Phase III pivotal trial in second-line hepatocellular carcinoma (HCC).