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Exelixis Gets FDA Approval For Its CABOMETYX Tablets

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Exelixis, Inc. (NASDAQ: EXEL) revealed the FDA has given its approval for its CABOMETYX (cabozantinib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. According to the company, RCC was the most common form of kidney cancer in adults. CABOMETYX, which was granted Fast Track and Breakthrough Therapy designations by the FDA, was the first therapy to showcase in a phase 3 trial for patients with advanced RCC, robust and clinically meaningful improvements in all three key efficacy parameters — overall survival, progression-free survival and objective response rate.

The company's President and CEO, Michale Morrissey, commented "With today's announcement, patients with previously treated advanced kidney cancer now have a new option, the first and only approved product demonstrated to help patients live longer while also delaying the progression of their cancer. We are proud to bring new hope to this community, who are looking for more therapies that can help extend lives. Exelixis is committed to making CABOMETYX available to patients in need within the next couple weeks."

Exelixis said, "The efficacy profile demonstrated by CABOMETYX in the METEOR trial, now complemented by the overall survival benefit, is highly compelling. CABOMETYX is distinct from other approved treatment options, as it targets multiple tyrosine kinases involved in the development of RCC, including MET, AXL and three VEGF receptors. At the same time, physicians are very familiar with this class of drug and how to use dose adjustments to balance safety and efficacy. The approval of CABOMETYX is wonderful news for physicians who are looking for a new option for their previously treated patients with advanced kidney cancer."

The approval of CABOMETYX was based on results of the phase 3 METEOR trial that met its primary endpoint of improving progression-free survival. The company stated that as announced earlier in February 2016, CABOMETYX demonstrated a statistically significant and clinically meaningful increase in overall survival in the METEOR trial.

Following the news, the stock traded higher by 4 percent.

Posted-In: Biotech News FDA General


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