Exelixis, Inc. (NASDAQ:EXEL) announced that the U.S. Food and Drug Administration (FDA) has approved CABOMETYX™ (cabozantinib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. RCC is the most common form of kidney cancer in adults. CABOMETYX, which was granted Fast Track and Breakthrough Therapy designations by the FDA, is the first therapy to demonstrate 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.

“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,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “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.”

“The efficacy profile demonstrated by CABOMETYX in the METEOR trial, now complemented by the overall survival benefit, is highly compelling,” said Toni Choueiri, MD, Clinical Director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute. “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 is based on results of the phase 3 METEOR trial, which met its primary endpoint of improving progression-free survival. Compared with everolimus, a standard of care therapy for second-line RCC, CABOMETYX was associated with a 42 percent reduction in the rate of disease progression or death. Median progression-free survival for cabozantinib was 7.4 months versus 3.8 months for everolimus (HR=0.58, 95% CI 0.45-0.74, P<0.0001). CABOMETYX also significantly improved the objective response rate compared with everolimus. These data were presented at the European Cancer Congress in September 2015 and published in The New England Journal of Medicine. (Original Source)

Shares of Exelixis are up nearly 4% to $4.85 in pre-market trading. EXEL has a 1-year high of $6.81 and a 1-year low of $2.51. The stock’s 50-day moving average is $4.12 and its 200-day moving average is $4.83.

On the ratings front, Exelixis has been the subject of a number of recent research reports. In a report issued on April 15, Cowen analyst Eric Schmidt maintained a Buy rating on EXEL. Separately, on April 4, Stifel Nicolaus’ Prakhar Verma upgraded the stock to Buy and has a price target of $7.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Eric Schmidt and Prakhar Verma have a total average return of 15.6% and 14.9% respectively. Schmidt has a success rate of 52.9% and is ranked #131 out of 3828 analysts, while Verma has a success rate of 100.0% and is ranked #2219.

Exelixis, Inc. is a biopharmaceutical company, which engages in the developing and commercializing small molecule therapies for the treatment of cancer. Its two advanced assets are COMETRIQ and cobimetinib. The company focuses on their proprietary resources and development and commercialization of cabozantinib. Exelixis was founded by Corey S. Goodman and Stelios B. Papadopoulos on November 15, 1994 and is headquartered in South San Francisco, CA.