Back to top

Image: Bigstock

Exelixis (EXEL) Wins FDA Nod for Cabometyx + Opdivo in RCC

Read MoreHide Full Article

Exelixis, Inc. (EXEL - Free Report) and partner Bristol-Myers Squibb Company (BMY - Free Report) announced that the FDA approved the former’s lead drug, Cabometyx, in combination with the latter’s immuno-oncology drug, Opdivo, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The approval came ahead of the Prescription Drug User Fee Act action date of Feb 20, 2021.

The FDA approval was based on positive results of the CheckMate -9ER study, wherein the combination of Cabometyx and Opdivo significantly improved overall survival while doubling progression-free survival and objective response rate compared to Pfizer’s (PFE - Free Report) Sutent as a first-line treatment for patients with advanced RCC, one of the most common forms of kidney cancer.

The approval will be a significant boost for Cabometyx. This market represents huge potential, as an estimated 15,000 patients with advanced RCC are eligible for first-line treatment every year in the United States, with immune checkpoint inhibitor (ICI) combination therapy consisting of approximately 80% of that market.

Of late, the focus in this space has shifted to combination treatment as the first-line option for RCC patients. Given its market potential, most pharma/biotech bigwigs are scurrying to grab a larger chunk of this pie.

Merck’s (MRK - Free Report) immuno-oncology drug, Keytruda, plus Inlyta is also approved for the first-line treatment of patients with advanced RCC.

We remind investors that the tablet formulation of cabozantinib is approved as Cabometyx in the United States for the treatment of patients with advanced RCC and those with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar.

Shares of the company have increased 24.8% in the past year compared with the industry’s growth of 18.1%. Shares gained 3.8% on the news.

Meanwhile, the company plans to evaluate Cabometyx further for additional indications. Revenues generated from approved indications of the drug are expected to support its pipeline progress.

Exelixis currently carries a Zacks Rank #4 (Sell). 

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Just Released: Zacks’ 7 Best Stocks for Today

Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.4% per year.

These 7 were selected because of their superior potential for immediate breakout.

See these time-sensitive tickers now >>