Please ensure Javascript is enabled for purposes of website accessibility

Exelixis Gets FDA Approval for Cabometyx in Combination Therapy for Front-Line RCC

By Eric Volkman - Jan 22, 2021 at 7:44PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The regulator's nod represents an important expansion for the drug.

Exelixis (EXEL 1.83%) is charging into the weekend on a high note. On Friday, the company announced that the Food and Drug Administration approved its drug Cabometyx (also known as Cometriq) for first-line treatment of patients with advanced renal cell carcinoma (RCC), in combination with Bristol Myers Squibb's (BMY 0.30%) Opdivo.

The approval is a big win for Exelixis, as RCC is the most common form of kidney cancer. The company also pointed out that it is among the top 10 most diagnosed cancers in the U.S.

Medical professionals conferring in a hospital lobby.

Image source: Getty Images.

The approval cycles of Cabometyx and Opdivo closely align. The Bristol Myers Squibb drug was approved by the FDA as a second-line treatment for RCC in late 2015. Cabometyx was given its green light for the same indication the following April.

The drug's approval derives from a comparative study on the effects of a Cabometyx/Opdivo combination versus sunitinib -- marketed by Pfizer under the brand name Sutent. The drugs were put through their paces in a phase 3 clinical trial aimed at evaluating their effect on previously untreated advanced or metastatic RCC.

"As the only combination treatment regimen to double median progression-free survival and objective response rate compared with sunitinib while also significantly improving overall survival, we are excited that Cabometyx in combination with Opdivo is now available for the first-line treatment of patients with advanced kidney cancer," said Exelixis CEO Michael Morrissey.

Both Exelixis and Bristol Myers Squibb stock increased on the news, although the latter had a more modest rise. Exelixis closed Friday nearly 3.9% higher, against the 0.3% decline of the S&P 500 index, while its peer enjoyed a 0.6% bump on the day.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Exelixis, Inc. Stock Quote
Exelixis, Inc.
EXEL
$17.76 (1.83%) $0.32
Bristol Myers Squibb Company Stock Quote
Bristol Myers Squibb Company
BMY
$76.19 (0.30%) $0.23

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning service.

Stock Advisor Returns
330%
 
S&P 500 Returns
115%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 05/21/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.