We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Exelixis' (EXEL) Applications for Cabometyx-Opdivo Combo Accepted (Revised)
Read MoreHide Full Article
Exelixis, Inc. (EXEL - Free Report) and partner Bristol Myers Squibb (BMY - Free Report) announced that the FDA has accepted the supplemental Biologics License Application (sBLA) and supplemental New Drug Application (sNDA), respectively, for the combination of the former’s Cabometyx (cabozantinib) in combination with the latter’s immuno-oncology drug, Opdivo (nivolumab).
The applications are seeking approval for the combination in patients with advanced renal cell carcinoma (RCC).
The regulatory body has granted Priority Review to both applications and assigned a Prescription Drug User Fee Act (PDUFA) goal date of Feb 20, 2021.
Positive results from the phase III CheckMate -9ER study formed the basis of the filings. The study evaluated the combination in patients with previously untreated advanced RCC compared to Pfizer’s (PFE - Free Report) Sutent (sunitinib).
Results showed that the combination demonstrated significant improvements across all efficacy endpoints, including overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to Sutent.
Both drugs are already approved for RCC and the combination, if approved, will provide another option to patients seeking an immunotherapy plus tyrosine kinase inhibitor regimen.
Exelixis’ shares have rallied 22.9% year to date against a 4.9% decline for the industry.
Cabometyx generated sales of $362.8 million in the first half of 2020. The uptake of the drug, since its approval has been strong. The company’s efforts to develop Cabometyx for various other indications are also encouraging. Label expansion of the drug for additional indications should further boost sales.
Of late, the focus in this space has shifted to checkpoint inhibitor-containing regimens in combination with a TKI 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.
Last year, the FDA approved Merck’s (MRK - Free Report) immuno-oncology drug, Keytruda, plus Inlyta for the first-line treatment of patients with advanced RCC.
Image: Bigstock
Exelixis' (EXEL) Applications for Cabometyx-Opdivo Combo Accepted (Revised)
Exelixis, Inc. (EXEL - Free Report) and partner Bristol Myers Squibb (BMY - Free Report) announced that the FDA has accepted the supplemental Biologics License Application (sBLA) and supplemental New Drug Application (sNDA), respectively, for the combination of the former’s Cabometyx (cabozantinib) in combination with the latter’s immuno-oncology drug, Opdivo (nivolumab).
The applications are seeking approval for the combination in patients with advanced renal cell carcinoma (RCC).
The regulatory body has granted Priority Review to both applications and assigned a Prescription Drug User Fee Act (PDUFA) goal date of Feb 20, 2021.
Positive results from the phase III CheckMate -9ER study formed the basis of the filings. The study evaluated the combination in patients with previously untreated advanced RCC compared to Pfizer’s (PFE - Free Report) Sutent (sunitinib).
Results showed that the combination demonstrated significant improvements across all efficacy endpoints, including overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to Sutent.
Both drugs are already approved for RCC and the combination, if approved, will provide another option to patients seeking an immunotherapy plus tyrosine kinase inhibitor regimen.
Exelixis’ shares have rallied 22.9% year to date against a 4.9% decline for the industry.
Cabometyx generated sales of $362.8 million in the first half of 2020. The uptake of the drug, since its approval has been strong. The company’s efforts to develop Cabometyx for various other indications are also encouraging. Label expansion of the drug for additional indications should further boost sales.
Of late, the focus in this space has shifted to checkpoint inhibitor-containing regimens in combination with a TKI 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.
Last year, the FDA approved Merck’s (MRK - Free Report) immuno-oncology drug, Keytruda, plus Inlyta for the first-line treatment of patients with advanced RCC.
Exelixis currently carries a Zacks Rank #4 (Sell), while Bristol-Myers currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
(We are reissuing this article to correct a mistake. The original article, issued on October 20, 2020, should no longer be relied upon.)