Exelixis, Inc. EXEL and partner Bristol Myers Squibb BMY 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 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 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.)
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