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Exelixis (EXEL) Partner Gets EC Nod for Cabometyx + Opdivo

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Zacks Equity Research
·3 min read
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Exelixis, Inc. EXEL announced that its partner Ipsen clinched an approval from the European Commission (EC) for the combination of the lead drug of the former, Cabomteyx (cabozantinib), and Bristol Myers’ BMY immuno-oncology drug Opdivo as a first-line treatment for advanced renal cell carcinoma (RCC).

The EC nod was based on impressive results of the phase III CheckMate -9ER pivotal study wherein the combination regimen doubled progression-free survival (PFS) and the objective response rate (ORR) while significantly improving overall survival (OS) from Pfizer’s PFE Sutent, which is commonly used for RCC. The combination regimen was generally well tolerated.

We remind investors that Cabometyx is already approved in the European Union as a monotherapy for the treatment of advanced RCC in adults who already received prior VEGF-targeted therapy for previously untreated intermediate- or poor-risk advanced RCC and for addressing hepatocellular carcinoma (HCC) in adults who were previously treated with sorafenib.

In January 2021, the FDA approved Cabomteyx in combination with Opdivo for the first-line treatment of advanced RCC.

Shares of the company have increased 38.2% in the past year compared with the industry’s growth of 15.7%.

Per estimates, approximately 32,000 patients in the United States and 71,000 patients worldwide will require a systemic treatment for advanced kidney cancer in 2021.

The approval of the combination regimen should give a significant boost to sales given its market potential.

The advanced RCC treatment landscape evolved in recent times and the focus shifted to immunotherapy-VEGF TKI combinations in earlier-line treatment. Most of these combinations showed immense promise. Given their market potential, most pharma/biotech bigwigs are scurrying to grab a larger chunk of this pie.

Merck’s MRK immuno-oncology drug Keytruda in combination with Inlyta is also approved for the first-line treatment of patients with advanced RCC.

Meanwhile, Exelixis is currently evaluating cabozantinib for additional indications as well. Revenues generated from the drug's approved indications are expected to support its pipeline progress.

Exelixis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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