Exelixis, Inc . EXEL announced that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines to include new recommendations for lead drug Cabometyx.
As a result of the update, Cabometyx is now recommended by the NCCN for the treatment of advanced renal cell carcinoma (RCC), regardless of patient risk status (favorable-, intermediate- and poor-risk).
Per the updated guidelines, Cabometyx is the only preferred tyrosine kinase inhibitor (TKI) treatment option for first-line patients in the poor- and intermediate-risk groups (Category 2A). It is also recommended as a first-line treatment option for favorable-risk patients (Category 2B). The guidelines further state that Cabometyx is the only preferred TKI treatment option for previously treated patients (Category 1).
We note that the NCCN kidney cancer panel's decision to include Cabometyx as a Category 2A preferred option for the treatment of patients with previously untreated advanced RCC with poor- or intermediate-risk disease was based on the results of the phase II trial, CABOSUN.
Moreover, the NCCN also added cabozantinib as a Category 1 option for the treatment of patients with hepatocellular carcinoma (HCC) (Child-Pugh Class A only), who have been previously treated with Nexavar, in its recent update to the Clinical Practice Guidelines for Hepatobiliary Cancers.
However, the drug is not yet approved for this indication. In May 2018, the FDA accepted the supplemental New Drug Application for Cabometyx in previously treated advanced HCC and assigned it a Prescription Drug User Fee Act (PDUFA) action date of Jan 14, 2019.
Exelixis' shares have lost 39.0% in the year so far compared with the industry's decline of 5.1%.
Meanwhile, demand for Cabometyx grew by approximately 16% sequentially in the first quarter. The company experienced a 14% increase in Cabometyx's prescriber base in the second quarter as compared to the first quarter. Cabometyx sales are expected to rise further in 2018 as the drug is now approved for first-line RCC, which will expand the eligible patient population in the United States and also eat into the market share of two key drugs , Pfizer's PFE Sutent and Novartis' NVS Votrient. A potential approval for HCC early next year should further boost the drug's demand.
However, competition further stiffened with the approval of Bristol Myers' BMY Opdivo and Yervoy for the treatment of poor and intermediate risk first-line RCC.
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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