Exelixis (EXEL) Gets FDA Nod for Cabometyx for Thyroid Cancer

Exelixis, Inc.  EXEL has announced that the FDA approved Cabometyx (cabozantinib) for another indication.

The drug is now approved in the United States for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor (VEGFR)-targeted therapy. The patients are also radioactive iodine-refractory or ineligible.

The approval comes more than two months ahead of the target action date of Dec 4, 2021.

The FDA approval was based on positive results from the phase III study, COSMIC-311, which demonstrated significant improvement in progression-free survival with Cabometyx versus placebo.

We remind investors that the drug is already approved in the United States for the treatment of patients with advanced renal cell carcinoma (RCC) for the treatment of patients with hepatocellular carcinoma who have been previously treated with Bayer’s BAYRY Nexavar. It is also approved for patients with advanced RCC as a first-line treatment in combination with Bristol Myers’ BMY Opdivo.

Label expansion of the drug for additional indications will boost sales of the drug. Per the company, DTC is the most common type of thyroid cancer in the United States and patients who are resistant to radioactive iodine treatment face a poor prognosis. Per estimates, roughly 44,000 new cases of thyroid cancer will be diagnosed in the United States in 2021.

Exelixis’ shares have gained 3.2% in the year so far against the industry’s growth of 0.9%.


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The approval of Cabometyx in combination with immuno-oncology drug, Opdivo, for advanced RCC has boosted sales significantly.

It is also being evaluated for other indications.  In May, Exelixis announced results from the metastatic castration-resistant prostate cancer (CRPC) cohort 6 of COSMIC-021, the phase Ib study of cabozantinib in combination with Roche’s RHHBY Tecentriq in patients with locally advanced or metastatic solid tumors.

It recently announced detailed results from the expanded cohort 6 of the COSMIC-021 study at the 2021 European Society of Medical Oncology (ESMO) Congress (LBA24). Cohort 6 included patients with metastatic CRPC who had been previously treated with the novel hormone therapies (NHT) enzalutamide and/or abiraterone acetate used along with prednisone. However, following discussions with the FDA, Exelixis will not pursue a regulatory submission for the combination regimen based on cohort 6 of the COSMIC-021 trial. The CONTACT-02 study, a global phase III pivotal trial, initiated enrollment in June 2020 and is evaluating cabozantinib in combination with Tecentriq versus a second NHT in patients with metastatic CRPC who have been previously treated with one NHT. Pending results, CONTACT-02 may serve as a basis for future regulatory applications in this setting.

Exelixis is also looking to build a differentiated next-generation pipeline in oncology through strategic collaborations. The successful development of additional candidates will diversify its revenue base and reduce dependence on Cabometyx.

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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