The U.S. FDA Accepts Exelixis sNDA of CABOMETYX® for Priority Review

Exelixis sNDA Accepted by the US FDA for CABOMETYX®

The U.S. Food and Drug Administration (FDA) accepted Exelixis (EXEL) supplemental New Drug Application (sNDA) for CABOMETYX ® (cabozantinib) as a treatment for patients 12 years and older with differentiated thyroid cancer (DTC) who have progressed following prior therapy and are radioactive iodine-refractory (if radioactive iodine is appropriate).

The FDA granted Priority Review designation and assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 4, 2021.

From the President & CEO of Exelixis

Michael M. Morrissey, Ph.D., President, and Chief Executive Officer, Exelixis, said, “The FDA’s acceptance of our sNDA with Priority Review is an important step toward our goal of bringing CABOMETYX to patients with previously treated radioactive iodine-refractory differentiated thyroid cancer. Considering the lack of a standard of care in the treatment of this cancer following anti-VEGFR therapy, the progression-free survival benefit demonstrated in phase 3 COSMIC-311 pivotal trial means CABOMETYX, if approved, could become an important new treatment for these patients.”

COSMIC-311 Phase 3 Pivotal Trial

The sNDA is based on results of COSMIC-311 phase 3 pivotal trial evaluating CABOMETYX versus placebo in patients with radioactive iodine- refractory DTC who progressed after up to two prior vascular endothelial growth factor receptor (VEGFR)-targeted therapies. CABOMETYX met one of the trial’s primary endpoints, demonstrating a significant improvement in progression-free survival versus placebo.

In February 2021, the FDA granted Breakthrough Therapy Designation to CABOMETYX as a potential treatment for patients with DTC, which has progressed following prior therapy and who are radioactive iodine-refractory.

Detailed findings were presented at the 2021 American Society of Clinical Oncology Annual Meeting and were published by The Lancet Oncology in July 2021.

Differentiated Thyroid Cancer

Approximately 44,000 new cases of thyroid cancer will be diagnosed in the U.S. in 2021.

Nearly three out of four of these cases will be in women, and the disease is more commonly diagnosed at a younger age compared to most other adult cancers.

Differentiated thyroid cancer is typically treated with surgery followed by ablation of the remaining thyroid tissue with radioiodine.  

Differentiated thyroid tumors make up about 90 percent of cases. Approximately 5% to 15% of cases are resistant to radioiodine treatment.


In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced renal ce3ll carcinoma (RCC), patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib; and for patients with advanced RCC as a first-line treatment in combination with nivolumab. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States.

CABOMETYX is not indicated for radioactive iodine-refractory differentiated thyroid cancer.

CABOMETYX® Drug Interactions

  • Strong CYP3A4 Inhibitors: In case the coadministration cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.
  • Strong CYP3A4 Inducers: In case the coadministration cannot be avoided, increase the CABOMETYX dosage. Avoid St. John’s wort.

For safety information please read the full prescribing information.

Prohost Observations

This news adds more good news to Exelixis regarding revenues, incomes and growth potential. Will this and the expected upcoming good news boost the firm’s stocks prices, which are being suppressed by negative investors and establishments? Anyway, the time will come when the reality cannot be hidden from investors’ by the short, regardless of how big, or small, short investors can be. 

For now, we wait.

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