Exelixis Provides Regulatory Update Related to Supplemental New Drug Application for Cabozantinib (CABOMETYX®) for the Treatment of Patients with Previously Treated Advanced Neuroendocrine...
Exelixis, Inc. (EXEL)
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Source: Business Wire
ALAMEDA, Calif.--(BUSINESS WIRE)--Exelixis, Inc. (Nasdaq: EXEL) today announced that the U.S. Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (CABOMETYX®) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. The sNDA is based on the final results of the phase 3 CABINET pivotal trial, conducted by the National Cancer Institute's National Clinical Trials Network, evaluating cabozantinib compared with placebo in advanced pNET and advanced epNET. In August 2024, Exelixis announced that the FDA granted orphan drug designation to cabozantinib for the treatment of pNET and assigned a Prescription Drug User Fee Act target action date of April 3, 2025.As announced in August 2023, the Alliance for Clinical Trials in Oncology independent
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EXEL
Earnings
- 10/29/24 - Beat
EXEL
Sec Filings
- 12/23/24 - Form 4
- 12/2/24 - Form 4
- 11/29/24 - Form 144
- EXEL's page on the SEC website