(RTTNews) - Exelixis Inc. (EXEL), an oncology company, has announced a key update regarding its label expansion of CABOMETYX for the treatment of advanced neuroendocrine tumors.
The company has been notified by the FDA that the supplemental New Drug Application for CABOMETYX, intended for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic neuroendocrine tumors (epNET), will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025.
The final FDA decision on the label expansion of CABOMETYX is expected to be announced on April 3, 2025.
The sNDA submission is based on the positive results of the CABINET phase 3 clinical trial, which evaluated the effectiveness of CABOMETYX compared to a placebo in patients with advanced pNET and epNET.
The final results from the trial showed significant improvements in progression-free survival (PFS) for patients treated with CABOMETYX. These results were presented at the 2024 European Society for Medical Oncology Congress and published in the New England Journal of Medicine.
Additionally, in August 2024, the FDA granted orphan drug designation to CABOMETYX for treating pNET, a designation for drugs targeting rare diseases that offer benefits like market exclusivity.
CABOMETYX is already approved by the FDA for the treatment of advanced renal cell carcinoma, hepatocellular carcinoma, and differentiated thyroid cancer. The drug generated annual net product revenues of $1,614.9 million in the U.S. in 2023.
EXEL closed Tuesday's trading at $36.45, up 0.19%.
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