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Exelixis Says US FDA Will Review Supplemental NDA for Prospective Treatment for Pancreatic Tumors in March
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Exelixis Says US FDA Will Review Supplemental NDA for Prospective Treatment for Pancreatic Tumors in March
Nov 26, 2024 2:53 PM

05:37 PM EST, 11/26/2024 (MT Newswires) -- Exelixis ( EXEL ) said late Tuesday that the US Food and Drug Administration's Oncologic Drugs Advisory Committee will review the supplemental new drug application for the company's cabozantinib drug candidate in March.

The advisory committee will review data from a phase 3 trial that showed substantial improvement in progression-free survival in patients with advanced pancreatic or extra-pancreatic neuroendocrine tumors who were treated with cabozantinib, the company said.

In August, Exelixis ( EXEL ) said the FDA designated cabozantinib as an orphan drug and set an April 3 deadline on whether to approve the prospective treatment for pancreatic cancer.

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