Verastem Oncology's Ovarian Cancer Drug Gets FDA Orphan Drug Designation
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Dow Jones
By Sabela Ojea
Verastem Oncology said its avutometinib drug has been granted an orphan drug designation from the Food and Drug Administration.
The biopharmaceutical company said the FDA granted the orphan drug designation for avutometinib alone or in combination with defactinib in low-grade serous ovarian cancer.
"We remain on track to begin submission of an NDA to the FDA for accelerated approval of this combination in the first half of 2024 and [are] preparing for a potential launch in 2025," Chief Executive Dan Paterson said.
Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix
(END) Dow Jones Newswires
March 05, 2024 17:58 ET (22:58 GMT)
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