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Following news that the U.S. Food and Drug Administration approved its New Drug Application for avutometinib in combination with defactinib to treat recurrent low-grade serous ovarian cancer in patients with KRAS mutations, Verastem Inc. (VSTM, Financials) jumped 24.8% to $4.58. Setting a Prescription Drug User Fee Act action deadline of June 30, 2025, the FDA granted Priority Review, Verastem stated in a statement.
Should approval be granted, the treatmentwhich is the first FDA-approved one expressly aimed at adults with recurrent KRAS mutant LGSOCwould Based on information from the Phase 2 RAMP 201 study, which showed notable response rates and tolerability for the combination treatment, the firm said, the application expands on data.
With few therapeutic choices, LGSOC is an uncommon kind of ovarian cancer afflicting between 6,0008,000 women in the United States. Verastem underlined the ability of the treatment to solve this unmet medical need.
Verastem's president and CEO, Dan Paterson, hailed the FDA's approval as a major step toward giving patients a much needed medication. Depending on regulatory permission, the business is getting ready for a commercial release by mid-2025.
Emphasizing its therapeutic potential, the FDA has additionally given Breakthrough Therapy and Orphan Drug Designations to the combo treatment. To assess more general uses of the treatment, Verastem is doing several studies including the Phase 3 RAMP 301 research.
Verastem has teamed with Amgen (AMGN, Financials) to investigate in non-small cell lung cancer and other indications the combination of avutometinib, defactinib, and Amgen's KRAS inhibitor Lumakras. Initial results for this triplet treatment seem encouraging.
Verastem's pipeline's emphasis is on RAS/MAPK-driven tumors, so the FDA's ruling might have a major influence on their treatment. It also emphasizes the rising importance of targeted treatments in changing oncology therapy.
This article first appeared on GuruFocus.