By Josh Beckerman
Verastem Oncology said the Food and Drug Administration approved the combination of avutometinib capsules and defactinib tablets for certain patients with KRAS-mutated recurrent low-grade serous ovarian cancer.
The company expects a combination co-pack will be available in the U.S. in about a week.
The approval was in advance of the June 30 Prescription Drug User Fee Act action date.
Verastem shares were flat at $6.69 prior to a trading halt for pending news.
Write to Josh Beckerman at josh.beckerman@wsj.com
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By Josh Beckerman
Verastem Oncology said the Food and Drug Administration approved the combination of Avmapki capsules and Fakzynja tablets for certain ovarian-cancer patients.
The company said Thursday it expects the combination co-pack of Avmapki and Fakzynja--or avutometinib and defactinib, respectively--will be available in the U.S. in about a week, marking its transition into a commercial-stage company.
Verastem previously said it was preparing for a mid-2025 launch. The FDA's approval was in advance of the June 30 Prescription Drug User Fee Act action date.
The Needham, Mass., company's shares, flat at $6.69 prior to a trading halt for pending news, spiked to $8 but were recently up 3.5%, to $6.93. The stock is up about 34% this year.
Accelerated approval was based on the Phase 2 RAMP 201 study that demonstrated a 44% overall response rate in patients with KRAS-mutated recurrent low-grade serous ovarian cancer, the company said. Verastem said it is conducting a confirmatory Phase 3 trial, RAMP 301.
Write to Josh Beckerman at josh.beckerman@wsj.com
(END) Dow Jones Newswires
May 08, 2025 14:59 ET (18:59 GMT)
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