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Thursday, May 8, 2025

FDA Approves Verastem Combo for Ovarian Cancer

 AVMAPKI plus FAKZYNJA to be commercially available by prescription as a convenient oral combination co-packaged together and will be known as “AVMAPKI FAKZYNJA CO-PACK”

Accelerated approval, well ahead of the June 30, 2025 PDUFA action date, was based on the Phase 2 RAMP 201 study that demonstrated a 44% overall response rate in patients with KRAS mutant recurrent LGSOC

Verastem to host investor conference call and webcast today at 2:30 pm ET

Verastem will hold an investor conference call and webcast today at 2:30 pm ET, to discuss the FDA approval of AVMAPKI FAKZYNJA CO-PACK. To access the conference call, please dial (844) 763-8274 (local) or (412) 717-9224 (international) at least 10 minutes prior to the start time and ask to be joined into the Verastem Oncology conference call. A live audio webcast of the call, along with accompanying slides, will be accessible under “Events & Presentations” in the Investors & Media section of the Company’s website at www.verastem.com.

https://www.businesswire.com/news/home/20250508131607/en/FDA-Approves-the-AVMAPKI-FAKZYNJA-Combination-Therapy-as-the-First-Ever-Treatment-for-Adult-Patients-with-KRAS-mutated-Recurrent-Low-Grade-Serous-Ovarian-Cancer

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