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  1. verastem.com
    https://investor.verastem.com › news-releases › news-release-details › ...

    FDA Approves the AVMAPKI™ FAKZYNJA™ Combination Therapy …

    May 8, 2025 · BOSTON -- (BUSINESS WIRE)--May 8, 2025-- Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients …

  2. fiercepharma.com
    https://www.fiercepharma.com › pharma › verastem-scores-fda-nod-oral...

    FDA approves Verastem's combo for rare form of ovarian cancer

    May 9, 2025 · Verastem is running a confirmatory phase 3 trial, RAMP 301, pitting the combo against standard chemotherapy or hormonal therapy for the treatment of recurrent LGSOC …

  3. reuters.com
    https://www.reuters.com › business › healthcare...

    US FDA approves Verastem's ovarian cancer therapy | Reuters

    May 8 (Reuters) - The U.S. Food and Drug Administration has approved Verastem's (VSTM.O) combination therapy for patients with a rare type of ovarian cancer who have received prior …

  4. mskcc.org
    https://www.mskcc.org › news › fda-approves-avutometinib-defactinib...

    FDA Approves Avutometinib-Defactinib Combination for Treating …

    May 12, 2025 · The first drug for a rare and difficult-to-treat type of ovarian cancer has been granted accelerated approval by the Food and Drug Administration (FDA). The treatment, …

  5. nature.com
    https://www.nature.com › articles

    FDA approves a rare novel–novel oncology combination that …

    May 13, 2025 · The FDA has granted accelerated approval to Verastem’s FAK inhibitor defactinib (Fakzynja) in combination with its MEK inhibitor avutometinib (Avmapki) for KRAS-mutated …

  6. webmd.com
    https://www.webmd.com › ovarian-cancer › news › fda-approves...

    FDA Approves New Oral Drug Combo for Rare Ovarian Cancer

    May 9, 2025 -- A new oral cancer drug combination has gained a quick federal nod after clinical trials found that it provides significant and longer-lasting relief for a rare ovarian cancer...

  7. oncologynewscentral.com
    https://www.oncologynewscentral.com › drug › fda-approves-first-ever...

    FDA Approves First-Ever Drug Combo for Low-Grade Serous Ovarian Cancer

    May 9, 2025 · The U.S. Food and Drug Administration (FDA) granted accelerated approval to avutometinib plus defactinib (Avmapki Fakzynja Co-pack) for adults with KRAS-mutated …

  8. medscape.com
    www.medscape.com › Medscape Medical News › FDA Approvals

    FDA Approves Novel Treatment for KRAS-Mutated Ovarian Cancer …

    May 8, 2025 · The US Food and Drug Administration (FDA) has granted accelerated approval of combination avutometinib and defactinib (Avmapki Fakzynja Co-pack, Verastem, Inc.) for the …

  9. pmlive.com
    https://pmlive.com › pharma_news › fda-approves-verastem-oncologys...

    FDA approves Verastem Oncology’s combination therapy for …

    May 12, 2025 · Avmapki Fakzynja co-pack (avutometinib capsules; defactinib tablets) has been authorised to treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) in …

  10. pharmexec.com
    https://www.pharmexec.com › view › fda-grants-accelerated-approval...

    FDA Grants Accelerated Approval to Verastem Oncology’s …

    May 9, 2025 · The FDA has granted accelerated approval to Verastem Oncology’s Avmapki Fakzynja Co-Pack (avutometinib capsules and defactinib tablets). The regulatory action marks …

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