Avmapki Fakzynja Co-Pack FDA Approval History
Last updated by Judith Stewart, BPharm on May 19, 2025.
FDA Approved: Yes (First approved May 8, 2025)
Brand name: Avmapki Fakzynja Co-Pack
Generic name: avutometinib and defactinib, co-packaged
Dosage form: Capsules/Tablets
Company: Verastem Oncology
Treatment for: Ovarian Cancer
Avmapki Fakzynja Co-Pack (avutometinib and defactinib, co-packaged) is a kinase inhibitor combination for the treatment of KRAS-mutated recurrent low-grade serous ovarian cancer.
- Avmapki Fakzynja Co-Pack is indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.
- This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. - LGSOC is a rare ovarian cancer that is highly recurrent and less sensitive to chemotherapy compared to high-grade serous ovarian cancer (HGSOC). Approximately 30 percent of people with LGSOC have a KRAS mutation.
- Avmapki (avutometinib) works in the treatment of LGSOC by inhibiting MEK kinase activity while also blocking the compensatory reactivation of MEK by upstream RAF. RAF and MEK proteins are regulators of the RAS/RAF/MEK/ERK (MAPK) pathway, and blocking RAF and/or MEK activates FAK (Focal Adhesion Kinase), a key mediator of drug resistance. Fakzynja works by inhibiting FAK, and together, the combination provides a more complete blockade of the signaling that drives the growth and drug resistance of RAS/MAPK pathway-dependent tumors.
- FDA approval of the Avmapki Fakzynja Co-Pack was based on the Phase 2 RAMP 201 study (NCT04625270) that demonstrated an overall response rate of 44% and a median duration of response ranging from 3.3 to 31.1 months in patients with KRAS mutant recurrent LGSOC.
- The Avmapki Fakzynja Co-Pack contains Avmapki capsules and Fakzynja tablets. The Avmapki capsules are administered orally twice weekly (Day 1 and Day 4) for the first 3 weeks of each 4-week cycle, and the Fakzynja tablets are administered orally twice daily for the first 3 weeks of each 4-week cycle.
- Warnings and precautions associated with the Avmapki Fakzynja Co-Pack include ocular toxicities (including visual impairment and vitreoretinal disorders), serious skin toxicities (including photosensitivity and severe cutaneous adverse reactions), hepatotoxicity, rhabdomyolysis, and embryo-fetal toxicity.
- Common (≥ 25%) adverse reactions include nausea, fatigue, rash, diarrhea, musculoskeletal pain, edema, vomiting, abdominal pain, dyspepsia, dermatitis acneiform, vitreoretinal disorders, stomatitis, pruritus, visual impairment, constipation, dry skin, dyspnea, cough, and urinary tract infection.
Common laboratory abnormalities include increased creatine phosphokinase, increased aspartate aminotransferase, decreased hemoglobin, increased alanine aminotransferase, increased blood bilirubin, increased triglycerides, decreased lymphocyte count, increased alkaline phosphatase, decreased platelet count, and decreased neutrophil count.
Development timeline for Avmapki Fakzynja Co-Pack
Further information
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