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These highlights do not include all the information needed to use AVMAPKI™ FAKZYNJA™ CO-PACK safely and effectively. See full prescribing information for AVMAPKI™ FAKZYNJA™ CO-PACK. AVMAPKI™ FAKZYNJA™ CO-PACK (avutometinib capsules; defactinib tablets), co-packaged for oral use Initial U.S. Approval: 2025
Medication labelWhy this: Advisory · dailymed-prescription
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 [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- generic_name
- avutometinib potassium and defactinib hydrochloride
- brand_name
- avutometinib potassium, defactinib hydrochloride
- product_names
- avutometinib potassium and defactinib hydrochloride, avutometinib potassium, defactinib hydrochloride
- ndc
- 71779-623, 71779-623-01, 71779-660, 71779-660-02, 71779-630, 71779-630-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en