Treats KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC). NDA 219616, held by Verastem Inc. Avutometinib Potassium; Defactinib Hydrochloride.
As of Nov 13, 2026, NDA 219616 (Avmapki Fakzynja Co-Pack (Copackaged)), held by Verastem Inc, was first approved by FDA on May 8, 2025, with 0 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 8, 2025 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Avmapki Fakzynja Co-Pack (Copackaged)EQ 0.8MG BASE;EQ 200MG BASE · capsule, tablet;oral | Avutometinib Potassium; Defactinib Hydrochloride | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
