avmapki fakzynja co-pack

Generic: avutometinib; defactinib

avmapki fakzynja co-pack: developed by 1 company · 1 FDA decision. Updated within the last hour.

Development Pipeline (1)

CompanyPhase
Verastem, Inc. (VSTM)Approved

FDA Decisions

Approval1 INDICATIONS AND USAGE 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. AVMAPKI FAKZYNJA(VSTM)

Frequently asked questions

Who is developing avmapki fakzynja co-pack?

avmapki fakzynja co-pack is being developed by Verastem, Inc..

What is avmapki fakzynja co-pack's latest FDA decision?

The most recent tracked FDA decision for avmapki fakzynja co-pack is Approval for 1 INDICATIONS AND USAGE 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. AVMAPKI FAKZYNJA, dated May 8, 2025.

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