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avmapki fakzynja co-pack

Generic: avutometinib; defactinib

avmapki fakzynja co-pack: sourced relationships with 1 company · 1 FDA decision.

avmapki fakzynja co-pack evidence translation

What we can confirm

What it means

Source-backed records connect avmapki fakzynja co-pack to VSTM; that link alone does not prove the drug works.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

How could avmapki fakzynja co-pack → VSTM affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC)

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
Verastem, Inc. (VSTM)
developer · Reported 2026-03-04 · Current development: unknownSource
KRAS-mutated recurrent low-grade serous ovarian cancer (LGSO…
Approved
FDA Decisions1 records
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 CO-PACK, a combination of avutometinib and defactinib, each kinase inhibitors, 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. ( 1 , 14 )(VSTM)FDA ↗
NDA219616Type 1 - New Molecular EntityOrphan DrugPriorityOralCapsule, Tablet

Frequently asked questions

Which companies have sourced relationships with avmapki fakzynja co-pack?

avmapki fakzynja co-pack has dated SEC/FDA relationship records for 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 CO-PACK, a combination of avutometinib and defactinib, each kinase inhibitors, 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. ( 1 , 14 ), dated May 8, 2025.