FDA record · Cancer
Avmapki Fakzynja Co-pack (copackaged) (avutometinib potassium; defactinib hydrochloride)
What FDA's own documents say about Avmapki Fakzynja Co-pack (copackaged): what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.
- Sponsor
- Verastem Inc.
- Application
- NDA 219616
- First approved
- May 8, 2025
- Status
- Accelerated approval
- Read from
- 11 FDA documents, 756 pages
What it is approved for
“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.”
Prescribing Information (Label) · PDF p. 2 · fda.gov ↗
Trials FDA reviewed
| Trial | ClinicalTrials.gov | Phase | Mentions | Documents |
|---|---|---|---|---|
| RAMP-201 | NCT03875820 | 354 | 6 of 11 | |
| RAMP-301VS-6766-301 | NCT06072781 | 3 | 38 | 5 of 11 |
| Study RAMP | not given | 11 | 4 of 11 | |
| RAMP 202VS-6766-202 | NCT04620330 | 2 | 10 | 1 of 11 |
| GOG-281 | not given | 8 | 2 of 11 | |
| VSM-003 | not given | 5 | 1 of 11 |
Mentions: how many sentences across the FDA documents name the trial. NCT ids are read from the documents or, where they give none, matched on ClinicalTrials.gov by the trial's name or protocol code.
Safety
Adverse events the documents discuss most
- left ventricular dysfunction 55 mentions
- hepatotoxicity 43 mentions
- death 24 mentions
- QTc prolongation 12 mentions
- hypersensitivity 8 mentions
- anemia 6 mentions
- neutropenia 5 mentions
- febrile neutropenia 3 mentions
Dosing on the label
“The recommended dosage of AVMAPKI capsules is 3.2 mg (four 0.8 mg capsules) taken orally twice weekly (Day 1 and Day 4) for the first 3 weeks of each 4-week cycle until disease progression or unacceptable toxicity.”
Prescribing Information (Label) · PDF p. 3 · fda.gov ↗
“The recommended dosage of FAKZYNJA tablets is 200 mg (one tablet) taken orally twice daily for the first 3 weeks of each 4-week cycle until disease progression or unacceptable toxicity.”
Prescribing Information (Label) · PDF p. 4 · fda.gov ↗
FDA documents read
| Document | Date | Pages | Copy | sha256 |
|---|---|---|---|---|
| Prescribing information, original approval219616s000lbl.pdf | May 8, 2025 | 27 | 580f15f85088 | |
| Approval letter219616Orig1s000ltr.pdf | May 15, 2025 | 13 | 234202802b69 | |
| Administrative Correspondence219616Orig1s000AdminCorres.pdf | June 20, 2025 | 73 | a3ad71cd2e9d | |
| Approval Letter219616Orig1s000Approv.pdf | June 20, 2025 | 16 | 43c1d412496d | |
| Chemistry Review219616Orig1s000ChemR.pdf | June 20, 2025 | 38 | a8098797784b | |
| Prescribing Information (Label)219616Orig1s000Lbl.pdf | June 20, 2025 | 34 | df2534ff195f | |
| Multi-disciplinary Review219616Orig1s000MultidisciplineR.pdf | June 20, 2025 | 371 | 234d3270453b | |
| Proprietary Name Review219616Orig1s000NameR.pdf | June 20, 2025 | 50 | 7e160db5b0f2 | |
| Officer/Employee List219616Orig1s000OEList.pdf | June 20, 2025 | 2 | c69b158ee0b9 | |
| Other Reviews219616Orig1s000OtherR.pdf | June 20, 2025 | 115 | 7c97770402f2 | |
| Risk Assessment / REMS Review219616Orig1s000RiskR.pdf | June 20, 2025 | 17 | b7ebe376312e |
Checked against FDA's copies on September 30, 2026. The sha256 is the fingerprint of the file that was read: download it from fda.gov and compare. Quotes come from the text of each file as read; pages FDA stored as images were read by OCR and are marked.
Generated automatically (auto): the trials, names and dates are drafted from the documents by rules, with no language model; see the method.
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