Brand Name
Avmapki Fakzynja Co-Pack
Generic Name
Defactinib
View Brand Information FDA approval date: May 01, 2025
Form: Kit
What is Avmapki Fakzynja Co-Pack (Defactinib)?
AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer 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. 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 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.
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Brand Information
AVMAPKI FAKZYNJA CO-PACK (avutometinib potassium and defactinib hydrochloride)
1INDICATIONS AND USAGE
AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with
This indication is approved under accelerated approval based on tumor response rate and duration of response
2DOSAGE FORMS AND STRENGTHS
AVMAPKI FAKZYNJA CO-PACK is AVMAPKI (avutometinib) capsules co-packaged with FAKZYNJA (defactinib) tablets.
- AVMAPKI capsules contain 0.8 mg avutometinib and are white capsules with "6766" printed on the cap and the strength "0.8 mg" printed on the body in black ink.
- FAKZYNJA tablets contain 200 mg defactinib and are white to off-white tablets, oval and debossed with "VS2" on one side.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following adverse reactions are discussed in more detail in other sections of the labeling:
- Ocular Toxicities
- Serious Skin Toxicities
- Hepatotoxicity
- Rhabdomyolysis
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The pooled safety population described in Warnings and Precautions reflect exposure to the AVMAPKI FAKZYNJA CO-PACK (combination of AVMAPKI 3.2 mg twice weekly and FAKZYNJA 200 mg twice daily) for the first 3 weeks in a 4-week cycle until disease progression or unacceptable toxicity in 136 adult patients with recurrent LGSOC treated on RAMP-201 and FRAME (NCT03875820). The median duration of treatment was 10 months (range 0 to 51 months).
5DESCRIPTION
AVMAPKI FAKZYNJA CO-PACK contains AVMAPKI (avutometinib) capsules co-packaged with FAKZYNJA (defactinib) tablets.
AVMAPKI capsules contain avutometinib, a kinase inhibitor. The chemical name of avutometinib is N-(3-Fluoro-4-{[4-methyl-7-(2-pyrimidinyloxy)-2H-chromen-2-on-3-yl]methyl}-2-pyridyl)-N'-methylsulfamide potassium salt. The molecular formula for avutometinib is C
Avutometinib potassium is a white to pale yellow powder. It is practically insoluble in the pH range of 1 to 7 in aqueous media. The pKa is 7.02.
AVMAPKI capsules for oral administration contain 0.8 mg of avutometinib (equivalent to 0.864 mg as the avutometinib potassium salt) with the following inactive ingredients: magnesium stearate and mannitol in a hypromellose capsule shell (carrageenan, hypromellose, potassium chloride, purified water, and titanium oxide) printed with black ink (black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution).
FAKZYNJA tablets contain defactinib, a kinase inhibitor. The chemical name of defactinib is N-methyl-4-({4-[({3-methyl(methylsulfonyl)aminopyrazin-2-yl}methyl)amino]-5-(trifluoromethyl)pyrimidin-2-yl}amino)benzamide hydrochloride. The molecular formula for defactinib is C
Defactinib hydrochloride is a white to pale yellow powder. It is very slightly soluble at pH 1 and practically insoluble in the pH range of 4.5 to 6.8 in aqueous media. The pKa is 3.81.
FAKZYNJA tablets are available for oral administration. Each FAKZYNJA tablet contains 200 mg defactinib (equivalent to 214.36 mg as the defactinib hydrochloride salt) and the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.
6CLINICAL STUDIES
The efficacy of AVMAPKI FAKZYNJA CO-PACK was evaluated in RAMP-201 (NCT04625270), an open-label, multicenter study that included 57 adult patients with measurable
Patients received AVMAPKI 3.2 mg orally twice weekly for the first 3 weeks out of a 4-week cycle and FAKZYNJA 200 mg orally twice daily for the first 3 weeks out of a 4-week cycle until disease progression or unacceptable toxicity. The major efficacy outcome measure was overall response rate (ORR) assessed by blinded independent review committee (BIRC) according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. An additional efficacy outcome measure was duration of response (DoR). Tumor response assessments occurred every 8 weeks for the first 72 weeks and every 12 weeks thereafter.
The median age was 60 years (range: 29 to 87); 75% were White, 3.5% were Asian, 3.5% were Black or African American, and 18% did not have race reported; 3.5% of patients were Hispanic or Latino; 72% had an ECOG PS of 0 and 28% had ECOG PS of 1. The
Efficacy results are presented in Table 5.
The tumor
7HOW SUPPLIED/STORAGE AND HANDLING
AVMAPKI FAKZYNJA CO-PACK is supplied in a carton that contains:
- AVMAPKI (avutometinib) 0.8 mg capsules are supplied as white capsules with "6766" printed on the cap and the strength "0.8 mg" printed on the body in black ink in a bottle containing 24 capsules. The bottle contains a desiccant that should not be discarded.
- FAKZYNJA (defactinib) 200 mg tablets are supplied as white to off-white, oval and debossed with "VS2" on one side of the tablet in a bottle containing 42 tablets.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
9PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 71779-623-01
AVMAPKI™
FAKZYNJA™
CO-PACK
This carton contains:
AVMAPKI™ (avutometinib):
FAKZYNJA™ (defactinib):
Prescribing Information
Patient Dosing Card
KEEP REFRIGERATED
VERASTEM™
10PRINCIPAL DISPLAY PANEL - 0.8 mg Capsule Bottle Label
NDC 71779-660-02
AVMAPKI™
KEEP
24 capsules
773622
Recommended Dosage:
Manufactured for:
For information, call toll-free
VERASTEM™
© 2025 Verastem, Inc.
11PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label
NDC 71779-630-01
FAKZYNJA™
KEEP REFRIGERATED
42 tablets
VERASTEM™
Recommended Dosage: See
Manufactured for:
For information, call toll-free
© 2025 Verastem, Inc.
773624
