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Avmapki

avutometinib
RAF/MEK InhibitorFDA Approved 2025Verastem Oncology
Route
Oral
Half-Life
~8 hrs
FDA Approved
2025
Manufacturer
Verastem Oncology
1. Indications and Usage

In combination with defactinib (Fakzynja) for adults with KRAS-mutated previously treated low-grade serous ovarian cancer.

2. Dosage and Administration

3.2 mg orally once daily on Days 1-21 of each 28-day cycle, in combination with defactinib. Continue until disease progression or unacceptable toxicity.

3. Dosage Forms and Strengths

Tablets: 3.2 mg

4. Contraindications

None listed in the prescribing information.

5. Warnings and Precautions
  • Retinal Pigment Epithelial Detachment: Ophthalmologic exams prior to and during treatment.
  • Cardiomyopathy: Assess LVEF at baseline and periodically.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Diarrhea (56%), Nausea (48%), Fatigue (42%), Rash (38%), Vomiting (32%), Edema (28%), Increased Creatinine (22%), CPK Elevation (18%)

Diarrhea
56%
Nausea
48%
Fatigue
42%
Rash
38%
Vomiting
32%
Edema
28%
Increased Creatinine
22%
CPK Elevation
18%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Strong CYP3A4 Inhibitors: Avoid.
Strong CYP3A4 Inducers: Avoid.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Avutometinib is a RAF/MEK clamp inhibiting both RAF and MEK in the RAS-MAPK pathway. Combined with defactinib (FAK inhibitor), it provides dual pathway blockade in KRAS-mutant tumors.

Pharmacokinetics

Tmax: 1-2 hours. Protein binding: ~99%. Metabolized by CYP3A4. Half-life: ~5.5 hours.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Avutometinib Trials on ClinicalTrials.gov ↗ 📚 PubMed: Avutometinib Clinical Trials ↗
FDA-Approved Tumor Types

Avmapki has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Ovarian Cancer
External Resources
📋 DailyMed Label ↗🏛️ FDA Drugs@FDA ↗🔬 ClinicalTrials.gov ↗📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Avmapki. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Avmapki (avutometinib) approved for?

Avmapki (avutometinib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Avmapki (avutometinib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Avmapki (avutometinib) work?

Avutometinib is a RAF/MEK clamp inhibiting both RAF and MEK in the RAS-MAPK pathway. Combined with defactinib (FAK inhibitor), it provides dual pathway blockade in KRAS-mutant tumors.

What are the most common side effects?

Diarrhea (56%), Nausea (48%), Fatigue (42%), Rash (38%), Vomiting (32%), Edema (28%), Increased Creatinine (22%), CPK Elevation (18%) Diarrhea 56% Nausea 48% Fatigue 42% Rash 38% Vomiting 32% Edema 28% Increased Creatinine 22% CPK Elevation 18%

← All TherapiesFull Prescribing Information ↗