In combination with avutometinib (Avmapki) for adults with KRAS-mutated previously treated low-grade serous ovarian cancer.
200 mg orally twice daily in combination with avutometinib on Days 1-21 of each 28-day cycle.
Tablets: 200 mg
None listed in the prescribing information.
Diarrhea (56%), Nausea (48%), Fatigue (42%), Rash (38%), Vomiting (32%), Edema (28%), Increased Creatinine (22%)
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
Strong CYP3A4 Inhibitors: Avoid.
Strong CYP3A4 Inducers: Avoid.
Consult the full prescribing information for pregnancy-related considerations.
Refer to prescribing information for lactation guidance.
Pediatric safety and efficacy information is detailed in the full label.
Dose modifications for organ impairment are specified in the complete prescribing information.
Defactinib is a selective oral inhibitor of focal adhesion kinase (FAK), disrupting compensatory signaling that tumors use to escape MAPK pathway blockade, synergizing with avutometinib.
Tmax: 1-2 hours. Protein binding: ~93%. Metabolized by CYP3A4. Half-life: ~4 hours.
Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.
Fakzynja has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:
Fakzynja (defactinib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.
Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.
Defactinib is a selective oral inhibitor of focal adhesion kinase (FAK), disrupting compensatory signaling that tumors use to escape MAPK pathway blockade, synergizing with avutometinib.
Diarrhea (56%), Nausea (48%), Fatigue (42%), Rash (38%), Vomiting (32%), Edema (28%), Increased Creatinine (22%) Diarrhea 56% Nausea 48% Fatigue 42% Rash 38% Vomiting 32% Edema 28% Increased Creatinine 22%