KINASE INHIBITOR COMBINATION
Avmapki Fakzynja Co-Pack is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with recurrent low-grade serous ovarian cancer (LGSOC) that has a mutation (change) in the KRAS gene and who have previously received systemic therapy. As of May 2025, this approval is granted under the FDA’s accelerated approval program based on tumor response and duration of response. Continued approval may depend on results from further clinical trials confirming benefit. Avmapki Fakzynja Co-Pack is also known by its drug names, avutometinib and defactinib.
Avmapki Fakzynja Co-Pack is a combination of two kinase inhibitors. Kinase inhibitors block specific enzymes involved in cancer cell growth and survival. Scientists believe this combination works by targeting different pathways in cancer cells that help them grow and resist treatment, potentially slowing disease progression in KRAS-mutated LGSOC.
Prescribing information states that Avmapki is taken by mouth twice weekly (on Day 1 and Day 4) for the first three weeks of each four-week cycle. Fakzynja is taken by mouth twice daily for the first three weeks of each four-week cycle. The drug should be taken exactly as prescribed by a healthcare provider.
Common side effects of Avmapki Fakzynja Co-Pack include increased creatine phosphokinase (a muscle enzyme), nausea, fatigue, increased liver enzymes (aspartate aminotransferase and alanine aminotransferase), rash, diarrhea, muscle and joint pain, edema (fluid retention), anemia (low red blood cell count), increased blood bilirubin, high triglycerides, low lymphocyte count, abdominal pain, dyspepsia (indigestion), dermatitis acneiform (rash resembling acne), vitreoretinal disorders (eye disorders affecting the retina), increased alkaline phosphatase, stomatitis (mouth sores), pruritus (itching), low platelet count, constipation, dry skin, dyspnea (difficulty breathing), cough, urinary tract infection, and low neutrophil count.
Rare but serious side effects may include ocular toxicities (eye problems) including vision loss, severe skin reactions including photosensitivity (light sensitivity) and severe cutaneous adverse reactions (SCARs), hepatotoxicity (liver damage), rhabdomyolysis (muscle breakdown), and embryo-fetal toxicity (harm to an unborn baby).
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