The Food and Drug Administration (FDA) has approved Truqap (capivasertib) with the chemotherapy fulvestrant for the treatment of adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations and who have progressed on at least one endocrine-based regimen in the metastatic setting or recurrence at or within one year of completing adjuvant therapy.
The FDA also announced that it has approved the FoundationOne CDx assay companion diagnostic device for patients with breast cancer for treatment with the combination, according to a release from the Agency.
The approval was based on the results of the CAPItello-291 trial, in which 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer, 289 of whom had PIK3CA/AKT1/PTEN-alterations, received either Truqap or placebo.
Among the patients with the PIK3CA/AKT1/PTEN-altered tumors, the median progression-free survival (the time a patient lives following treatment without their disease spreading or worsening) was 7.3 months in the Truqap and chemotherapy cohort and 3.1 months in the placebo and chemotherapy cohort.
Common side effects reported in at least 20% of patients included diarrhea, cutaneous adverse reactions (skin reactions), increased random glucose, decreased lymphocytes (a type of white blood cell), decreased hemoglobin (a protein in red blood cells), increased fasting glucose, nausea, fatigue, decreased leukocytes (a type of white blood cell), increased triglycerides (fat that circulates in the blood), decreased neutrophils (a type of white blood cell), increased creatine, vomiting and stomatitis (inflammation and swelling inside the mouth).
According to the FDA, the recommended dose of Truqap is 400 milligrams twice daily, with doses spaced approximately 12 hours apart, with or without food, for four days, followed by three days off, until disease progression or unacceptable toxicity.
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