Truqap FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 21, 2023.
FDA Approved: Yes (First approved November 16, 2023)
Brand name: Truqap
Generic name: capivasertib
Dosage form: Tablets
Company: AstraZeneca
Treatment for: Breast Cancer
Truqap (capivasertib) is an AKT inhibitor used in combination with fulvestrant for the treatment of advanced hormone receptor-positive breast cancer.
- Truqap is indicated, in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
- HR-positive breast cancer is the most common subtype of breast cancer and mutations in PIK3CA, AKT1 and alterations in PTEN occur frequently. The growth of HR-positive breast cancer cells is often driven by estrogen receptors, and many patients with advanced HR-positive breast cancer develop resistance to first-line CDK4/6 inhibitors and endocrine therapies.
- Truqap is a first-in-class adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT1/2/3). AKT is an enzyme that plays a key role in the PI3K/AKT tumor cell survival pathway and inhibition of AKT with Truqap is associated with a reduction in tumor cell proliferation.
- FDA approval of Truqap was based on the results from the CAPItello-291 Phase III trial which showed that capivasertib in combination with fulvestrant demonstrated a 40% reduction in the risk of disease progression or death versus placebo plus fulvestrant in the overall trial population, and a 50% reduction in the AKT pathway biomarker-altered population.
- Truqap tablets are administered orally twice daily, with or without food, for 4 days followed by 3 days off.
- Warnings and precautions associated with Truqap include hyperglycemia, diarrhea, cutaneous adverse reactions, and embryo-fetal toxicity.
- Common adverse reactions include diarrhea, cutaneous adverse reactions, nausea, fatigue, vomiting and stomatitis. Common laboratory abnormalities include increased random glucose, decreased lymphocytes, decreased hemoglobin, increased fasting glucose, decreased leukocytes, increased triglycerides, decreased neutrophils, and increased creatinine.
Development timeline for Truqap
Further information
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