Truqap^™ (capivasertib – AstraZeneca Pharmaceuticals) tablets were approved by the U.S. Food and Drug Administration (FDA) on Nov. 16, 2023. It is indicated to treat adults who have breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor-2 negative (HER2-). The cancer also must have genetic mutations in phosphoinositide 3-kinase CA (PIK3CA), AKT serine/threonine kinase 1 (AKT1), or phosphatase and tensin homolog (PTEN). On the same day, the FDA approved a diagnostic test, FoundationOne^®CDx, to identify patients whose cancers are likely to respond to Truqap. The patient must have been treated for metastatic breast cancer with one or more endocrine therapies. Appropriate patients whose cancer has returned one year or less after they finished drug treatment that followed surgery also are candidates for treatment with Truqap. It is taken on 28-day cycles with a dose of 400mg twice a day for only the first four days of each week. Fulvestrant is given by intramuscular (IM) injections of 500mg on days one and 15 of the first cycle, and then just on the first day of each subsequent cycle. Launch and pricing plans for Truqap have not yet been released. Look here for its complete prescribing information.

At a Glance

• Brand (Generic) Name: Truqap (capivasertib)
• Manufacturer: AstraZeneca
• Date Approved: Nov. 16, 2023
• Indication: For use in combination with fulvestrant for the treatment of adult patients with HR-positive/HER2-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
• Dosage Forms Available: 160mg and 200mg oral tablets
• Launch Date: The launch date is unknown at this time.
• Estimated Annual Cost: Pricing information is not yet available.
• The most common cancer among women, breast cancer affects about 300,000 new patients, including around 3,000 men, in the U.S. each year, according to the American Cancer Society (ACS).
• Approximately two-thirds of advanced breast cancer cases are HR+/HER2-, and as many as 50% of metastatic breast cancers have at least one of the mutations that Truqap targets.
• Truqap blocks specific enzymes that contribute to cancer cell growth and spread.
• In a clinical trial, the average progression-free survival (PFS) for patients taking Truqap along with receiving fulvestrant was 7.3 months versus 3.1 months for patients using fulvestrant and taking a placebo tablet.
• Side effects from therapy included abnormal blood counts, diarrhea, fatigue, nausea, sores in the mouth, and vomiting.   
• Blood levels of glucose and lipids should be monitored frequently because taking Truqap may increase either or both.
• Currently, chemotherapy (chemo) with one of multiple approved regimens may be used for metastatic breast cancer that does not respond to endocrine therapy.
• Usually in combination with an aromatase inhibitor, drugs that inhibit cyclin-dependent kinases 4 and 6 (CDK4/6) also can be used to treat HR+/HER2- breast cancer. The ones approved in the U.S are Ibrance^® (palbociclib) plus letrozole, Kisqali^® (ribociclib) plus an aromatase inhibitor and Verzenio^™ (abemaciclib) plus fulvestrant. Typically, resistance develops rapidly to the regimens, though.
• Some targeted therapies and immunotherapies also are indicated for HR+/HER2- metastatic breast cancers that have certain genetic mutations, but Truqap is the only one specific for all the forms of AKT plus PIK3CA and PTEN.
• The FDA used its Priority Review process to approve Truqap, which also is included in Project Orbis, an international partnership that allows simultaneous regulatory review in multiple countries.