Truqap capivasertib

Drug Class

AKT kinase inhibitor

Mechanism

Inhibits all three isoforms of the serine/threonine kinase AKT (AKT1, AKT2, and AKT3) to block downstream signaling pathways that promote tumor growth and cell survival.

Approved Indication

FDA-approved in combination with fulvestrant for adult patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, following progression on endocrine-based regimens.

What This Means For Patients

Truqap is a targeted AKT inhibitor for HR-positive, HER2-negative advanced breast cancers with PIK3CA, AKT1, or PTEN mutations. It is approved by the FDA and accessible inside Boao Lecheng.

Regulatory Approvals

• FDA — approved (2023) — label
• EMA — approved (2024) — source

Pivotal Clinical Evidence

• CAPItello-291 — Turner et al., N Engl J Med 2023 (NCT04305496) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/218197s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/truqap