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# FDA OKs AstraZeneca Breast Cancer Drug
- URL: https://www.fdaweb.com/fda-oks-astrazeneca-breast-cancer-drug/
- Published: 2023-11-17T12:00:00.000Z
- Updated: 2026-09-14T14:16:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155819

FDA has approved an AstraZeneca NDA for Truqap (capivasertib) for use with fulvestrant in 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 (FoundationOne CDx assay). The drug is intended for use following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy, an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-fulvestrant-breast-cancer?utm%5Fmedium=email&utm%5Fsource=govdelivery) says.

Approval was based on data from the CAPItello-291 (NCT04305496) placebo-controlled, multicenter trial in 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer. In the study, 289 patients had tumors with PIK3CA/AKT1/PTEN-alterations, and the major efficacy outcome measure was investigator-assessed progression-free survival (PFS), FDA says. “In the 289 patients with PIK3CA/AKT1/PTEN-altered tumors, the median PFS was 7.3 months (95% CI: 5.5, 9.0) in the capivasertib-fulvestrant group and 3.1 months (95% CI: 2.0, 3.7) in the placebo-fulvestrant group (Hazard Ratio \[HR\] 0.50 \[95% CI: 0.38, 0.65\] p-value< 0.0001),” it says.

Regarding safety, the most common adverse reactions that were reported in 20% or more patients included diarrhea, cutaneous adverse reactions, increased random glucose, decreased lymphocytes, decreased hemoglobin, increased fasting glucose, nausea, fatigue, decreased leukocytes, increased triglycerides, decreased neutrophils, increased creatinine, vomiting and stomatitis.