Truqap

Treats hormone receptor (HR)-positive, human epidermal growth factor receptor 2…. NDA 218197, held by Astrazeneca. Capivasertib.

As of Nov 14, 2026, NDA 218197 (Truqap), held by Astrazeneca, was first approved by FDA on Nov 16, 2023, with 6 approved supplements and 0 published complete response letters.

First approved: Nov 16, 2023
Review: Priority
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TRUQAP is a kinase inhibitor indicated: HR-Positive, HER2-Megative Locally Advanced or Metastatic Breast Cancer

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-authorized 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below


Sep 16, 2026	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 12, 2026	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 16, 2023	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Products

2 strengths and forms


Truqap160MG · tablet;oral	Capivasertib	RxReference drug
Truqap200MG · tablet;oral	Capivasertib	RxReference drug

All 7 submissions, including labeling and manufacturing supplements


Sep 16, 2026	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 12, 2026	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 27, 2026	Supplement 5Labeling · Standard review	Approved	Letter
Nov 14, 2025	Supplement 3Labeling · Standard review	Approved	Letter Label
Feb 13, 2025	Supplement 2Labeling · Standard review	Approved	Label Letter
Sep 23, 2024	Supplement 1Labeling · Standard review	Approved	Label Letter
Nov 16, 2023	Original applicationNew molecular entity · Priority review	Approved	Review Label Letter

Promotion Letters

OPDP letters about this application's advertising

Untitled letter: TRUQAPSep 9, 2025

Identifiers

Application: NDA 218197
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters