PV Bulletin

TGA updates indication for TRUQAP (capivasertib)

The TGA has revised the indication for TRUQAP (capivasertib) to restrict its use to patients with certain genetic alterations.

Primary source: Safety monitoring and information

PV Impact Brief

Urgency: HighConfidence: high

What changed

The indication for TRUQAP (capivasertib) has been updated to specify that it should only be used in patients with one or more PIK3CA, AKT1, or PTEN alterations.

Why it matters

This change ensures that TRUQAP is used in a manner that reflects the latest clinical findings, improving the benefit-risk balance for patients while reducing potential harm.

Action needed

Regulatory teams must update product labeling to reflect the new indication and assess signal management considerations for capivasertib.

Relevant for
Regulatory Intelligence LeadLabeling Lead
Processes impacted
LabelingSignal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Aug 28, 2026

Full briefing

Practical implication

Regulatory teams must update product labeling to reflect the new indication and assess signal management considerations for capivasertib.

The TGA has approved an amendment to the indication for TRUQAP (capivasertib), now limiting its use to patients with PIK3CA, AKT1, or PTEN alterations based on new clinical data assessment.

What changed: The indication for TRUQAP (capivasertib) has been updated to specify that it should only be used in patients with one or more PIK3CA, AKT1, or PTEN alterations.

Why it matters: This change ensures that TRUQAP is used in a manner that reflects the latest clinical findings, improving the benefit-risk balance for patients while reducing potential harm.

Practical implication: Regulatory teams must update product labeling to reflect the new indication and assess signal management considerations for capivasertib.

View original source

  • Source: TGA Safety Alerts - News feed
  • Published at source: 2026-08-28T00:00:00.000Z
  • Discovered by monitor: 2026-08-29T04:56:38.464Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Labeling#Safety Signals#Australia#Source-ingestion#Regulator-monitor#Tga.gov.au

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