TGA reins in breast cancer label

The TGA has narrowed the patient population eligible for AstraZeneca’s breast cancer drug Truqap, after Australia initially granted approval for a broader population than other major jurisdictions, including the US and Europe.

Truqap, which belongs to a class of drugs known as AKT inhibitors, was reviewed under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among international partners.

In 2024, the TGA approved Truqap for use in combination with fulvestrant, for the treatment of patients with HER+/HER- locally advanced or metastatic breast cancer following recurrence on or after an endocrine based regimen on the condition that the company provides all outstanding interim and final clinical study reports for this indication.