AstraZeneca gets EU nod for AKT inhibitor Truqap in breast cancer

2024-06-20

临床3期上市批准临床结果临床终止

AstraZeneca’s Truqap (capivasertib) became the first AKT inhibitor approved in the EU for breast cancer patients with one or more PIK3CA/AKT1/PTEN-alterations. Dave Fredrickson, executive vice president of the company’s oncology business unit, noted Thursday that the authorisation “represents a significant step forward in providing an important new treatment option for patients in need of new, innovative therapies.”

Specifically, Truqap is indicated in combination with Faslodex (fulvestrant) for the treatment of adults with oestrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. The drug already has similar approvals in the US and Japan.

Clearance from the European Commission was based on results from the Phase III CAPItello-291 trial in which the combination of Truqap and Faslodex reduced the risk of disease progression or death by 50% versus Faslodex in combination with placebo in patients with tumours harbouring PI3K/AKT/PTEN-alterations. A regulatory application based on the data is also under review in China.

Truqap, which was discovered under a collaboration with Otsuka’s Astex Therapeutics unit, is also being studied in prostate cancer. However, efforts in triple-negative breast cancer were recently dealt a blow with the failure of the Phase III CAPItello-290 trial.

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