AstraZeneca’s (AZ) AKT inhibitor Truqap (capivasertib) in combination with its endocrine therapy Faslodex (fulvestrant) has been approved by the US Food and Drug Administration (FDA) to treat a subset of advanced breast cancer patients.

The FDA’s decision specifically applies to adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer with at least one of three biomarker alterations: PIK3CA, AKT1 or PTEN. The US regulator has also approved the use of a companion diagnostic test to detect the relevant alterations.

Eligible patients will have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy.

Breast cancer is the most common cancer worldwide and more than 290,000 people in the US are expected to be diagnosed with breast cancer in 2023.

HR-positive breast cancer is the most common subtype, with over 65% of tumours considered HR-positive and HER2-low or HER2-negative, and mutations in PIK3CA, AKT1 and alterations in PTEN affect up to 50% of patients with advanced HR-positive breast cancer.

Endocrine therapies are widely used in this setting and often paired with CDK4/6 inhibitors. However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.

The US approval was supported by positive results from the late-stage CAPItello-291 trial, in which the Truqap combination reduced the risk of disease progression or death by 50% compared with Faslodex alone in patients with tumours harbouring PI3K/AKT pathway biomarker alterations.

Dave Fredrickson, executive vice president, oncology business unit, AZ, said the approval “reinforces the important role of the PI3K/AKT pathway in HR-positive breast cancer and the critical need to test patients at the time of diagnosis”.

He continued: “As a first-in-class medicine, this approval provides a critical new option for patients in the US with this specific type of disease and we look forward to bringing Truqap to the many breast cancer patients who can benefit across the globe.”

Regulatory applications for Truqap, which was discovered by AZ subsequent to a collaboration with Astex Therapeutics, in combination with Faslodex are also currently under review in the EU, China, Japan and several other countries, the company said.

https://www.pmlive.com/pharma_news/astrazenecas_truqap_plus_faslodex_receives_fda_approval_for_advanced_breast_cancer_1503910