FDA accepts AstraZeneca’s NDA for breast cancer combination therapy

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review.

The combination therapy is intended to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in adult patients, after recurrence or progression on or after an endocrine-based regimen.

Capivasertib is an investigational oral therapy and a potent adenosine triphosphate (ATP)-competitive inhibitor of all three AKT [protein kinase B] isoforms (AKT1/2/3).

The regulator will announce its decision during the fourth quarter of 2023.

AstraZeneca stated that its NDA is being reviewed under Project Orbis.

AstraZeneca Oncology research and development executive vice-president Susan Galbraith stated: “This priority review decision underscores the potential of capivasertib to extend the effectiveness of endocrine-based treatment approaches for patients with HR-positive breast cancer who experience tumour progression on, or resistance to, these widely used therapies.

“We look forward to working with the FDA to bring this potential first-in-class AKT inhibitor to patients as quickly as possible.”

The submission of the NDA was based on the findings of the CAPItello-291 Phase III trial.

The randomised double-blind trial was designed to assess the efficacy of capivasertib along with FASLODEX against placebo plus FASLODEX.

The combination of capivasertib and FASLODEX showed a 40% reduction in disease progression risk or mortality in the overall trial population compared to placebo plus FASLODEX.

Earlier in 2023, the US FDA granted its fast track designation to capivasertib for the same indication.