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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.