FDA Decision On Expanded Indication For AstraZeneca/Daiichi's Breast Cancer Drug In Q2

AstraZeneca (AZN) (AZN.L) and Japanese pharmaceutical company Daiichi Sankyo said on Monday that their supplemental Biologics License Application seeking approval of Enhertu for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen has been accepted for priority review by the FDA.

The FDA decision on the proposed new indication for Enhertu is expected in the second quarter of this year.

Enhertu, a HER2-directed antibody drug conjugate, jointly developed by AstraZeneca and Daiichi Sankyo, is being reviewed under the Real-Time Oncology Review (RTOR) program and Project Orbis.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca said: "This review across geographies and the Priority Review in the US as part of Project Orbis is so important because it speaks to the transformative potential of Enhertu based on the unprecedented progression-free survival benefit in this setting. The news reinforces the importance of bringing this potential new option to patients as quickly as possible."

The drug is already approved for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in more than 30 countries.

In the first half of 2021, Enhertu generated sales of $89 million for AstraZeneca.

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