AstraZeneca breast cancer drug gets breakthrough therapy designation

(Alliance News) - AstraZeneca PLC on Monday said its breast cancer treatment Enhertu has been ...

Alliance News 4 October, 2021 | 7:14AM
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(Alliance News) - AstraZeneca PLC on Monday said its breast cancer treatment Enhertu has been granted an additional breakthrough therapy designation in the US for the treatment of adult patients by the Food & Drug Administration.

The designation was granted for adults with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.

Enhertu, which has been jointly developed with Japanese pharmaceutical firm Daiichi Sankyo Co Ltd, has now been granted four breakthrough therapy designations, including two in breast cancer treatment.

"This is an important step in bringing Enhertu as a potential new option in earlier lines of treatment for HER2-positive metastatic breast cancer, given the urgent need to improve outcomes," commented Susan Galbraith, Oncology Research & Development executive vice president.

"This recognition by the FDA underscores the transformative possibility of Enhertu."

Breakthrough therapy designations are used by the FDA to accelerate the development of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The medicine needs to have shown encouraging clinical results that demonstrate "substantial improvement on a clinically significant endpoint over available medicines".

In trials, Enhertu demonstrated a 72% reduction in the risk of disease progression or death compared to rival drug T-DM1 in patients with HER2-positive unresectable and or metastatic breast cancer previously treated with trastuzumab and a taxane.

Breast cancer remains the most common cancer worldwide, with more than two million cases diagnosed in 2020, resulting in nearly 685,000 deaths globally. Around one in five cases of breast cancer are considered HER2-positive.

Shares in the FTSE 100 constituent were trading up 0.7% at 8,831.43 pence each in London on Monday morning.

By Will Paige; willpaige@alliancenews.com

Copyright 2021 Alliance News Limited. All Rights Reserved.

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Securities Mentioned in Article

Security Name Price Change (%) Morningstar
Rating
AstraZeneca PLC 11,946.00 GBX -0.67
Daiichi Sankyo Co Ltd 5,010.00 JPY 5.12

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