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    AZN   GB0009895292

ASTRAZENECA PLC

(AZN)
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AstraZeneca Says FDA Granted Breakthrough-Therapy Designation for Cancer Treatment Enhertu

10/04/2021 | 12:32am EST

By Anthony O. Goriainoff

AstraZeneca PLC said Monday that the U.S. Food and Drug Administration granted its cancer treatment Enhertu a breakthrough-therapy designation for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.

HER2 refers to a breast cancer that tests positive for a protein called human epidermal growth factor receptor 2.

The U.K. pharmaceutical company said that the FDA granted the designation based on the DESTINY-Breast03 Phase 3 trial, and that this is Enhertu's second BTD in breast cancer, bringing the total number to four.

The company said Enhertu's trial showed it reduced the risk of disease progression or death by 72% in patients with HER2-positive metastatic breast cancer.

The BTD designation is designed to accelerate the development and the regulatory review of potential new medicines that are intended to treat a serious condition, the company said.

Enhertu is a HER2-directed antibody drug conjugate that is being developed jointly by AstraZeneca and Daiichi Sankyo Co.

Write to Anthony O. Goriainoff at anthony.orunagoriainoff@dowjones.com

(END) Dow Jones Newswires

10-04-21 0232ET

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Financials (USD)
Sales 2021 35 919 M - -
Net income 2021 3 423 M - -
Net Debt 2021 25 253 M - -
P/E ratio 2021 37,9x
Yield 2021 2,53%
Capitalization 173 B 172 B -
EV / Sales 2021 5,51x
EV / Sales 2022 4,51x
Nbr of Employees 76 100
Free-Float 96,4%
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Number of Analysts 25
Last Close Price 111,38 $
Average target price 137,74 $
Spread / Average Target 23,7%
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Pascal Soriot Chief Executive Officer & Executive Director
Aradhana Sarin Chief Financial Officer & Executive Director
Leif Valdemar Johansson Non-Executive Chairman
Menelas NICOLAS Pangalos EVP-Biopharmaceuticals Research & Development
Pam P. Cheng Executive VP-Operations & Information Technology
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