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AstraZeneca's Enhertu Receives Fourth U.S. Breakthrough Therapy Designation

AstraZeneca Plc (AZN), on Monday, announced that its cancer drug Enhertu has been granted Breakthrough Therapy Designation by the FDA for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens. This marks the fourth Breakthrough Therapy Designation for the drug.

The Breakthrough Therapy Designation was granted based on results from a pivotal study, dubbed DESTINY-Breast03, in which Enhertu reduced the risk of disease progression or death by 72% compared to Roche's approved breast cancer drug Kadcyla (trastuzumab emtansine).

The FDA's Breakthrough Therapy Designation is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need.

Enhertu, a HER2-directed antibody drug conjugate, jointly developed by AstraZeneca and Tokyo-headquartered Daiichi Sankyo Company Limited, was granted accelerated approval by the FDA in December 2019 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 the metastatic setting.

The drug received regular approval in the U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen in January of this year.

Enhertu is also being explored as a monotherapy across multiple HER2 targetable cancers including breast, gastric, lung and colorectal cancers.

Enhertu received Breakthrough Therapy Designation in HER2-mutant metastatic non-small cell lung cancer and in HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab last May and in HER2-positive metastatic breast cancer in 2017.

In the first half of 2021, the drug brought home sales of $89 million for AstraZeneca.

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