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AstraZeneca's Enhertu receives FDA grant for priority review

The approval is based on results from the DESTINY-Breast03 trial which showed a significant risk reduction of unresectable or metastatic HER-2 positive breast cancer progression


AstraZeneca and Daiichi Sankyo’s jointly developed drug, Enhertu (trastuzumab deruxtecan), has received a notification of acceptance of the supplemental Biologics License Application (sBLA), alongside a grant for priority review.

The drug is an HER2-directed antibody drug conjugate (ADC) and is a treatment option for adult patients in the US living with unresectable or metastatic breast HER2-positive breast cancer who have received a prior anti-HER2-formulated regimen.

Recorded as being the most common cancer worldwide – more than two million cases were diagnosed in 2020 – breast cancer-related deaths have accounted for nearly 685,000 deaths globally.
For patients diagnosed with HER2-positive metastatic breast cancer, initial treatment with trastuzumab and a taxane does not prevent disease progression.

The announcement allows for further available treatment options for patients in order to delay disease progression and support survival.

During the DESTINY-Breast03 trial, Enhertu demonstrated a 72% reduction in the risk of death or disease progression in patients with HER2-positive unresectable metastatic breast cancer which was previously treated with trastuzumab and a taxane.

The drug is receiving further evaluation in a comprehensive clinical development programme to assess the safety and effectiveness across various HER2 cancers, including lung, breast, gastric and colorectal cancers.

The sBLA is currently under review by two FDA programmes, the Real-Time Oncology Review (RTOR) and Project Orbis, which are designed to provide effective cancer treatments to patients as early as possible.

HER2 is a tyrosine kinase receptor growth-promoting protein presented on the surface of many types of tumours, including breast, lung, gastric and colorectal cancers and is often associated with poor breast cancer prognosis and aggressive disease.

Commenting on the latest developments, Susan Galbraith, executive vice president of Oncology R&D at 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.”

Speaking on behalf of the Daiichi Sankyo, Ken Takeshita, global head of R&D said: “This regulatory review of Enhertu in the US marks the first time this medicine is participating in both the Real-Time Oncology Review and Project Orbis programmes. The FDA’s prioritisation of our application underscores the potential of this medicine and the continued need to expedite the availability of new treatment options, while making it possible to potentially receive approvals in several countries concurrently.”

Article by
Fleur Jeffries

17th January 2022

From: Regulatory



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