Enhertu granted priority review in US for patients with HER2-positive metastatic breast cancer
pharmafile | January 18, 2022 | News story | Manufacturing and Production |
Enhertu, manufactured by AstraZeneca and Daiichi Sankyo, has been accepted for the treatment of adult patients in the US with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen. The application has also been granted Priority Review.
The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.
Breast cancer is the most common type of cancer worldwide, and more than two million cases were diagnosed in 2020, resulting in nearly 685,000 deaths globally. Approximately one in five cases of breast cancer are considered HER2-positive.
Enhertu is a HER-2 directed antibody drug conjugate (ADC) 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 regimensin more than 30 countries based on the results from the DESTINY-Breast01 trial.
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.”
Ken Takeshita, Global Head, R&D, Daiichi Sankyo, added: “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 programs. The FDA’s prioritization 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.”
Lina Adams
