FDA Accepts sBLA for Enhertu in Low HER2 Breast Cancer


If approved, Enhertu would offer a treatment option for patients with breast cancer who have a lower expression of HER2. The PDUFA action date is during the fourth quarter of the 2022.

The FDA has accepted the supplemental biologics license application (sBLA) of Enhertu (famtrastuzumab deruxtecan-nxki) to treat adult patients with metastatic breast cancer with low HER2 expression. The application has been granted priority review, and the Prescription Drug User Fee Act date (PDUFA) action date is during the fourth quarter of the 2022.

The sBLA is being reviewed under the Real-Time Oncology Review (RTOR) program and Project Orbis, two initiatives of the FDA designed to bring cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application. Project Orbis provides a framework for concurrent submission and review of oncology medicines among participating international partners.

Enhertu is an engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

Susan Galbraith, MBBChir, Ph.D.

Susan Galbraith, MBBChir, Ph.D.

“For more than two decades, only patients with HER2 positive breast cancer have been able to benefit from HER2 targeted therapies,” Susan Galbraith, MBBChir, Ph.D., executive vice president, Oncology R&D, at AstraZeneca said in a press release. “If approved, Enhertu will redefine how we classify and treat metastatic breast cancer, enabling patients whose tumors have lower levels of HER2 expression the opportunity to benefit from a HER2 directed therapy.”

The sBLA application is based on data from the DESTINY-Breast04 phase 3 trial recently presented at the American Society of Clinical Oncology Annual Meeting in June 2022 and published in The New England Journal of Medicine.

In DESTINY-Breast04, Enhertu showed clinically meaningful efficacy in progression-free survival (PFS) and overall survival (OS) in previously treated patients with HER2 low unresectable and/or metastatic breast cancer with either hormone receptor positive or negative disease versus standard of care physician’s choice of chemotherapy. The safety profile was consistent with previous clinical trials with no new safety concerns identified.

Related: FDA Accepts sBLA of Enhertu to Treat Metastatic Lung Cancer

In April 2022, the FDA also accepted an sBLA for Enhertu to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 mutation. The application has also been granted priority review. The PDUFA date for this indication is during the third quarter of the 2022.

Enhertu is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer. It is also approved in several countries to treat HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

In May 2022, the FDA granted full approved Enhertu for earlier use in metastatic breast cancer, and the accelerated approval was converted to a regular approval.

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