AstraZeneca and Daiichi Sankyo’s Enhertu has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor-positive, HER2-low or HER2-ultralow breast cancer, as determined by a Food and Drug Administration-approved test, that has progressed on one or more endocrine therapies in the metastatic setting.

Enhertu is already approved in more than 70 countries, including the US, for patients with HER2-low metastatic breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu is already approved in more than 70 countries, including the US, for patients with HER2-low metastatic breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial. Regulatory applications are under review in the EU, Japan and several other countries based on the DESTINY-Breast06 results.

The DESTINY-Breast06 Phase III trial

The approval was granted by the FDA after securing Priority Review and Breakthrough Therapy Designation and was based on results from the DESTINY-Breast06 Phase III trial.

“Building on the practice-changing previous approvals for Enhertu, this new approval brings this important medicine to an earlier treatment setting and a broader patient population with HER2-expressing metastatic breast cancer. The approval also highlights the importance of testing metastatic breast cancer tumours for detectable staining with a standard IHC test to identify those who may be eligible for treatment with Enhertu following endocrine therapy,” says Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca.

Jointly developed and commercialized by AstraZeneca and Daiichi Sankyo

Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.

Following this approval for Enhertu in the US, an amount of USD 175 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment.

Following this approval for Enhertu in the US, an amount of USD 175 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for the HER2-low and HER2-ultralow chemotherapy-naïve breast cancer indication. The milestone will be capitalized as an addition to the upfront payment made by AstraZeneca to Daiichi Sankyo in 2019 and subsequent capitalized milestones and will be amortized through the profit and loss statement.