AstraZeneca : ENHERTU Combination Approved In US For 1st-Line HER2-Positive Metastatic Breast Cancer

DAIICHI SANKYO

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(RTTNews) - AstraZeneca and Daiichi Sankyo's ENHERTU (fam-trastuzumab deruxtecan-nxki), in combination with pertuzumab, has received approval in the United States for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, as determined by a Food and Drug Administration (FDA)-approved test.

Following this approval, AstraZeneca will make a milestone payment of $150 million to Daiichi Sankyo for the 1st-line unresectable or metastatic HER2-positive breast cancer indication. Sales of ENHERTU in the US are recognized by Daiichi Sankyo.

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

The application was approved under the FDA's Real-Time Oncology Review (RTOR), an initiative designed to ensure that safe and effective treatments are made available to patients as early as possible.

This US regulatory submission was also reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. As part of Project Orbis, the ENHERTU plus pertuzumab 1st-line regimen is currently under review by Switzerland's Swissmedic (SMC) and Singapore's Health Sciences Authority (HSA). Separate regulatory applications are also under review in other countries.

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