Enhertu Approved as a New Second-Line Option for HER2-Positive Breast Cancer in Japan

On November 24, 2022, Daiichi Sankyo Co., Ltd. announced that Enhertu (Trastuzumab deruxtecan) has received approval in Japan for an expanded indication. The HER2-directed antibody-drug conjugate (ADC) is now authorized for the treatment of adult patients with HER2-positive unresectable or recurrent breast cancer who have received prior chemotherapy.

Expansion of Indications

Previously, Enhertu was restricted to patients for whom "standard treatments were difficult." This latest approval removes that restriction, effectively establishing Enhertu as a standard second-line treatment option for patients with HER2-positive breast cancer whose disease has progressed after an initial regimen (typically including Trastuzumab and a taxane).

Clinical Evidence: DESTINY-Breast03

The approval is primarily based on the results of the DESTINY-Breast03 Phase 3 clinical trial, a global study comparing Enhertu with T-DM1 (Kadcyla). The trial demonstrated that Enhertu significantly improved progression-free survival and showed a strong trend toward improved overall survival.

Clinical Impact

This regulatory milestone provides HER2-positive breast cancer patients in Japan with earlier access to a highly effective therapy. Daiichi Sankyo emphasized that this approval represents a major step forward in delivering better care and more options for those fighting advanced breast cancer.

Source: Daiichi Sankyo Press Release - Enhertu Expanded Indication in Japan

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