Daiichi Sankyo and AstraZeneca’s ENHERTU® Secures US FDA Approval for Advanced HER2 Low and Ultralow Breast Cancer
Tuesday, January 28, 2025
Daiichi Sankyo and AstraZeneca’s ENHERTU® has received US FDA approval for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer.
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally.
DESTINY-Breast06 is a global phase 3 trial comparing ENHERTU (5.4 mg/kg) with investigator’s choice of chemotherapy (capecitabine, paclitaxel, or nab-paclitaxel) in patients with HR-positive, HER2 low or HER2 ultralow advanced or metastatic breast cancer.
Eligibility is determined using an FDA-approved diagnostic test, and the treatment is indicated for patients whose disease has progressed following one or more endocrine therapies in the metastatic setting.
ENHERTU is a HER2-directed antibody-drug conjugate (ADC) developed by Daiichi Sankyo and jointly commercialised with AstraZeneca.
The approval is based on findings from the DESTINY-Breast06 phase 3 trial, which demonstrated a significant reduction in disease progression or death compared to chemotherapy in patients with chemotherapy-naïve HR-positive HER2 low or HER2 ultralow metastatic breast cancer.
The approval marks a significant milestone in the treatment of HR-positive metastatic breast cancer, offering a new option for patients with HER2 low or HER2 ultralow expression.
The therapy’s ability to target a broader spectrum of HER2 expression levels highlights the importance of advanced diagnostic testing for personalised treatment approaches.
Daiichi Sankyo and AstraZeneca have committed to supporting patients prescribed ENHERTU, offering financial assistance and access through dedicated programmes.
Following this approval, Daiichi Sankyo will receive a $175 million milestone payment from AstraZeneca as part of their collaboration agreement.
Source: daiichisankyo.com
