China’s NMPA approval is based on results from the DESTINY-Breast03 clinical trial, in which Enhertu showed a 72% reduction in the risk of disease progression or death compared to trastuzumab emtansine (T-DM1)
Enhertu approved in China to treat breast cancer. (Credit: Myriams-Fotos from Pixabay)
AstraZeneca and Daiichi Sankyo announced that China’s National Medical Products Administration (NMPA) has approved Enhertu (trastuzumab deruxtecan) to treat a type of breast cancer in adults.
Enhertu is a precisely engineered HER2-directed antibody-drug conjugate (ADC), jointly developed, and commercialised by AstraZeneca and Daiichi Sankyo.
The drug is indicated for adult patients with unresectable or metastatic HER2-positive breast cancer, who have received one or more prior anti-HER2-based regimens.
The regulatory approval for Enhertu follows the Breakthrough Therapy Designation and Priority Review granted by China’s NMPA last year.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “The approval underscores our commitment to patients in China, where there has been an increased incidence rate of breast cancer, as we continue to explore the potential benefits of Enhertu earlier in the treatment of HER2-directed metastatic breast cancer and across HER2-targetable cancers.”
Daiichi Sankyo Asia, South and Central America (ASCA) Business Unit head Kiminori Nagao said: “With this approval, Enhertu has the potential to become a new standard of care in China in the second-line setting for patients with HER2-positive metastatic breast cancer.”
The NMPA approval is based on the results from DESTINY-Breast03, a global, head-to-head, randomised, open-label, registrational, Phase 3 clinical trial.
The study evaluated the efficacy and safety of Enhertu in patients with HER2-positive metastatic breast cancer, who were previously treated with trastuzumab and a taxane, when compared to trastuzumab emtansine (T-DM1).
In the study, Enhertu showed a 72% reduction in the risk of disease progression or death compared to T-DM1, with a safety profile consistent with previous clinical trials of Enhertu.
The most common adverse reactions observed in Phase 3 DESTINY-Breast03 trial participants include nausea, fatigue, vomiting, neutropenia, and alopecia.
In a separate development, AstraZeneca has closed its previously announced acquisition of US-based biopharmaceutical company CinCor Pharma (CinCor) for up to $1.8bn.
CinCor is developing novel therapeutics for resistant and uncontrolled hypertension, along with chronic kidney disease.