The NMPA has approved Enhertu (HER2-directed ADC) in China as a monotx. for adult patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens
The approval was based on the P-III trial (DESTINY-Breast03) results evaluating Enhertu (5.4mg/kg) vs T-DM1 in 524 patients at multiple sites in Asia, EU, North America, Oceania & South America which showed a 72% reduction in risk of disease progression or death. The safety profile was consistent with prior trials with no new safety concerns
Enhertu (5.4mg/kg) was approved in 40+ countries for unresectable or metastatic HER2+ breast cancer, based on (DESTINY-Breast03) trial results
Ref: AstraZeneca | Image: AstraZeneca
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