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News
China's drug regulator has approved T-DXd (Enhertu) as an adjuvant treatment for HER2-positive early breast cancer patients with residual invasive disease after neoadjuvant therapy. The decision is backed by DESTINY-Breast05 trial data showing T-DXd cut the risk of recurrence or death by 53% compared to the current standard, T-DM1. The drug is now approved in multiple countries, with reviews ongoing in the EU, Japan, and Switzerland.
China's National Medical Products Administration (NMPA) has approved fam-trastuzumab deruxtecan (T-DXd; Enhertu) for the adjuvant treatment of adults with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant therapy. The approval adds China to a growing list of countries — including the US, Brazil, Canada, and India — that have greenlit this indication, while the EU, Japan, and Switzerland are still reviewing it. Europe's CHMP has already issued a positive recommendation based on the same data.
The approval is anchored in results from the phase 3 DESTINY-Breast05 trial, a global head-to-head study comparing T-DXd against T-DM1 (the current adjuvant standard of care) in high-risk patients with residual disease after neoadjuvant chemotherapy and HER2-targeted therapy.
By the Numbers:
Why it matters: For HER2+ early breast cancer patients who don't achieve a complete response to neoadjuvant therapy, the risk of recurrence remains high. T-DXd's dramatic improvement over T-DM1 could redefine post-surgery care globally, offering patients a stronger shot at long-term, disease-free survival.
