Enhertu (ADC) for earlier stage cancers soon!
“We are excited to have submitted a second application this year seeking approval for trastuzumab deruxtecan for a potential third indication in Europe,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “With this specific application, we look forward to working closely with the EMA to support the review of trastuzumab deruxtecan to be used in an earlier setting for patients with HER2 positive metastatic breast cancer.
Trastuzumab deruxtecan (5.4 mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens based on the results from the DESTINY-Breast01 trial.”
https://www.businesswire.com/news/home/20211223005346/en/Trastuzumab-Deruxtecan-Type-II-Variation-Application-Validated-by-EMA-for-Patients-with-HER2-Positive-Metastatic-Breast-Cancer-Treated-with-a-Prior-Anti-HER2-Based-Regimen