Posted by Michael Wonder on 04 Jan 2023
Enhertu type II variation application validated by EMA for the treatment of HER2 mutant metastatic non-small-cell lung cancer
4 January 2022 - Submission based on DESTINY-Lung02 and DESTINY-Lung01 Phase 2 trial results which showed Daiichi Sankyo and AstraZeneca’s Enhertu demonstrated a clinically meaningful tumour response.
Daiichi Sankyo today announced that the EMA has validated the Type II Variation application for Enhertu (trastuzumab deruxtecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic non-small-cell lung cancer whose tumours have activating HER2 (ERBB2) mutations and who have received a prior systemic therapy.
