Japanese healthcare company Daiichi Sankyo Co Ltd (TYO:4568) said on Thursday that the European Medicines Agency (EMA) has validated the Type II Variation marketing authorisation application for ENHERTU (trastuzumab deruxtecan) for adult patients with HER2 positive (IHC 3+) unresectable or metastatic solid tumours who have received prior treatment.
This validation marks the start of the EMA's scientific review process by the Committee for Medicinal Products for Human Use.
ENHERTU is a HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and jointly developed with biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN). The submission is based on three phase 2 trials -- DESTINY-PanTumor02, DESTINY-CRC02, and DESTINY-Lung01 -- in which ENHERTU showed clinically meaningful responses across multiple tumour types.
If approved, ENHERTU would become the first HER2-directed therapy and ADC to receive a tumour-agnostic indication in the European Union, offering a potential treatment option for patients with limited alternatives.
Saol Therapeutics receives US FDA Complete Response Letter for SL1009 (DCA) in PDCD
Amneal's risperidone extended-release injectable suspension approved by US FDA
Brain+ pilot shows Ayla therapy boosts cognitive outcomes in dementia care
Ascelia Pharma files NDA with FDA for liver imaging drug Orviglance
Biophytis secures EMA clearance to advance Phase 2 obesity trial
Valneva reports strong Phase 2 booster results for Lyme disease vaccine candidate VLA15
Eisai begins rolling sBLA to US FDA for initiation dosing of LEQEMBI IQLIK
First FDA acceptance to waive clinical efficacy studies for monoclonal antibody biosimilars
BeOne Medicines reports positive topline data for sonrotoclax in mantle cell lymphoma
Cinclus Pharma to launch Phase III trial of linaprazan glurate in erosive GERD