ENHERTU® Type II Variation Application Validated by EMA for the Treatment of HER2 Mutant Metastatic Non-Small Cell Lung Cancer
Daiichi Sankyo has announced that the European Medicines Agency (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 (NSCLC) whose tumors have activating HER2 (ERBB2) mutations and who have received a prior systemic therapy.
ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. Validation confirms that the application is complete and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use. This application is based on data from the DESTINY-Lung02 phase 2 trial presented at the European Society for Medical Oncology (ESMO) 2022 Congress and the DESTINY-Lung01 phase 2 trial published in The New England Journal of Medicine with updated data also presented at ESMO 2022.
“ENHERTU is the first HER2 directed medicine shown to have a clinically meaningful tumor response in patients with previously treated HER2 mutant metastatic non-small cell lung cancer based on the results of the DESTINY-Lung02 and DESTINY-Lung01 trials,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “As there are no approved therapies targeting HER2 mutant non-small cell lung cancer in Europe, we look forward to working closely with the European Medicines Agency to potentially bring a new treatment option to these patients.”
- Treadwell Therapeutics Announces the Appointment of Roger Sidhu, M.D., as Chief Medical Officer Read more
- Personalis and Moderna Sign New Agreement to Leverage NeXT Platform™ in Personalized mRNA Cancer Vaccine Clinical Trials Read more
- Trelleborg to Expand its BioPharmaceutical Manufacturing Footprint in Europe Read more
- Revive Therapeutics Enters into Research Collaboration Agreement with PharmaTher for Development of MDMA Transdermal Patch Read more
- Accenture Expands Strategy Capabilities in Life Sciences with the Acquisition of Bionest Read more