MSD and LaNova Medicines Enter Exclusive Global License Agreement for Novel Cancer Therapy, LM-299

Promising CAR T Cell Therapies from BMS and Cabaletta Bio Show Potential for Durable Remission in Severe Lupus

FDA Grants Accelerated Approval to PTC Therapeutics' KEBILIDI™, the First Gene Therapy for AADC Deficiency in the U.S.

Association for Molecular Pathology Publishes Joint Consensus Report on SARS-CoV-2 Genomic Surveillance for Hospitals and Public Health Laboratories

Philips India Unveils Advanced Azurion Imaging System to Revolutionize Cardiac and Neurovascular Care

Tempus AI Study Highlights Benefits of Dual RNA and DNA Sequencing for Advanced Lung Cancer

Ontada and Datavant Partner to Expand Access to Real-World Oncology Data for Accelerated Cancer Innovation

Tempus AI and Flatiron Health Partner to Integrate Genomic Testing into OncoEMR for Enhanced Oncology Care

Flare Therapeutics and Roche Forge Strategic Partnership to Discover Precision Oncology Therapies Targeting Transcription Factors

FDA Approves Autolus’s CAR-T Therapy Aucatzyl for Relapsed or Refractory B-ALL in Adults

Biosimilars: Expanding Access to Precision Medicine through Affordable Biologic Therapies

IDEAYA Biosciences Secures Exclusive Worldwide License for Biocytogen’s BsADC Program IDE034 for Solid Tumor Treatment

Seer and Thermo Fisher Scientific Announce Strategic Collaboration to Advance Proteomics with Integrated Platform Solution

SystImmune Secures FDA Clearance for IND Application of Novel ADC Therapy BL-M17D1 for Advanced Solid Tumors

Medicare Expands Coverage for Adaptive Biotechnologies' clonoSEQ® MRD Test to Include Mantle Cell Lymphoma

Home
/
update
/
details

EMA Validates Type II Variation Application for ENHERTU® in HER2 Low and Ultralow Metastatic Breast Cancer After Prior Endocrine Therapy

NextEdge Admin

19 Aug 2024

2 min 3 sec

Daiichi Sankyo announced that the European Medicines Agency (EMA) has validated the Type II Variation application for ENHERTU® (trastuzumab deruxtecan) as a monotherapy for treating adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer who have previously received at least one endocrine therapy in the metastatic setting. ENHERTU, a HER2-directed DXd antibody-drug conjugate (ADC), was developed by Daiichi Sankyo in collaboration with AstraZeneca .

The validation signifies that the application is complete, initiating the EMA’s Committee for Medicinal Products for Human Use (CHMP) scientific review process. This submission is supported by data from the DESTINY-Breast06 phase 3 trial, presented during a late-breaking oral session at the 2024 American Society of Clinical Oncology (ASCO24) Annual Meeting.

“This submission extends our existing indication for ENHERTU in HER2 low metastatic breast cancer and could allow its use in an earlier disease setting, reaching a broader patient population that includes those with HER2 ultralow expression,” said Ken Takeshita, MD, Global Head of R&D at Daiichi Sankyo. The company is working closely with the EMA to potentially make this treatment available to more patients in the EU. Additional regulatory submissions for this indication are also underway globally.