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

Enhertu Receives Approval in China for HER2-Positive Gastric and Gastroesophageal Junction Cancer

NextEdge Admin

14 Aug 2024

2 min 6 sec

China’s National Medical Products Administration (NMPA) has granted conditional approval to AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) for the treatment of previously treated patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer. This decision is grounded in data from two Phase II trials, DESTINY-Gastric06 and DESTINY-Gastric01.

The DESTINY-Gastric06 trial involved 95 Chinese patients with HER2-positive gastric cancer and showed an objective response rate of 28.8% and a median progression-free survival of 5.7 months. Meanwhile, the DESTINY-Gastric01 study, conducted with participants from Japan and South Korea, demonstrated a 40.5% response rate with Enhertu, compared to 11.3% with chemotherapy. Additionally, the median overall survival was 12.5 months for patients on Enhertu, significantly higher than the 8.4 months observed with chemotherapy.

Full approval of Enhertu for this indication will require further confirmation of its clinical benefits through additional trials.

Dave Fredrickson, executive vice president of the oncology business unit at AstraZeneca, highlighted the significance of this approval, noting that China represents over one-third of the global gastric cancer burden, with most cases diagnosed at an advanced stage. He emphasized that this approval brings a much-needed targeted treatment option to patients with HER2-positive metastatic gastric cancer in China, reflecting AstraZeneca’s commitment to expanding access to innovative cancer therapies worldwide.