ENHERTU® Approved in Japan for Patients with HER2 Low or HER2 Ultralow Metastatic Breast Cancer Following at Least One Endocrine Therapy
“ENHERTU continues to transform the way breast cancer is treated, becoming the first HER2 directed medicine approved in Japan for patients with HR positive, HER2 low or HER2 ultralow metastatic breast cancer,” said Yuki Abe, PhD, Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. “This approval, which is the fifth indication for ENHERTU in Japan in five years, brings this important medicine to an earlier treatment setting and a broader patient population with lower levels of HER2 expression.”
Share:
More News
“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”
“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.