HERNEXEOS® approved in China for previously treated patients with HER2-mutant advanced NSCLC
“It is encouraging to see the NMPA’s continued recognition of zongertinib’s potential. Breakthrough Therapy Designation for first-line use of zongertinib in China illustrates the urgent need in this patient population. It is a critical next step to making this therapy available to more patients in need,” said Shashank Deshpande, Chairman of the Board of Managing Directors at Boehringer Ingelheim. “Given the robust clinical evidence, regulatory approvals and breakthrough designation, we are confident that zongertinib has the potential to redefine the standard for treating HER2-driven cancers. Therefore, we have initiated clinical studies to evaluate this therapy in other cancers, including breast cancer and the tumor-agnostic setting.”
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“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.