Registrational Pivotal Phase III Study of Olverembatinib for the First-Line Treatment of Patients with Ph+ ALL Approved by the CDE in China
“This approval for the pivotal Phase III study in newly diagnosed patients with Ph+ ALL marks a major milestone for the development of olverembatinib,” said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “TKIs combined with chemotherapy is a widely recognized standard treatment strategy for patients with Ph+ ALL, but no TKI has been approved for the first-line setting in this therapeutic area, thus potentially making olverembatinib the first TKI approved for the first-line treatment of Ph+ ALL in China. Fulfilling our mission of addressing unmet clinical needs in China and around the world, we will expeditiously advance the clinical development of olverembatinib in efforts to allow more patients to benefit from this novel therapeutic as soon as possible.”
Share:
More News
“Orphan Drug Designation for SOT106 underscores both the urgent need for new treatment options in osteosarcoma and the strength of our ADC platform,” said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. “Osteosarcoma is a devastating disease that has seen little therapeutic innovation over the past four decades. Treatment
“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