“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.”
