On March 5, 2025, Ascentage Pharma announced that its drug, olverembatinib, received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA). This designation is for olverembatinib in combination with low-intensity chemotherapy for the first-line treatment of newly-diagnosed patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
This marks the third BTD granted to olverembatinib in China, highlighting its therapeutic potential in hematologic malignancies. BTD status prioritizes communication and guidance from the NMPA, accelerating drug development.
Drugs with BTD are eligible for Priority Review and conditional approvals upon New Drug Application (NDA) submission, which can significantly expedite market access. This designation addresses a substantial unmet medical need in Ph+ ALL, where no TKI has yet been approved for first-line treatment in China.
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