Olverembatinib Receives Breakthrough Therapy Designation for Treating Philadelphia Chromosome-Positive (Ph+) ALL
Olverembatinib has been granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA) through the Centre for Drug Evaluation (CDE).
This designation supports its use in combination with low-intensity chemotherapy as a first-line treatment for newly diagnosed patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
This marks the third BTD awarded to olverembatinib in China. The first, in March 2021, was for treating patients with chronic-phase chronic myeloid leukemia (CML-CP) who did not respond to or could not tolerate first- and second-generation tyrosine kinase inhibitors (TKIs).
The second was granted in June 2023 for patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumors (GIST) following first-line treatment.
BTD is reserved for innovative or modified drugs targeting severe or life-threatening conditions, particularly when no existing treatments are available or when strong evidence suggests significant benefits over current options.
This designation ensures priority regulatory support, facilitating a faster development process. Under certain conditions, drugs with BTD status may also qualify for Priority Review and conditional approval upon submission of a New Drug Application (NDA) in China.
Olverembatinib is China’s first approved third-generation BCR-ABL inhibitor and is co-commercialized by Ascentage Pharma and Innovent Biologics.
It has been authorized for the treatment of adult patients with TKI-resistant CML-CP or accelerated-phase CML (CML-AP) carrying the T315I mutation, as well as CML-CP patients who cannot tolerate or do not respond to first- and second-generation TKIs. All approved indications have been included in the China National Reimbursement Drug List (NRDL).
The latest BTD underscores olverembatinib’s potential in addressing a significant unmet medical need. Continued clinical development efforts aim to bring this treatment to patients as quickly as possible.
