China-based Ascentage Pharma (HKG: 6855) has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has awarded Breakthrough Therapy Designation (BTD) to its olverembatinib, a novel BCR-ABL1 tyrosine kinase inhibitor (TKI). The designation is for the drug’s use in combination with low-intensity chemotherapy as first-line treatment for newly-diagnosed patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). This marks the third BTD for olverembatinib in China.
Olverembatinib’s Regulatory Milestones
Olverembatinib, the first and only third-generation BCR-ABL TKI in China, received conditional market approval on November 25, 2021, for use in chronic myeloid leukemia (CML) chronic phase (CP) and accelerated phase (AP) with T315I mutation resistant to other TKI treatments. The Category 1 drug, co-commercialized by Innovent Biologics Inc. (HKG: 1801) in China, further expanded its indications in November 2023 with approval for use in adult patients with CML/CP who are resistant and/or intolerant to first and/or second-generation TKIs.
Clinical Significance
The BTD underscores the potential of olverembatinib to address significant unmet needs in hematologic malignancies. By combining olverembatinib with low-intensity chemotherapy, the therapy aims to improve outcomes for newly-diagnosed Ph+ ALL patients, a population with limited treatment options. This designation accelerates the development and potential approval of olverembatinib in this setting, offering hope for patients with aggressive leukemia.-Fineline Info & Tech
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