Innovent Biologics announced that the Centre for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has awarded Breakthrough Therapy Designation (BTD) for olverembatinib.
This designation recognises it as a potential promising treatment for patients diagnosed with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumour (GIST) who have undergone first-line therapy.
Olverembatinib is a novel third-generation BCR-ABL inhibitor that has received approval in China for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic-phase chronic myeloid leukaemia (CML-CP) or accelerated-phase CML (CML-AP) that harbour the T315I mutation.
Olverembatinib, an orally active third-generation BCR-ABL inhibitor has shown efficacy in targeting a range of BCR-ABL mutants, including the challenging T315I mutation commonly encountered in CML. By offering a therapeutic option for patients with these resistant forms of CML, olverembatinib represents a significant advancement in the field of leukaemia treatment.
