Pharma Focus Asia

Innovent Receives China's National Medical Products Administration Approval for Olverembatinib

Saturday, June 03, 2023

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.

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