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Innovent’s Olverembatinib Receives the NMPA’s Breakthrough Therapy Designation for Succinate Dehydrogenase-Deficient Gastrointestinal Stromal Tumor

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Innovent’s Olverembatinib Receives the NMPA’s Breakthrough Therapy Designation for Succinate Dehydrogenase-Deficient Gastrointestinal Stromal Tumor

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  • The NMPA has granted BTD for olverembatinib to treat patients with succinate dehydrogenase (SDH)-deficient GIST who had received first-line treatment. Olverembatinib is jointly commercialized in China by Ascentage Pharma and Innovent Biologics
  • The P-Ib/II study results of olverembatinib showed an impressive CBR of 93.8% in patients with this subtype of GIST. The results were presentations at ASCO for two consecutive years
  • Olverembatinib, the first third-generation BCR-ABL inhibitor approved in China for TKI-resistant CML-CP or CML-AP harboring the T315I mutation. The therapy has received 1 FTD & 4 ODDs from the US FDA for CML, ALL, AML, and GIST; and 1 Orphan Designation from the EMA for CML

Ref: PRNewswire | Image: Innovent

Related News:- Innovent and Ascentage Report NMPA Acceptance of NDA and Granted Priority Review Designation for Olverembatinib to Treat Chronic Myeloid Leukemia

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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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