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