Ascentage Pharma's Novel Drug Olverembatinib Recommended for a Breakthrough Therapy Designation in China for the Treatment of SDH-Deficient GIST, the Second BTD for the Drug
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Wednesday, May 31, 2023
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To date, olverembatinib has been granted two Priority Review Designations that underscored the drug's promising therapeutic utility.
Key Points:
- To date, olverembatinib has been granted two Priority Review Designations that underscored the drug's promising therapeutic utility.
- Drugs that have been granted BTDs are prioritized by the CDE in communications and exchange, and in receiving guidance to advance the drug development progress.
- Furthermore, BTD-designated drugs will be eligible for Priority Review status and conditional approvals upon submission of a New Drug Application (NDA).
- Antitumor activity of olverembatinib (HQP1351) in patients (pts) with tyrosine kinase inhibitor (TKI)–resistant succinate dehydrogenase (SDH)–deficient gastrointestinal stromal tumor (GIST).