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Association details:
| Biomarker: | SDHB deletion |
|---|---|
| Cancer: | Gastrointestinal Stromal Tumor |
| Drug: | Nailike (olverembatinib) (Bcr-abl tyrosine kinase inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Innovent Announces the Second Breakthrough Therapy Designation by NMPA for Olverembatinib for the Treatment of Patients with SDH-Deficient GIST
Published date:
06/02/2023
Excerpt:
Innovent Biologics, Inc...announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for olverembatinib for the treatment of patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who had received first-line treatment...Results from an ongoing Phase 1b/2 study of olverembatinib in China showed an impressive clinical benefit rate (CBR) of 93.8% in patients with this subtype of GIST.
Source:
Title:
Antitumor activity of olverembatinib (HQP1351) in patients (pts) with tyrosine kinase inhibitor (TKI)–resistant succinate dehydrogenase (SDH)–deficient gastrointestinal stromal tumor (GIST).
Published date:
05/25/2023
Excerpt:
Olverembatinib was well tolerated up to 50 mg QOD and showed antitumor activity in pts with TKI-resistant, SDH-deficient GIST. A total of 5 PRs were reported among 20 evaluable pts and 15 SDs among 16 pts treated for ≥ 4 cycles (98.3% CBR).
DOI:
10.1200/JCO.2023.41.16_suppl.11540
Trial ID:
