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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Neuroendocrine Tumor |
| Drug: | Sulanda (surufatinib) (VEGFR inhibitor, FGFR1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
HUTCHMED Announces NMPA Approval of Surufatinib (Sulanda® in China) for Advanced Pancreatic Neuroendocrine Tumors
Published date:
06/18/2021
Excerpt:
HUTCHMED (China) Limited...today announces that surufatinib has been granted approval for drug registration by the National Medical Products Administration of China (“NMPA”) for the treatment of advanced pancreatic neuroendocrine tumors (“pNETs”).
Source:
Title:
Chi-Med Announces the NMPA Approval of Surufatinib (Sulanda® in China) for Non-Pancreatic Neuroendocrine Tumors
Published date:
12/30/2020
Excerpt:
Hutchison China MediTech Limited...today announces that surufatinib has been granted approval for drug registration by the National Medical Products Administration of China (“NMPA”) for the treatment of non-pancreatic neuroendocrine tumors (“NETs”).
Source:
Title:
A pooled analysis of surufatinib safety from phase 3 trials in advanced NETs.
Published date:
05/26/2022
Excerpt:
As of 30th June 2020, 396 patients were assigned to the surufatinib (n = 263) and placebo (n = 133) groups. Median treatment duration was longer with surufatinib 7.4 months (range 0.1–41.4) compared with placebo 4.6 months (range 0.1–39.9). 29% of patients reached more than 12 months of treatment with surufatinib group compared to 11% with placebo...Surufatinib was generally well tolerated in this pooled analysis and the safety profile was consistent with its previously reported data.
DOI:
10.1200/JCO.2022.40.16_suppl.4126
Source:
Title:
Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study
Published date:
09/20/2020
Excerpt:
The median investigator-assessed progression-free survival was 10·9 months (7·5–13·8) for surufatinib versus 3·7 months (2·8–5·6) for placebo (hazard ratio 0·49, 95% CI 0·32–0·76; p=0·0011). The trial met the early stopping criteria at the interim analysis...Surufatinib significantly improves progression-free survival and has an acceptable safety profile in patients with progressive, advanced pancreatic NETs...
DOI:
https://doi.org/10.1016/S1470-2045(20)30493-9
Trial ID:
Source:
Title:
Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study
Published date:
09/20/2020
Excerpt:
Investigator-assessed median progression-free survival was 9·2 months (95% CI 7·4–11·1) in the surufatinib group versus 3·8 months (3·7–5·7) in the placebo group (hazard ratio 0·33; 95% CI 0·22–0·50; p<0·0001)....Progression-free survival was significantly longer in patients given surufatinib compared with patients given placebo, and surufatinib has a favourable benefit-to-risk profile in patients with progressive, advanced, well differentiated extrapancreatic NETs.
DOI:
https://doi.org/10.1016/S1470-2045(20)30496-4
Source:
Title:
Chi-Med Announces Surufatinib Granted U.S. FDA Fast Track Designations for the Treatment of Both Pancreatic and Non-Pancreatic Neuroendocrine Tumors
Published date:
04/17/2020
Excerpt:
Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that the U.S. Food and Drug Administration (“FDA”) has granted two Fast Track Designations for the development of surufatinib, for the treatment of both advanced and progressive pancreatic neuroendocrine tumors (“NET”) and extra-pancreatic (non-pancreatic) NET in patients who are not amenable for surgery.
