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March 31, the cornerstone of Pharmaceutical announced that the Chinese State Drug Administration Bureau (NMPA) has approved its gastrointestinal stromal tumors (GIST) precisely targeted drugs Taj China? (Avatinib tablets) new drug application for the treatment of unresectable or metastatic GIST adult patients with PDGFRA exon 18 mutation (including PDGFRA D842V mutation).
Accurate management of gastrointestinal stromal tumors
Gastrointestinal stromal tumors enter the era of precision treatment
Gastrointestinal stromal tumor (GIST) is a place in the middle of gastric epithelial tissue and muscle relatively rare medsci.
medsci.
The so-called targeted therapy is the use of targeted drugs to block the signal transduction of cancer cells and hinder the growth of cancer cells for the identified carcinogenic sites.
At present, including avatinib, four GIST targeted drugs have been approved for marketing in the United States, and now all have been approved for marketing in China, and Chinese GIST patients can obtain treatment plans that are synchronized with the international ones.
Avatinib meets patients' unmet needs for many years
Before avatinib was approved for marketing, patients with PDGFRA exon 18 D842V mutation were not sensitive to existing targeted drugs, and the curative effect was not satisfactory.
FDA
Tai Jihua? Approved for the treatment of unresectable or metastatic GIST adult patients with PDGFRA exon 18 mutation is based on an open-label, multi-center phase I/II clinical study aimed at evaluating Taijihua? The safety, pharmacokinetic characteristics and anti-tumor efficacy of the treatment of patients with unresectable or metastatic advanced GIST.
Research shows that Tai Jihua? Significant anti-tumor activity was initially shown in Chinese GIST patients with PDGFRA D842V mutation.
Based on the treatment advantages of avatinib , the first edition of "CSCO Gastrointestinal Stromal Tumor Diagnosis and Treatment Guidelines" compiled by the Chinese Society of Clinical Oncology (CSCO) Gastrointestinal Stromal Tumor Expert Committee has recommended the drug for the first-line treatment of PDGFRA D842V mutation and GIST patients after the failure of third-line treatment, this also makes China the first guide-level evidence for the treatment of patients with PDGFRA D842V mutation.
Diagnosis and treatment
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