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Article source: Medical Rubik's Cube Info
On June 3, the official website of the State Food and Drug Administration showed that the application for the new indications of Betta Pharmaceuticals Icotinib Tablets (acceptance number: CXHS2000030) has been approved by the NMPA
.
For postoperative adjuvant treatment of non-small cell lung cancer (NSCLC) patients with sensitive mutations in the epidermal growth factor receptor (EGFR) gene
Icotinib is China’s first small-molecule targeted anti-cancer drug with independent intellectual property rights independently developed by Betta Pharmaceuticals.
Two indications have been approved before: ① Single-agent first-line treatment of sensitive EGFR gene mutations Patients with advanced or metastatic NSCLC; ②Patients with locally advanced or metastatic NSCLC who have previously received at least one platinum-based combination chemotherapy regimen after failure of single-agent therapy
.
The study code-named EVIDENCE evaluated the safety and efficacy of icotinib vs.
standard adjuvant chemotherapy for postoperative adjuvant treatment of patients with stage II-IIIA lung cancer with EGFR mutations
.
The results of the nearly 6-year study show that icotinib is more effective than standard adjuvant chemotherapy, can significantly prolong the disease-free survival of patients, and has better safety
Note: The original text has been deleted
