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Betta Pharmaceuticals' new indication of "Icotinib Tablets" is approved for postoperative adjuvant treatment of NSCLC

 Last Update: 2021-06-18
 Source: Internet
 Author: User

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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

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