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Article source: Pharmaceutical Guanlan
According to the latest announcement of the results of the drug registration progress of China's National Food and Drug Administration (NMPA), the new indication for the EGFR-TKI drug icotinib developed by Betta Pharmaceuticals has been applied for The status has been updated to "Under Approval", which means that the new indication is expected to be approved for marketing in the near future.
Image source: Screenshot of NMPA official website
Icotinib is a potent and highly selective oral EGFR-TKI developed by Betta Pharmaceuticals for nearly a decade, and belongs to a category 1 innovative drug.
In 2011, Icotinib was approved for marketing in China for second and third-line treatment of NSCLC patients.
In November 2020, Icotinib was included in the priority review by the NMPA, and its indications are: a single agent for the adjuvant treatment of stage II-IIIA NSCLC with sensitive mutations in the EGFR gene.
It is reported that in a study called EVIDENCE, researchers compared the effects of icotinib and standard adjuvant chemotherapy for postoperative adjuvant treatment of patients with stage II-IIIA lung cancer with EGFR mutations.
If icotinib is approved to assist this new indication after NSCLC surgery, it also means that this drug will exert greater potential in the field of lung cancer treatment.
Note: The original text has been deleted
Reference materials:
[1] Official website of China National Medical Products Administration (NMPA).
