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On December 8, the latest announcement on the CDE official website showed that Iris vometinib mesylate tablets are planned to be included in the priority review and are intended for use with epidermal growth factor receptor (EGFR) exon 19 deletion mutations (19DEL) or First-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with exon 21 replacement mutation (21L858R)
Screenshot from: CDE official website
Volumetinib mesylate is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) independently developed by Iris, which is a small molecule targeted drug
The phase III clinical study of vomitinib for the first-line treatment of locally advanced or metastatic NSCLC with EGFR-sensitive mutations has recently reached the primary research endpoint.
At present, vometinib has been written into a number of the latest authoritative guidelines, including the "Guidelines for the Clinical Diagnosis and Treatment of Lung Cancer by the Cancer Branch of the Chinese Medical Association (2021 Edition)", "Guidelines for the Treatment of Stage IV Primary Lung Cancer in China (2021 Edition)", and "Lung Cancer Brain transfer of Chinese treatment guidelines (2021 edition) "" CSCO non-small cell lung cancer Guide (2021 edition) "and so on
Prior to this, in order to expand the development and commercialization of vometinib mesylate in overseas markets, Iris signed an overseas exclusive licensing cooperation agreement with ArriVent Biopharma, and reached an overall cooperation on the development and commercialization of vometinib in overseas markets.