On January 2, according to the National Drug Administration website, AstraZeneca (AZN.US)'s application for marketing a new indication of osidinib was officially approved.
The Zhitong Finance App learned that on January 2, the China Drug Administration website showed that AstraZeneca (AZN.US)'s application for marketing a new indication of ositinib was officially approved to treat adult patients with locally advanced unresectable (stage III) non-small cell lung cancer (NSCLC) without disease progression after receiving platinum-containing radical chemoradiotherapy, and who have epidermal growth factor receptor (EGFR) exon 19 deficiency (EX19DEL) or exon 21 (L858R) replacement mutations.
According to reports, osimitinib is an irreversible third-representative dermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), which has clinical activity against CNS metastasis. The product has been approved in China for 4 indications, namely: 1) adult patients with locally advanced or metastatic NSCLC who have progressed during or after EGFR TKI treatment and tests confirm positive EGFR T790M mutations; 2) first-line treatment of NSCLC patients with EX19DEL or L858R replacement mutations; 3) adjuvant treatment of patients with EGFR-sensitive mutation NSCLC adult tumors after tumor resection; 4) first-line treatment with pemetrexed and platinum chemotherapy drugs or exon 21 ( L858R) Adult patients with locally advanced or metastatic NSCLC with replacement mutations.