BEIJING (dpa-AFX) - Innovent Biologics Inc. announced that China's National Medical Products Administration or NMPA has approved the New Drug Application (NDA) for limertinib as the first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R mutations.
Innovent and ASK Pharm entered into a commercial collaboration agreement for limertinib in Mainland China in 2024.
The company noted that the approval of the new indication is supported by positive results from a randomized, double-blind, positive-controlled Phase 3 clinical trial. A total of 337 treatment-naïve patients with EGFR-sensitive mutation-positive locally advanced or metastatic NSCLC were enrolled and randomized 1:1 to receive either limertinib or gefitinib. The primary endpoint was progression-free survival (PFS), as assed by an independent review committee (IRC).
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