Innovent Biologics (HKG:1801) said China's National Medical Products Administration approved the second new drug application of Dovbleron to treat adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
The other approved indication is for patients with locally advanced or metastatic ROS1-positive NSCLC previously treated with ROS1 TKI, according to a Friday filing with the Hong Kong bourse.
Dovbleron, or taletrectinib adipate capsule, is a next-generation ROS proto-oncogene 1 (ROS1) tyrosine kinase inhibitor. The Food and Drug Administration granted it Orphan Drug Designation for several NSCLC indications, the filing stated.
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