Innovent Biologics Inc., (HKG: 1801), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China has accepted a second New Drug Application (NDA) for its investigational drug taletrectinib. This next-generation tyrosine kinase inhibitor (TKI) targets ROS1 and NTRK fusion mutations and is currently under review for approval as a first-line treatment for patients with advanced or metastatic ROS1 positive non-small cell lung cancer (NSCLC) who have not been previously treated with a ROS1 TKI.
In November 2023, the first NDA for taletrectinib was accepted with priority review status for the treatment of locally advanced or metastatic ROS1 positive NSCLC in patients who had been previously treated with a ROS1 TKI. Both NDAs are supported by positive results from the Phase II TRUST-I study, which demonstrated the drug’s potential for best-in-class efficacy and safety.- Flcube.com
