Innovent and AnHeart’s Receive NMPA’s Breakthrough Therapy Designation for Taletrectinib to Treat ROS1-Positive Non-Small Cell Lung Cancer
Shots:
- The NMPA has granted BTD to taletrectinib for TKI-naïve & pretreated patients with ROS1+ NSCLC
- The designation was based on the P-II (TRUST) trial of taletrectinib in patients with ROS1 fusion+ NSCLC. At the data cut-off date June 16, 2021, the results showed 90.5% (19/21) ORR & DCR {90.5% (19/21)} in treatment-naïve patient while ORR {43.8% (7/16)}; DCR {75.0% (12/16)} in the pre-treated patient
- The therapy showed promising efficacy in patients with resistant G2032R mutation, intracranial antitumor activity in brain metastatic patients with neurological AEs & was well-tolerated. Taletrectinib is a ROS1 inhibitor & is designed to target ROS1 fusion mutations for both patients
Ref: PR Newswire | Image: Fierce Pharma
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