The NMPA Accepts Anheart Therapeutics & Innovent’s NDA for Taletrectinib and Grants Priority Review for the Treatment of Non-Small Cell Lung Cancer
Shots:
- The NMPA granted Priority Review based on the data from the P-II (TRUST-I) trial evaluating taletrectinib (600mg, QD) in 2 cohorts of ROS1 TKI-naïve & crizotinib-pretreated patients (n=109) with NSCLC. The 1EP of the study include IRC-assessed cORR & 2EPs include DoR, DCR, IC-ORR, PFS, TTR & OS
- The results depicted a cORR of 92.5% & 52.6%, DCR of 95.5% & 81.6%, mTTR of 1.4mos. (in both cohorts), mPFS not responsive in 1st cohort & 9.8mos. in the 2nd & mDoR not responsive in both the cohorts
- Taletrectinib is an ROS1 (TKI) being evaluated in a P-II (TRUST-I) in China & (TRUST-II) globally. Earlier in Mar 2022, Taletrectinib received BTD by the NMPA for advanced or metastatic ROS1-positive NSCLC
Ref: Anheart Therapeutics | Image: Anheart Therapeutics
Related News:- Guardant Health Collaborated with AnHeart Therapeutics to Develop Guardant360 CDx and Guardant360 TissueNext for Taletrectinib
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
