BMS Reports the US FDA’s Approval of Augtyro (repotrectinib) for the Treatment of Non-Small Cell Lung Cancer (NSCLC)
Shots:
- The approval was based on P-I/II (TRIDENT-1) study evaluating the efficacy, safety, PK, & tolerability of Augtyro in TKI-naïve (n=71) and TKI-pretreated patients (n=56) with advanced solid tumors incl. NSCLC
- The 1EP of the study includes ORR & the 2EPs of the study include DOR, PFS & intracranial response in 6 distinct expansion cohorts incl. TKI-naïve and TKI-pretreated patients with ROS1+ locally advanced/metastatic NSCLC
- The result depicted that of the 79% of TKI-naïve & 38% of TKI-pretreated patients who responded to treatment, 6% & 5% depicted a CR whereas 73% & 32% experienced partial response along with an mDOR of 34.1 & 14.8mos. Moreover, patients with measurable CNS metastases showed responses in 7 of 8 TKI-naïve & 5 of 12 TKI-pretreated patients with intracranial lesions at baseline
Ref: BMS | Image: BMS
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Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.
