BMS Reports EMA’s Validation of Augtyro (repotrectinib) for the Treatment of Solid Tumors

Shots:

• The EMA has validated MAA of Augtyro for treating adults and pediatric patients (12yrs. & older) with ROS1+ and NTRK+ locally advanced or metastatic solid tumors incl. NSCLC
• The application was based on two P-I/II (TRIDENT-1 & CARE) trials assessing the safety, tolerability, PK and anti-tumor activity in adults with ROS1+ NSCLC or NTRK+ solid tumors and pediatric patients (12yrs. & older) with NTRK+ locally advanced/metastatic solid tumors, respectively
• 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 PR 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 in (n=56) patients with intracranial lesions at baseline

Ref: Bristol Myers Squibb | Image: Bristol Myers Squibb | Press Release

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