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

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


  • 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 (n=71) & 5 of 12 TKI-pretreated in (n=56) patients with intracranial lesions at baseline

Ref: BMS | Image: BMS

Related News:- BMS Reports the Acceptance of its sBLA for Opdivo Combination Therapy by the US FDA and EMA for the Treatment of Non-Small Cell Lung Cancer (NSCLC)

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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