BMS’ Augtyro (Repotrectinib) Gains the CHMP’s Positive Opinion to Treat Advanced ROS1+ NSCLC and NTRK+ Solid Tumors

Shots: The CHMP has granted positive opinion to repotrectinib for treating ROS1+ advanced NSCLC in adults and NTRK+ advanced solid tumors in patients (≥12yrs.), with the EC’s decision anticipated in Jan 2025 Opinion was based on P-I/II (TRIDENT-1 & CARE) trials, with TRIDENT-1 assessing repotrectinib in advanced solid tumors (NSCLC and tumors with ROS1 &…

ByDipanshu DixitNovember 15, 2024

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+…

ByDipanshu DixitJanuary 2, 2024

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available…

BySenior EditorMarch 11, 2021

BMS’ Augtyro (Repotrectinib) Gains the CHMP’s Positive Opinion to Treat Advanced ROS1+ NSCLC and NTRK+ Solid Tumors

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

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

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