The European Medicines Agency (EMA) has accepted for review a filing submitted by Bristol Myers Squibb (BMS; NYSE: BMY) for its orphan drug, Augtyro (repotrectinib), which targets ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and NTRK-positive locally advanced or metastatic solid tumors. The next-generation tyrosine kinase inhibitor (TKI) has been highlighted by the company as a potential best-in-class treatment for the first indication, having received approval in the US last year.
The submission is supported by interim Phase I/II data that demonstrate a robust duration of response (DOR) and intracranial responses in both types of cancer, including tumors with resistance mutations. This marks a significant step in the global regulatory process for Augtyro, which BMS acquired in 2022 when it purchased Turning Point Therapeutics, the original developer, for USD 4.1 billion.- Flcube.com
