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Gregory J. Riely, MD, PhD


FDA Brief: Breakthrough Therapy Designation Granted to Two Tyrosine Kinase Inhibitors in NSCLC

By: JNCCN 360 Staff
Posted: Wednesday, February 28, 2024

This week, two investigational tyrosine kinase inhibitors in the treatment of non–small cell lung cancer (NSCLC) have been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA): Nuvalent’s ROS1-selected NVL-520 and Bayer’s HER2-mutated and EGFR-mutated BAY 2927088.

The decision for NVL-520 is based on the safety and efficacy data from the phase I portion of the ARROS-1 clinical trial ( identifier NCT05118789), which is evaluating its use in heavily pretreated patients with advanced ROS1-positive NSCLC. Enrollment for the phase II portion of the trial is ongoing, with data expected to be presented later in 2024. This brain-penetrant agent has been designed to address the challenges of treatment resistance, brain metastases, and off-target central nervous system adverse events.

The decision for BAY 2927088 is based on the preliminary clinical evidence from a phase I, open-label, multicenter, first-in-human study (NCT05099172). This trial is evaluating the safety, pharmacokinetics, and preliminary efficacy of BAY 2927088 in adults with unresectable or metastatic NSCLC harboring HER2 or EGFR.

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