Nuvalent Inc (Nasdaq: NUVL), a US-based clinical-stage biopharmaceutical company, announced on Tuesday that it has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for its NVL-520 intended for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with two or more ROS1 tyrosine kinase inhibitors (TKIs).

NVL-520 is a novel brain-penetrant ROS1-selective tyrosine kinase inhibitor (TKI) created with the aim to simultaneously overcome the clinical challenges of emergent treatment resistance, brain metastases, and off-target central nervous system (CNS) adverse events associated with inhibition of the structurally-related tropomyosin receptor kinase (TRK) family that may limit the use of currently available ROS1 TKIs.

NVL-520 received BTD based on the preliminary safety and activity of NVL-520 in heavily pretreated patients with advanced ROS1-positive NSCLC in the Phase 1 portion of the Phase 1/2 ARROS-1 clinical trial. Enrolment in the Phase 2 portion of the trial is ongoing, and the company expects to share updated data from the trial at a medical meeting in 2024.