16 May 2024 - Nuvalent today announced that the US FDA has granted breakthrough therapy designation to NVL-655 for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer who have been previously treated with two or more ALK tyrosine kinase inhibitors.

The breakthrough therapy designation for NVL-655 is based on the preliminary safety and activity of NVL-655 in heavily pretreated patients with advanced ALK-positive non-small cell lung cancer in the Phase 1 portion of the Phase 1/2 ALKOVE-1 clinical trial.

Read Nuvalent press release