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Nuvalent’s NVL-655 Granted Breakthrough Therapy Designation by FDA

Will advance NVL-655 in recognition of the continued need for innovation for patients with ALK-positive NSCLC who have exhausted available therapies.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to Nuvalent Inc.’s NVL-655 for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with two or more ALK tyrosine kinase inhibitors (TKIs).   NVL-655 is a novel brain-penetrant ALK-selective TKI created with the aim to simultaneously overcome the clinical challenges of emergent treatment resistance, brain metast...

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