Nuvalent Granted FDA Breakthrough Therapy Designation for Non–Small Cell Lung Cancer Drug

Pharmaceutical Executive February 28, 2024
Davy James

NVL-520 is a novel, brain-penetrant, ROS1-selective tyrosine kinase inhibitor under evaluation for patients with metastatic ROS1-positive non–small cell lung cancer.

Nuvalent, Inc’s novel, brain-penetrant, ROS1-selective tyrosine kinase inhibitor (TKI) NVL-520 has been granted Breakthrough Therapy Designation by the FDA to treat patients with metastatic ROS1-positive non–small cell lung cancer (NSCLC) who received prior therapy with at least two ROS1 TKIs.¹ NVL-520 was developed with the intention of addressing treatment challenges that limit the use of current ROS1 TKIs, including treatment resistance, brain metastases, and off-target central nervous system (CNS) adverse events (AEs) that have been linked to inhibiting the structurally-related tropomyosin receptor kinase family.¹

“In line with our commitment to bringing new potential best-in-class medicines to patients with cancer as...

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