Nuvalent Gets FDA Breakthrough Therapy Designation for Lung-Cancer Treatment
By Paul Ziobro
Nuvalent said federal regulators have granted breakthrough therapy designation for NVL-655 to treat patients with a certain type of lung cancer.
The clinical-stage biopharmaceutical company on Thursday said that the Food and Drug Administration granted the status 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, or TKIs.
The company said there remains no clear standard of care for patients who have been previously been treated with two or more ALK TKIs.
The breakthrough therapy designation is designed by the FDA to expedite the development and evaluation of treatments for serious or life-threatening conditions if they have preliminary clinical evidence showing substantial improvement at certain endpoints over currently available therapies.
Write to Paul Ziobro at paul.ziobro@wsj.com
(END) Dow Jones Newswires
May 16, 2024 16:31 ET (20:31 GMT)
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