Regeneron Gets FDA Priority Review of Libtayo in Lung Cancer

By Colin Kellaher

Regeneron Pharmaceuticals Inc. on Thursday said the U.S. Food and Drug Administration granted priority review to its application for expanded use of Libtayo in a form of lung cancer.

The Tarrytown, N.Y., biotechnology company said the application covers the treatment of patients with first-line locally advanced or metastatic non-small-cell lung cancer with programmed death-ligand 1, or PD-L1, expression of 50% or greater.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period. Regeneron said the agency set a target action date of Feb. 28, 2021, for the application.

Regeneron said the European Medicines Agency is also assessing Libtayo in the indication, with a decision expected in the second quarter of 2021.

Libtayo, which Regeneron is jointly developing and commercializing with France's Sanofi SA, is approved in the U.S. and European Union for adults with cutaneous squamous-cell carcinoma.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

October 29, 2020 07:55 ET (11:55 GMT)

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