(Reuters) -The U.S. Food and Drug Administration on Wednesday cleared Regeneron Pharmaceuticals’ immunotherapy, Libtayo, as an add-on treatment for skin cancer patients at high risk of their disease returning after surgery and radiation, the drugmaker said.

Libtayo is already approved in the U.S. for advanced skin cancer, basal cell carcinoma, advanced non-small cell lung cancer and cervical cancer.

Regeneron said its approved application did not include contract drugmaker Catalent’s Indiana facility as a fill-finish site for the drug. The FDA in August had declined to approve Regeneron’s blood cancer therapy, odronextamab, citing its inspection of the facility.

The Bloomington, Indiana site handles the final stages of drug preparation and packaging for Regeneron’s Eylea HD and odronext

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