Oct 8 (Reuters) - The U.S. Food and Drug Administration

on Wednesday cleared Regeneron Pharmaceuticals' ( REGN )

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

odronextamab. The contract drugmaker was acquired by Novo

Nordisk last year.

Following an inspection at the facility in June and July,

the FDA issued six observations detailing a range of

manufacturing lapses, including the improper investigation of

contaminants - one of which was identified as cat hair.

Regeneron said in August it is working with regulators to

resolve manufacturing issues at the site, which has delayed

other drug approvals including Scholar Rock's ( SRRK ) muscle

weakness therapy.

Libtayo was cleared Wednesday as an adjuvant treatment for

adult patients with cutaneous squamous cell carcinoma (CSCC) -

the second-most common form of skin cancer.

The approval is based on a late-stage trial with 415

patients, in which Libtayo reduced the risk of cancer recurrence

or death by 68% compared with placebo.