FDA, SciClone meet agreement on distribution of melanoma treatment

NEW YORK The Food and Drug Administration has reached an agreement with a drug maker on the design of a phase 3 trial of a skin cancer drug.

SciClone Pharmaceuticals announced Monday that it had reached the agreement with the agency concerning the drug thymalfasin, which it sees as a potential treatment for stage 4 melanoma.

“Patients suffering from stage 4 melanoma have very few treatment options available,” SciClone chief medical officer Israel Rios said in a statement. “Based on the positive data from an earlier phase 2 trial, thymalfasin could provide new treatment modalities for this high unmet medical need.”

The drug, if approved, will be sold under the brand name Zadaxin. The full name of its active ingredient is thymosin alpha 1.