Chiron Proleukin metastatic melanoma lower-dose postmarketing studies urged by FDA advisory cmte..

Executive Summary

CHIRON PROLEUKIN LOWER DOSE STUDIES IN METASTATIC MELANOMA should be conducted post-approval, with the agent alone or in combination with interferon alfa or chemotherapeutic drugs, FDA's Oncologic Drugs Advisory Committee suggested Dec. 19. Reduced Proleukin (aldesleukin, interleukin-2) doses could decrease toxicity and lower the cost of treatment, committee member Derek Raghavan, MD/PhD, Roswell Park Cancer Institute, maintained. BLA 97-0501 was accepted for priority review by FDA April 10. Proleukin has been approved since 1992 for renal cell carcinoma.