Published on October 31, 2009 at 3:09 AM
Schering-Plough Corp. (NYSE: SGP) announced today the U.S. Food and Drug Administration (FDA) has issued a complete response letter to the company's supplemental Biologics License Application regarding PEGINTRON® (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete lymphadenectomy.
Schering-Plough will work closely with FDA to respond to outstanding concerns related to the PEGINTRON melanoma filing.
In early October, the FDA's Oncologic Drugs Advisory Committee recommended approval of PEGINTRON in this indication by a vote of 6 to 4. Schering-Plough had sought approval for this indication based on data from the largest positive adjuvant trial in subjects with stage III melanoma.
Introducing new drugs to treat malignant melanoma remains a challenge, and Schering-Plough is committed to the treatment of this aggressive form of cancer.
SOURCE Schering-Plough Corporation
c3fa1d4f-06bd-4b30-80ad-b27272ea5cd9|0|.0
Posted in: Drug Trial News | Medical Condition News
Tags: Anemia, Angina, Angioedema, Anorexia, Anxiety, Arthritis, Blindness, Bone, Bone Marrow, Cancer, Cardiomyopathy, Cell, Cellulitis, Cirrhosis, Contraception, Creatinine, Depression, Dyspnea, Edema, Emphysema, Fibrosis, Gastroenteritis, Gout, Headache, Hepatitis C, Hyperglycemia, Hypersensitivity, Hyperthyroidism, Hypertriglyceridemia, Hypothyroidism, Insomnia, Lupus, Melanoma, Nausea, Neuropathy, Neutropenia, Oncology, Pancreatitis, Pneumonia, Pregnancy, Psoriasis, Psychosis, Pulmonary Hypertension, Rheumatoid Arthritis, Ribavirin, Sarcoidosis, Sepsis, Thalassemia, Thrombocytopenia, Thrombosis, Transient Ischemic Attack, Urticaria, Vasculitis, Vomiting, Weight Loss