FDA Updates

Published: Friday, May 14, 2010
The FDA gave ImmunoGen’s IMGN901 an orphan drug designation as a treatment for Merkel cell carcinoma. Merkel is a rare aggressive cancer that develops subcutaneously, generally in the head or neck. IMGN901 is currently in an early stage clinical trial.




The FDA will fast track its evaluation of zalutumumab, a novel human antibody developed by Genmab for refractory squamous cell carcinoma of the head and neck. Zalutumumab targets the epidermal growth factor receptor, and early data from a phase III trial showed it improved overall survival (OS) and progressionfree survival compared with best supportive care. The improvement in OS was not statistically significant, however, and failed to meet the trial’s primary endpoint.




The FDA has warned the manufacturer of POM pomegranate juice to stop implying on its Website that its juice prevents or helps treat cancer and other serious health conditions. The FDA said the claims are misleading and would be permitted only if the juice were regulated as a drug.




The FDA has rescheduled the ODAC meeting for pixantrone to March 22. The FDA is considering a New Drug Application for pixantrone as a treatment for relapsed/ refractory aggressive non-Hodgkin lymphoma and plans to make a final decision by April 23.




The FDA granted orphan drug designation to Ariad’s AP24534, which is being investigated as a treatment for chronic myeloid leukemia and Philadelphia chromosome– positive acute lymphoblastic leukemia. Ariad plans to conduct a registration trial later this year.




Adventrx Pharmaceuticals received a Refuse to File letter from the FDA for its New Drug Application for ANX-530, an injectable formulation of vinorelbine. The FDA said the data from the proposed manufacturing site was insufficient. Adventrx hopes to meet with the FDA to discuss the application.







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