Update on drug against non-Hodgkin’s lymphoma (NHL) in final development stage
Cell Therapeutics is a biotech company dev eloping a drug against refractory non-
Hodgkin’s lymphoma (NHL), and is in the final stage of development. Pixantrone is a novel anthracycline-like drug with unique structural and physio-chemical properties that may allow the anti-cancer potency of these class of drugs in the treatment of relapsed/refractory aggressive lymphoma without unacceptable rates of cardiotoxicity.
Last month, the European Medicines Agency (EMA) agreed to review a Marketing Authorization Application (the “MAA”) . The path is a bit more rocky with the FDA, which requested an additional clinical trial of Pixuvri. The company expects a response on an appeal next quarter, saying it believed Pixuvri had met the requirements for accelerated approval. Either way, the company Cell Therapeutics plans to start an additional U.S. clinical trial and use the results for approval or as a post-approval confirmatory study of Pixuvri activity.