US FDA calls for more info on Cell Thera's pixantrone NDA, and firm says it will file for expanded access for NHL patients

Seattle, USA-based Cell Therapeutics revealed this morning that it had received a Complete Response Letter from the Food and Drug Administration regarding its New Drug Application for Pixuvri (pixantrone dimaleate) for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL), which calls for further clinical data.

The FDA cited as its primary reason for the action its concerns previously raised at the Oncologic Drugs Advisory Committee (ODAC) meeting on March 22, and recommended the company conduct an additional trial to demonstrate the safety and effectiveness of its product. Following that news, CT's already battered share price, which had closed at $0.92 on March 21, plunged a further $0.59. US markets had not opened as this story was filed, so today's investor reaction is not available as yet.

Based on the FDA's ODAC presentation, which provided the Committee and the company with alternative options to consider to make investigational drugs available to patients if drugs need to be studied further prior to approval, CT has decided to an pursue expanded access program for pixantrone while it conducts an additional study in aggressive NHL.