In effect to the FDA’s complete response letter, the company has decided to pursue expanded access program for pixantrone while conducting an additional study in aggressive NHL.
The FDA had earlier raised it concerns at the Oncologic Drugs Advisory Committee (ODAC) meeting on March 22, 2010, over the usage of Pixuvri for NHL treatment. It further 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.
Cell Therapeutics plans to request a meeting with the FDA on both the design of the follow-on study as well as expanded access program for patients who are not participating in the company’s clinical trial.
In preparation to submit its marketing authorization application (MAA) to the European Medicines Agency (EMEA) for review, Cell Therapeutics will meet its clinical expert and the co-rapporteurs later this month, and expects to submit the application in the third quarter of 2010 based on EMEA feedback.