We are focusing on obtaining pixantrone approval based on the EXTEND (PIX301) phase III clinical trial of pixantrone for patients with relapsed or refractory aggressive NHL. Enrollment is complete in this trial, and we have announced that it achieved the primary efficacy endpoint based on a preliminary intent-to-treat efficacy analysis.
The U.S. Food and Drug Administration (FDA) accepted for standard review our New Drug Application (NDA) with a Prescription Drug User Fee Act (PDUFA) action date of April 23, 2010.
Pixantrone has fast track status and its proposed indication is for the single-agent treatment of patients with relapsed or refractory aggressive NHL who have received two or more prior lines of therapy.
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