The designation has been given to Marqibo for the treatment of Philadelphia chromosome negative acute lymphoblastic leukemia (ALL) in second relapse or who have failed two lines of prior therapy. Earlier this year, Marqibo was also granted orphan drug designation by the FDA for the treatment of adult ALL.
According to the FDA, Marqibo is eligible for Fast Track designation because there is an unmet medical need in adult patients with Philadelphia chromosome negative ALL who have relapsed twice or who have failed two lines of anti-leukemia chemotherapy, including those who have undergone stem cell transplantation.
Hana’s Phase II clinical trial is a multi-center, multi-national trial evaluating Marqibo in this patient population. The primary objective of the study is to assess the efficacy and tolerability of weekly doses of Marqibo as a single agent without dose capping, measured by complete response (CR) rate or complete response without full platelet recovery (CRp). Secondary objectives include evaluation of safety, duration of CR/CRp, and survival. Hana expects to enroll up to 56 patients in the study.