Sunesis announced that the European Commission has granted orphan designation to the company's vosaroxin for the treatment of acute myeloid leukemia. The designation will allow the company market vosaroxin exclusively for 110 years in all EU member countries once the product is approved for the proposed indication.
Vosaroxin has been given orphan drug status and fast
track designation from the US FDA for the same indication.
Vosaroxin is a first-in-class anti-cancer quinolone derivative. It intercalates DNA and inhibits topoisomerase II. This leads to replication-dependent, site-selective DNA damage, G2 arrest and apoptosis.
Vosaroxin is currently being studied in a phase 3, randomized, double-blind, placebo-controlled, pivotal trial evaluating its use in patients with first relapsed or refractory acute myeloid leukemia. The trial plans to enroll approximately 450 patients at approximately 110 leading sites in the US, Canada, Europe, Australia and New Zealand. Patients are randomized into either the placebo group or the vosaroxin group. Patients will receive either placebo or vosaroxin on day one and four in combination with cytarabine that is given daily for 5 days.
Vosaroxin has been given orphan drug status and fast
track designation from the US FDA for the same indication.
Vosaroxin is a first-in-class anti-cancer quinolone derivative. It intercalates DNA and inhibits topoisomerase II. This leads to replication-dependent, site-selective DNA damage, G2 arrest and apoptosis.
Vosaroxin is currently being studied in a phase 3, randomized, double-blind, placebo-controlled, pivotal trial evaluating its use in patients with first relapsed or refractory acute myeloid leukemia. The trial plans to enroll approximately 450 patients at approximately 110 leading sites in the US, Canada, Europe, Australia and New Zealand. Patients are randomized into either the placebo group or the vosaroxin group. Patients will receive either placebo or vosaroxin on day one and four in combination with cytarabine that is given daily for 5 days.
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