Danziten (nilotinib) / Azurity Pharma - LARVOL DELTA

Nilotinib versus imatinib with early switch from imatinib to nilotinib to obtain treatment-free remission in newly diagnosed chronic myeloid leukemia patients: the analysis of the first co-primary endpoint (Nature) - "Of the 448 enrolled patients, 228 and 220 were randomized to the nilotinib (NIL) and imatinib (IM) arms, respectively, and followed for a median of 45.9 months. Eighty-two (37.2%) of the 220 patients on the IMarm did not fulfill the ELN criteria for optimal response of treatment and switched to nilotinib therapy. At the 24 months of follow-up, 107 of the 448 patients reached an MR4.5 response with a significantly higher frequency within the patients on the nilotinib arm (65 vs 42; p = 0.02). The analysis of the first primary endpoint indicates that, despite the early switch in the IM-randomized patients, NIL therapy is more effective to induce DMR."

P4 data • Chronic Myeloid Leukemia

AZURITY PHARMACEUTICALS, INC ANNOUNCES FDA APPROVAL OF DANZITEN (nilotinib) tablets, THE FIRST AND ONLY NILOTINIB WITH NO MEALTIME RESTRICTIONS (PRNewswire) - "Azurity Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has approved Danziten, the first and only nilotinib with no mealtime restrictions indicated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and adult patients with chronic phase (CP) and acute phase (AP) resistant or intolerant to prior therapy that included imatinib....Danziten is a re-engineered formulation of nilotinib without mealtime restrictions that offers equivalent efficacy to Tasigna but with improved bioavailability, allowing for a lower dose."

Evidence highlight • FDA approval • Chronic Myeloid Leukemia • ABL1 • BCR