Leukemia

This library contains regulatory review documents for several drugs indicated for various forms of leukemia. These include Brukinsa, indicated for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and Waldenström’s macroglobulinemia (WM), which reported a Complete Response (CR) of 59. Imbruvica, for chronic lymphocytic leukemia (CLL) and Waldenström’s macroglobulinemia (WM), showed an Overall response rate (CR+VGPR+PR) per IRRC assessment of 61.9%. Venclexta, for newly diagnosed acute myeloid leukemia (AML), demonstrated an MRD negativity rate in peripheral blood for CR patients (VENCLEXTA + Obinutuzumab) of 87 compared to 62 for Obinutuzumab + Chlorambucil. Sprycel, for Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), achieved a Cumulative Major Cytogenetic Response (MCyR) rate of 98%.

It is important to note that these drugs were studied in different trials, and therefore, the reported figures are not directly comparable head-to-head. Xospata, for relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation, had an Overall Survival Hazard Ratio of 0.64. Trisenox, for acute promyelocytic leukaemia (APL), showed an Event-free survival (EFS) at 3 years (As2O3 arm) of 77 compared to 59 for the standard arm. Dacogen, for acute myeloid leukaemia in adult patients aged 65 years and above, reported a median overall survival increase of 2.7 months.