Chronic Myeloid Leukemia

According to results presented at the 2018 ASCO Annual Meeting, moxetumomab pasudotox, a first-in-class recombinant immunotoxin targeting CD22, demonstrated deep and durable responses in a substantial proportion of pretreated patients with relapsed/refractory hairy cell leukemia.

The FDA approved several indications throughout the month of April 2018. A number of drugs were granted priority review and Fast Track designation. The FDA also halted all clinical trials using tazemetostat as treatment, and new initiatives were introduced to help ease the development of genetic and genomic-based tests. Check out our list of all FDA happenings from April 2018.

Based on data from 2 clinical trials, nilotinib (Tasigna) has been approved by the FDA for the first- and second-line treatment of pediatric patients aged 1 year and older with Philadelphia chromosome–positive chronic myeloid leukemia in the chronic phase. 

The Therapeutic Approach for Relapsed CML

Arsenic trioxide (Trisenox) has been approved by the FDA in&nbsp;combination with the all-trans retinoic acid agent tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia with the t(15;17) translocation or <em>PML-RARA</em> gene expression.