Chronic Lymphocytic Leukemia

Leukemia

Patients with early-stage, asymptomatic, newly diagnosed chronic lymphocytic leukemia showed improved survival outcomes with ibrutinib monotherapy compared with placebo, according to results from phase III CLL12 study presented at the 2019 European Hematology Association Congress.<br /> &nbsp;

Combined treatment with ibrutinib and venetoclax was shown to be a safe and effective first-line oral regimen for high-risk and older patients with chronic lymphocytic leukemia, according to findings from an open-label phase II trial published recently in the<em> New England Journal of Medicine</em>.<br /> &nbsp;

Matthew S. Davids, MD, MMSc, discusses the significance of the findings from TRANSCEND CLL 004, a phase I/II trial investigating the CAR T-cell therapy lisocabtagene maraleucel in patients with relapsed or refractory chronic lymphocytic leukemia.

Patients with chronic lymphocytic leukemia showed high responses when given a combination of acalabrutinib and obinutuzumab, which targets BTK and the CD20 antigen. High response rates over 90% were seen across various settings of disease, according to the results of a small, preliminary trial.

According to the pivotal phase III CLL14 study presented during the 2019 American Society of Clinical Oncology Annual Meeting, venetoclax plus obinutuzumab demonstrated a lengthening in progression-free survival time for patients with previously untreated chronic lymphocytic leukemia compared with obinutuzumab plus chlorambucil. Trial results show that the chemotherapy-free combination reduced the risk for disease worsening or death by 65% compared with obinutuzumab plus chlorambucil.

A look back at all the&nbsp;FDA news&nbsp;that happened in the month of&nbsp;May 2019, including several new approvals, orphan drug designations, breakthrough therapy designations, fast track designations, and more.