LEUKEMIAS

<em>FLT3</em> mutation analysis in laboratories has brought on reimbursement barriers in clinical oncology. Jordan Clark, chief commercial officer, Diaceutics, a diagnostic development and commercialization company, spoke to <em>Targeted Oncology</em> about the cause of reimbursement issues and how the problem affects all parties involved.

At 3 years of follow-up, the combination of acalabrutinib and obinutuzumab continued to show benefit in patients with both newly diagnosed chronic lymphocytic leukemia and relapsed or refractory disease.

Addressing the need for treatments that are more effective and less toxic for patients with relapsed or refractory chronic lymphocytic leukemia, Paolo Ghia, MD, of the Universita Vita-Salute San Raffaele, and other researchers conducted a phase III randomized, multicentric ASCEND study, testing acalabrutinib monotherapy in comparison with physician&rsquo;s choice of standard regimens in patients R/R CLL.

Significant activity was observed when ibrutinib was administered concurrently with CD19-directed CAR T-cell therapy compared with separately in patients with&nbsp;high-risk relapsed/refractory chronic lymphocytic leukemia who had progressed on or were intolerant of ibrutinib.&nbsp;Data presented at the 15th International Conference on Malignant Lymphoma show a high response rate with this concurrent treatment.&nbsp;

A complete response letter has been issued to&nbsp;Daiichi Sankyo from the FDA, alerting the company to the reasons why the new drug application for quizartinib as a&nbsp;treatment of adult patients with relapsed/refractory&nbsp;<em>FLT3</em>-ITD&ndash;positive acute myeloid leukemia would not be approved.&nbsp;

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;

In an interview with <em>Targeted Oncology</em>, Naval G. Daver, MD, discussed the possibility of combination therapy in patients with AML. He highlights some of the most recent data to come out for this patient population, including for those harboring a <em>TP53</em> or <em>FLT3</em> mutation.

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.