Chronic Lymphocytic Leukemia

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According to a retrospective phase I/II study, over 80% of patients with relapsed or refractory chronic lymphocytic leukemia responded to concurrent treatment with ibrutinib and the CD19-targeted chimeric antigen receptor CAR T-cell therapy, JCAR014.<sup>1</sup> Findings from this study were presented at&nbsp;the 60th American Society of Hematology Annual Meeting.

CLL is a malignant disease characterized by progressive accumulation of immature, immunophenotypically distinct lymphocytes in the blood, bone marrow, and lymphatic tissues. Although the clinical course of CLL can be unpredictable, this disease is typically slow-progressing and occurs most often in patients &ge;65 years of age.&nbsp;As such, treatment, if indicated, is typically conservative.&nbsp;Current CLL treatments are not considered to be curative; however, long-term remission can be achieved in some patients using allogenic stem cell transplantation.

Chronic lymphocytic leukemia is characterized by the clonal proliferation and accumulation of small, mature-appearing CD5-positive B lymphocytes in the blood, bone marrow, and secondary lymphoid tissues.&nbsp;A CLL diagnosis is established by the presence of more than 5x109/L peripheral lymphocytes co-expressing CD5, CD19, and CD23, and weakly expressing CD20, CD79b, and surface immunoglobulin.&nbsp;Small lymphocytic lymphoma represents a clinical variant of CLL and is similarly managed.

Richard Furman, MD, discusses how survival times for patients with chronic lymphocytic leukemia have increased dramatically in the past decade, thanks to an ever-expanding armamentarium of novel agents and more patients now being diagnosed earlier.

A look back at all the&nbsp;FDA news&nbsp;that happened in the month of&nbsp;October 2018, including several new FDA approvals, priority reviews, a breakthrough therapy designation, and more, in a variety of cancer types.<br /> &nbsp;

Duvelisib (Copiktra) has been approved by the FDA for the&nbsp;treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or relapsed/refractory follicular lymphoma.&nbsp;Both indications are for the treatment of patients who have received at least 2 prior therapies.

Based on data from the phase III MURANO trial, the European Medicines Agency&rsquo;s Committee for Medicinal Products for Human Use has recommended the approval of venetoclax&nbsp;for patients with chronic lymphocytic leukemia who have received at least 1 previous therapy. AbbVie, a co-developer of venetoclax with Roche, announced the CHMP&rsquo;s decision in a news release.