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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. 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. Small lymphocytic lymphoma represents a clinical variant of CLL and is similarly managed.

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.

In a presentation during the 2018 SOHO Annual Meeting, Terry J. Fry, MD, discussed some of the data that have been seen so far with CD19- and CD22-direct CAR T cells, and addressed resistance to these products. &nbsp;