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eFT508 Granted Orphan Designation for B-Cell Lymphoma

doi: 10.1097/01.COT.0000515957.68258.44
FDA Updates
FDA; eFT508

FDA; eFT508

The FDA has granted Orphan Drug Designation to eFT508 for the treatment of diffuse large B-cell lymphoma, an aggressive form of non-Hodgkin lymphoma. eFT508 is a potent, highly-selective inhibitor of MNK1 and MNK2, two enzymes critical for the growth and survival of tumors.

The first subject in a phase I/II clinical trial of eFT508 in patients with B-cell hematological malignancies has been dosed. The recently-initiated trial is an open-label, sequential-group, dose-escalation, and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of eFT508. The primary goals will be to establish a maximum tolerated dose and recommended dose for further evaluation and to assess preliminary efficacy of the compound. A phase I/II dose escalation trial of eFT508 in patients with solid tumors is also being conducted.

Wolters Kluwer Health, Inc. All rights reserved.
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