The FDA grants eFT508 Orphan Drug Designation for DLBCL

Last week, on 10th March 2017, eFT508 was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of DLBCL.

eFFECTOR Therapeutics’ eFT508 is a novel, highly selective, oral, small molecule inhibitor of MAP Kinase-Interacting Kinase 1 and 2 (MNK1/2). eFT508 activates anti-tumor immunity and also blocks several oncogenic growth and proliferation pathways.

The inhibitor is currently being assessed in patients with previously treated hematological malignancies in a phase I/II dose-escalation and cohort-expansion study (NCT02937675). Primary outcome measures are to determine the Maximum Tolerated Dose (MTD) and Overall Response Rate (ORR). The estimated primary completion date is October 2018.

A similar phase I/II trial (NCT02605083) of eFT508 is also being conducted in advanced solid tumor malignancies which have progressed after prior therapy and have no potential for cure with other therapy.

  1. FDA grants orphan drug designation to eFT508 for DLBCL. 2017 Mar 10. http://www.healio.com/hematology-oncology/lymphoma/news/online/%7B10c4a3cd-2303-4124-9765-ac0205b50444%7D/fda-grants-orphan-drug-designation-to-eft508-for-dlbcl. [Accessed 2017 Mar 13].