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FDA Brief: BCMA-Targeting Immunotherapy Receives Fast Track Designation in Myeloma

By: Lauren Velentzas
Posted: Thursday, March 17, 2022

Harpoon Therapeutics recently announced that the U.S. Food and Drug Administration has granted Fast Track designation to HPN217, a B-cell maturation antigen–targeting, trispecific T-cell–activating construct, for treatment of patients with relapsed or refractory multiple myeloma who have received at least four lines of therapy. This agent belongs to a novel class of T-cell engagers.

HPN217 is currently the subject of an ongoing phase I/II trial that is studying the agent’s effects on patients with relapsed or refractory multiple myeloma. Interim results for the trial were presented at the 2021 American Society of Hematology Annual Meeting & Exposition, which confirmed the safety of administering HPN217 at a weekly dose of 2,150 µg. Study of dose escalation is currently ongoing, with common treatment-emergent adverse effects including anemia, neutropenia, and thrombocytopenia.


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