Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma

The Janssen Pharmaceutical Inc. of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for teclistamab in the treatment of relapsed or refractory multiple myeloma. This distinction for teclistamab, an off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 receptors, follows a PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA) received earlier this year. Today’s BTD marks the 11^th received by Janssen’s Oncology Therapeutic Area.

“We are pleased to have received Breakthrough Therapy and PRIME Designations for our novel bispecific antibody, teclistamab,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. “This program exemplifies our commitment to advancing science for patients living with multiple myeloma, and it builds upon our robust portfolio in this disease.”

The FDA grants BTD to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.¹ PRIME designation offers enhanced interaction and early dialogue to optimize development plans and speed up the evaluation of scientific advances that target a high unmet medical need.²

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