FDA Grants Breakthrough Therapy Designation for Teclistamab to Treat Relapsed, Refractory Multiple Myeloma


Officials with the FDA have granted breakthrough therapy designation (BTD) for teclistamab in the treatment of relapsed or refractory multiple myeloma (RRMM). Teclistamab is an off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 receptors.1

Teclistamab redirects CD3-positive T-cells to BCMA-expressing myeloma cells in order to induce the killing of tumor cells. Preclinical study results have demonstrated that teclistamab kills myeloma cell lines and bone marrow-derived myeloma cells from heavily pretreated patients. The drug is currently being evaluated in a phase 2 clinical study for the treatment of RRMM and it is being evaluated in several combination studies as well.1

“We are pleased to have received Breakthrough Therapy and PRIME Designations for our novel bispecific antibody, teclistamab,” said Peter Lebowitz, MD, PhD, in a press release. “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’s BTD is supported by data from the phase 1 MajesTEC-1 study, an open-label, multicenter clinical trial evaluating the safety and efficacy of teclistamab in adults with measurable multiple myeloma that is relapsed or refractory to established therapies or intolerant of established multiple myeloma therapies.1 The results of the study indicated that 58% of patients receiving teclistamab achieved a very good partial response or better, and 40% achieved a complete response or better. The observed overall response rate was 65%.2

“We reported initial findings for teclistamab at ASCO 2020, and study updates have observed a deepening of responses that have shown to be durable in a significant percentage of patients with relapsed or refractory multiple myeloma,” said Amrita Y. Krishnan, MD, director of the Judy and Bernard Briskin Center for Multiple Myeloma Research, in a press release. “Teclistamab exposure was sustained across the dosing interval and exceeded target levels, and consistent T-cell activation was observed. With this latest follow-up data, we present further evidence of promising clinical activity in heavily pre-treated patients, who are in urgent need of new therapeutic options.”2

BTD is granted by the FDA in order 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. This designation for teclistamab follows a Priority Medicines designation from the European Medicines Agency earlier this year, which 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.1


  1. Janssen announces U.S. FDA Breakthrough Therapy Designation granted for teclistamab for the treatment of relapsed or refractory multiple myeloma [news release]. Johnson & Johnson; June 1, 2021. Accessed June 10, 2021. https://www.jnj.com/janssen-announces-u-s-fda-breakthrough-therapy-designation-granted-for-teclistamab-for-the-treatment-of-relapsed-or-refractory-multiple-myeloma
  2. Janssen’s updated phase 1 results for teclistamab suggest deep, durable responses in patients with heavily pretreated multiple myeloma [news release]. Business Wire; May 24, 2021. Accessed June 10, 2021. https://www.businesswire.com/news/home/20210524005459/en/Janssen%E2%80%99s-Updated-Phase-1-Results-for-Teclistamab-Suggest-Deep-Durable-Responses-in-Patients-with-Heavily-Pretreated-Multiple-Myeloma
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