Janssen Receives FDA Breakthrough Therapy Designation for Multiple Myeloma mAb

The Janssen Pharmaceutical Companies of Johnson & Johnson announced on June 1, 2021 that FDA has granted breakthrough therapy designation for teclistamab, an off-the-shelf, T-cell redirecting, bispecific antibody, for treating relapsed or refractory multiple myeloma. FDA’s designation follows a priority medicines (PRIME) designation granted by the European Medicines Agency in January this year. In 2020, the European Commission and FDA each granted teclistamab orphan drug designation for the treatment of multiple myeloma.

Teclistamab targets both B-cell maturation antigen (BCMA), which is expressed at high levels on multiple myeloma cells, and CD3 receptors. The bispecific antibody redirects CD3-positive T-cells to BCMA-expressing myeloma cells to induce killing of tumor cells. Results from preclinical studies demonstrated that teclistamab kills myeloma cell lines and bone marrow-derived myeloma cells from heavily pretreated patients. Teclistamab is currently in Phase II clinical development and is also being explored in combination studies.

“We are pleased to have received [b]reakthrough [t]herapy and PRIME [d]esignations for our novel bispecific antibody, teclistamab,” said Peter Lebowitz, MD, PhD, Global Therapeutic Area head, Oncology, Janssen Research & Development, in a company 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.”