Treatment of Relapsed or Refractory Multiple Myeloma Receives U.S. FDA Breakthrough Designation
The Janssen Pharmaceutical Companies of Johnson & Johnson announced on June 1, 2021, that the U.S. Food and Drug Administration (FDA) had 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 and CD3 receptors, follows a PRIME designation from the European Medicines Agency received earlier in 2021.
Results from preclinical studies demonstrate that teclistamab kills myeloma cell lines and bone marrow-derived myeloma cells from heavily pretreated patients.
“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, in a press statement.
The U.S. FDA grants BTD to expedite the development and regulatory review of an investigational medicine 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.
Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.