FDA Breakthrough Therapy Designation Granted for Relapsed or Refractory Multiple Myeloma Treatment
New Jersey-based Janssen Pharmaceutical Companies announced today that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Therapy Designation (BTD) for teclistamab to treat relapsed or refractory multiple myeloma.
This distinction for teclistamab, an off-the-shelf, T-cell redirecting, a bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 receptors, follows a PRIME designation from the European Medicines Agency received earlier in 2021.
“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 release.
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, says Cancer.net. When damaged, these plasma cells rapidly spread and replace normal cells with tumors in the bone marrow. In 2021, it is estimated that nearly 35,000 people will be diagnosed, and more than 12,000 will die from the disease in the USA.
The 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.
The Breakthrough and PRIME designations are 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 be intolerant of those established multiple myeloma therapies.
Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Learn more at www.janssen.com.