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, a 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.

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.
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.

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.

Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. 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 U.S.
While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, kidney problems or infections. ( Xagena_2021 )

Source: Janssen, 2021

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