Janssen submits Teclistamab Biologics License Application to the US FDA in a Quest for approval

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The US Food and Drug Administration (FDA) has approved Janssen’s Teclistamab for the treatment of relapsed or refractory Multiple Myeloma.

Johnson & Johnson’s Janssen Pharmaceutical Companies stated on Wednesday that they have submitted a Biologics License Application (BLA) to the US Food and Drug Administration. The Food and Drug Administration (FDA) is considering whether teclistamab should be approved for the treatment of individuals with relapsed or refractory multiple myeloma (R/R). Teclistamab is an off-the-shelf investigational antibody for T-cell redirection that targets both B-cell maturation antigen (BCMA) and CD3.

“Despite all the gains that have been made in treating multiple myeloma, the unmet need still remains very high. Our relentless pursuit of treatments for this disease continues with the same sense of urgency that we have always had. We look forward to working with the FDA in their review of our teclistamab submission,”  said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC.

MajesTEC-1, an open-label, multicenter clinical trial examining the safety and efficacy of teclistamab in adults with R/R multiple myeloma, was used to support the BLA submission for teclistamab. Investigators looked at efficacy outcomes such as overall response rate, very good partial response, and complete response using International Myeloma Working Group (IMWG) criteria, as well as teclistamab’s safety profile. MajesTEC-1 data was recently presented at the annual conference of the American Society of Hematology.

“The deep expertise, creativity and persistence of the entire Janssen R&D organization enabled the expeditious advancement of teclistamab for multiple myeloma. Today’s submission is another important step in our commitment to bring to patients truly transformational medicines that profoundly impact their health,”

said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. 

Multiple myeloma is an incurable blood cancer that affects plasma cells, which are white blood cells that ordinarily produce antibodies to combat infection and are found in the bone marrow. Multiple myeloma cells proliferate and replace normal cells in the bone marrow when these plasma cells become malignant and develop into multiple myeloma. Nearly 35,000 people will be diagnosed with this disease in the United States in 2021, with more than 12,000 people dying from it. While some individuals with multiple myeloma have no symptoms at first, many are diagnosed after experiencing symptoms such as bone fractures or pain, low red blood cell counts, fatigue, excessive calcium levels, kidney difficulties, or infections.

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