First European filing submission for multiple myeloma bispecific antibody
pharmafile | February 2, 2022 | News story | Research and Development |
Janssen has announced the submission of a Marketing Authorisation Application (MAA) to the EMA, seeking approval for off-the-shelf-bispecific antibody teclistamab, for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).
Teclistamab is an investigational, off-the-shelf, T-cell redirecting, bispecific antibody, targeting both B-cell maturation antigen (BCMA) and CD3. The submission to the EMA is supported by data from MajesTEC-1, an open-label, multicentre clinical trial, evaluating the safety and efficacy of teclistamab in adults with RRMM.
“Despite the significant progress that has been made in the treatment of multiple myeloma, it remains an incurable cancer, with approximately half of newly diagnosed patients not reaching five-year survival and almost a third dying within one year of diagnosis,” said Edmond Chan MBChB MD (Res), Senior Director, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. “Today’s submission is an important step forward in our mission to improve outcomes for people living with multiple myeloma, where the need for new treatment strategies remains high.”
This marks the first European filing submission for a bispecific antibody for the treatment of multiple myeloma. If approved, teclistamab will provide a novel treatment option for patients who have relapsed, or become refractory to prior lines of therapy.
In December 2021 the EMA granted accelerated assessment for teclistamab, which reduces the timeframe for the CHMP to review a MAA, and is granted to medicinal products of major interest to public health and therapeutic innovation.
Multiple myeloma is currently an incurable blood cancer that affects plasma cells, a type of white blood cell. White blood cells are found in the bone marrow, and when damaged, can grow out of control. Abnormal plasma cells can crowd out or suppress the growth of other healthy cells in the bone marrow. More than 50,900 people were diagnosed with multiple myeloma in Europe in 2020, and more than 32,500 patients died.
Ana Ovey
