The European Commission has approved Tecvayli alone for adults with multiple myeloma that has returned or resisted treatment after at least one prior therapy, Johnson & Johnson announced on October 23. The decision brings the immunotherapy into an earlier treatment setting in the European Union, adding an option at first relapse.
The European Medicines Agency describes myeloma as a bone-marrow cancer. Tecvayli, or teclistamab, is injected under the skin and binds to BCMA on myeloma cells and CD3 on immune T cells, bringing them together to attack the cancer. The EMA says experienced doctors must supervise treatment in facilities able to manage severe reactions, including cytokine release syndrome.
The approval rests on the randomised phase 3 MajesTEC-9 trial. OncLive reports that 593 patients with one to three prior treatment lines received teclistamab or one of two standard regimens. Prior treatment included lenalidomide and an anti-CD38 antibody. These trial criteria describe the population studied and should not be confused with the broader wording of the announced approval.
According to the company, teclistamab reduced the relative risk of progression or death by 71% and of death by 40% against the comparison treatments. At 18 months, 69.8% were alive without progression, versus 26.9%; overall survival was 79.2% versus 68.6%. These group results do not mean that every patient benefits or that the medicine cures myeloma.
The benefits came with substantial risks. Johnson & Johnson reported grade 3 or 4 adverse events in 84.9% of teclistamab recipients versus 76.3% in the comparison groups. Grade 3 or 4 infections affected 41.6% versus 29.0%. Those findings underline the importance of specialist monitoring when assessing the treatment's benefits and harms.
The company says the revised schedule allows monthly dosing from month seven, or as early as month three for eligible patients. At the time of review, the EMA's public overview still described monotherapy after at least three previous treatments. The new extension is therefore attributed to the company's announcement, also reported by OncLive; the overview provides background on the medicine and its precautions.
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