Johnson’s TECVAYLI monotherapy submitted for relapsed/refractory multiple myeloma after at least one prior therapy

Johnson & Johnson has recently announced the submission of a Type II variation application to the EMA seeking approval for an indication extension of TECVAYLI as monotherapy for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least one prior therapy.

Bringing new hope to a high unmet need population
Note that despite major advances in frontline multiple myeloma treatment, including anti-CD38-based quadruplet regimens, most patients will ultimately relapse. Outcomes are particularly poor once patients become refractory to key backbone therapies such as anti‑CD38 monoclonal antibodies and lenalidomide. This patient population has historically faced limited choices and challenging second-line treatment pathways, reinforcing the need for additional effective immunotherapy options that can be given across practice settings.

“A significant number of patients with multiple myeloma continue to relapse and become refractory to currently available therapies, representing one of the largest and most challenging unmet needs in the disease,” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “Making teclistamab monotherapy available to patients as early as second line, where it has the potential to meaningfully improve long-term outcomes and change the course of the disease, could bring new hope to patients and their families.”

MajesTEC-9 study results
The submission is supported by data from the Phase 3 MajesTEC-9 trial evaluating the efficacy and safety of teclistamab versus the standard of care of pomalidomide, bortezomib, and dexamethasone or carfilzomib and dexamethasone in 614 patients with RRMM.

The safety profile of teclistamab monotherapy was clinically manageable and consistent with its known profile, with no new safety signals identified. Infections can be managed with robust infection management protocols, which include patient monitoring, immunoglobulin therapy and antimicrobial prophylaxis.

“At Johnson & Johnson, we are driven by a clear purpose to deliver innovations that redefine expectations of what a multiple myeloma diagnosis means to patients, at every stage of the disease,” said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson. “With today’s regulatory milestone for teclistamab, we are advancing a widely available immunotherapy approach with the potential to support deep and sustained responses over time.”

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tecvayli