Johnson & Johnson has announced that the CHMP has recommended approval of an indication extension for TECVAYLI (teclistamab) for adults with relapsed or refractory multiple myeloma who have received at least one prior therapy. The company said the opinion follows positive phase 3 results showing improved progression-free and overall survival versus standard of care.
Many patients relapse after first-line treatment and options become limited once the disease is refractory to anti-CD38 monoclonal antibodies and lenalidomide. Johnson & Johnson said there remains a critical need for effective immunotherapies in earlier treatment lines.
Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson, said: “Relapsed or refractory multiple myeloma remains a complex disease, with diverse and evolving patient needs. This positive CHMP opinion reflects the importance of teclistamab in multiple myeloma and further reinforces its potential as a foundational immunotherapy after first-line treatment.”
She added: “By providing steroid-sparing combination and monotherapy regimens, teclistamab has the potential to expand the choices for patients living with the disease and redefine what’s possible in multiple myeloma.”
Yusri Elsayed, Global Therapeutic Area Head, Oncology, Johnson & Johnson, explained: “Today’s recommendation reflects our longstanding commitment to transforming outcomes for patients with multiple myeloma by advancing innovative therapies, such as teclistamab, into earlier lines of treatment, where they have the greatest potential to change the trajectory of the disease.”
He added: “By investing across the treatment continuum, from established foundations of care to novel immunotherapies, we remain focused on delivering differentiated treatment options that address patients’ diverse needs at every stage of their disease, all with the goal of improving long-term outcomes and, where possible, moving people closer to durable remission and, ultimately, cure.”
The CHMP opinion is based on the phase 3 MajesTEC-9 study, which showed a 71% reduction in risk of progression or death and a 40% reduction in risk of death versus standard of care. Nearly two-thirds of patients achieved a complete response or better. Safety findings were consistent with previous studies.
Johnson & Johnson said the milestone builds on recent EU approval of teclistamab in combination with daratumumab, reinforcing the potential of teclistamab-based regimens across a broad second-line population.
