NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) on Friday reported new positive results from the Phase 3 MajesTEC-9 study evaluating TECVAYLI in patients with relapsed or refractory multiple myeloma treated as early as second line.
The study showed that treatment with TECVAYLI reduced the risk of disease progression or death by 71% and lowered the risk of death by 40% compared with standard-of-care therapies in patients who had received one to three prior lines of treatment.
Further, nearly two-thirds of patients treated with TECVAYLI achieved a complete response or better, compared with 16.8% of patients receiving standard treatment.
The safety profile of TECVAYLI was consistent with previous findings, with treatment-emergent adverse events broadly similar to those seen with standard-of-care therapies.
The company said the positive MajesTEC-9 results further support the use of TECVAYLI as early as second-line treatment, following the recent approval of TECVAYLI plus DARZALEX FASPRO for adults with relapsed or refractory multiple myeloma who have received at least one prior therapy.
Based on the study results, Johnson & Johnson said it is working with regulators globally to expand the use of TECVAYLI as early as second-line treatment. Regulatory applications have already been submitted to the U.S. Food and Drug Administration and the European Medicines Agency.
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