NEW BRUNSWICK (dpa-AFX) - Friday, Johnson & Johnson (JNJ) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of an indication extension of TECVAYLI for the treatment of adult patients with relapsed/refractory multiple myeloma after at least one prior therapy.
The recommendation is backed by Phase 3 MajesTEC-9 study, evaluating the efficacy and safety of teclistamab as a monotherapy with pomalidomide, bortezomib and dexamethasone or carfilzomib and dexamethasone.
The study found significant improvements in both progression-free survival and overall survival. Also, it demonstrated a 71% reduction in the risk of disease progression or death and a 40% reduction in the risk of death compared to the standard of care.
In addition to this, all key secondary endpoints showed significant improvement with teclistamab versus standard of care, including nearly two-thirds of patients achieving a complete response or better.
The move also builds on the recent European Commission approval of teclistamab in combination with daratumumab, which was based on the results of the MajesTEC-3 study.
In pre-market hours, JNJ was trading at $269.40, down 0.30 percent on the NYSE.
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