Myeloma Combo With 'Unprecedented' Effect Wins FDA Approval

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Source: MedPage Today

Original: https://www.medpagetoday.com/hematologyoncology/myeloma/120201...

Published: Fri, 06 Mar 2026 13:43:08 -0500

The US FDA has approved the combination of teclistamab (Tecvayli) and daratumumab hyaluronidase (Darzalex Faspro) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior treatment[1][3]. The approval was based on the results of the MajesTEC-3 clinical trial with 587 patients who had one to three prior treatments[1]. Patients treated with the combination of teclistamab and daratumumab achieved unprecedented results - after almost three years of follow-up, the median progression-free survival did not reach the final value, while patients on standard treatment had a median of 18.1 months[1]. Adverse events were minimal – all cases of cytokine release syndrome were grade 1 or 2 and all resolved[3]. Teclistamab is an immunotherapy drug called a bispecific antibody that was originally approved in 2022 as a stand-alone therapy for difficult-to-treat patients[1]. This approval allows the use of teclistamab in the earlier phase of treatment in combination with daratumumab[1].