Teclistamab Combo Approval Affirms Role of Anti-BCMA Therapy in Myeloma

Teclistamab-cqyv (Tecvayli) plus daratumumab and hyaluronidase-fihj (Darzalex Faspro) has produced some of the “most exciting data” observed in relapsed/refractory multiple myeloma, according to María-Victoria Mateos, MD, PhD.

In a conversation with CancerNetwork^® following the FDA approval of teclistamab/daratumumab among those with relapsed/refractory multiple myeloma, Mateos described the clinical implications of this combination becoming available for patients. She spoke to the utility of switching to BCMA-directed therapies after an initial relapse based on progression-free and overall survival benefits observed in prior phase 3 trials. In particular, she highlighted the “synergistic combination” that teclistamab and daratumumab demonstrated in the phase 3 MajesTEC-3 trial (NCT05083169), which supported the regimen’s approval.

Mateos is the director of the Myeloma Program, a consultant physician in the Hematology Department, and associate professor of medicine at the University of Salamanca, Spain. She also serves as the Treasurer of the International Myeloma Society.

Transcript:

The approval of teclistamab plus daratumumab in [patients with] relapsed/refractory multiple myeloma after at least 1 prior line of therapy represents the first BCMA bispecific monoclonal antibody-based combination for patients with myeloma after at least 1 prior line of therapy.

The first important take-home message, based on all efficacy data we’ve seen with the BCMA-targeted therapies, is that after at least 1 prior line of therapy, when we have a patient [with myeloma] relapse, it is a good option to move immediately to BCMA-targeted therapies because all these combinations demonstrated, in phase 3 clinical studies, benefits in progression-free survival and overall survival. If we focus specifically on teclistamab and daratumumab, this combination resulted in a synergistic combination, and the efficacy data were maybe the most exciting data and the best efficacy data we’ve seen in [patients with] relapsed/refractory myeloma with this combination. In addition, this combination is based on anti-CD38 BCMA bispecific monoclonal antibodies, and it is an off-the-shelf combination that does not require any manufacturing process. This combination is going to be available in every center, not only academic, but also community-based centers.

Reference

FDA grants third approval under the National Priority Voucher Program. News release. FDA. March 5, 2026. Accessed March 25, 2026. https://tinyurl.com/45hhbpau