Teclistamab/Daratumumab Approval May Bolster Patient-Centric Myeloma Care

In December 2025, the FDA awarded a national priority voucher to teclistamab-cqyv (Tecvayli) plus daratumumab (Darzalex) for patients with relapsed/refractory multiple myeloma under the Commissioner’s National Priority Voucher pilot program. This pilot program is designed to accelerate the review of products that may address various key national health priorities, with completed review decisions targeted for 1 to 2 months after the submission of an application.

Considering this development, Surbhi Sidana, MD, spoke with CancerNetwork^® about the implications of the regulatory approval of the teclistamab/daratumumab combination. According to Sidana, an associate professor of medicine and lead of the Myeloma CAR-T/Immunotherapy Program at Stanford University in California, a potential approval would provide another “highly effective” option in the multiple myeloma armamentarium. With more options at hand, she noted that patients could opt for chimeric antigen receptor (CAR) T-cell therapy at first relapse or more conventional strategies, depending on individual preferences or factors such as frailty or proximity to a treatment center.

Transcript:

If approved, the [teclistamab/daratumumab] combination, which is highly effective—[with] the best 3-year PFS [progression-free survival] that we’ve seen to date—offers another option in the myeloma armamentarium. It doesn’t mean to say one option…or the other option is the only way to go. It gives one more effective option. As a doctor, I can sit in front of my patient and say, "OK, tell me your values. Tell me what you prioritize. Tell me what you can reasonably have access to."

We want to be patient-centric. This gives our patients options. They can have the option of CAR T at first relapse if they want a limited-duration therapy that can have a long treatment-free interval and PFS. But on the other hand, if they can’t live or go close to a center that offers CAR T, and they’re OK with the continuous nature of this therapy [while undergoing treatment] closer to home, this gives an effective—even the PFS likely looks better—option. Of course, there are conventional therapies. What if someone’s frail, and we don’t know how they’ll do with any of those [treatments]? There are also other options.

This [potential approval] gives us a highly effective option. For the first time, we are seeing a plateau in our curve, and maybe some of these patients with these immunotherapy-based approaches—which is now what we see with [daratumumab/teclistamab]—we’ll see some with ciltacabtagene autoleucel; Carvykti] be cured in the long term. That, for me, is what I’m really hoping we will achieve in the next few years: for a proportion of patients, maybe a small proportion, that we’ll be able to achieve a functional cure.

Reference

FDA proactively awards national priority voucher based on strong phase 3 study results. News release. FDA. December 15, 2025. Accessed January 15, 2026. https://tinyurl.com/2x9uvufa