How Would the Teclistamab Combo Approval Transform Multiple Myeloma?

Teclistamab-cqyv (Tecvayli) in combination with daratumumab (Darzalex) may offer a “highly effective option” that bolsters patient-centric care in multiple myeloma, according to Surbhi Sidana, MD.

In December 2025, the FDA awarded a national priority voucher to teclistamab/daratumumab for those with relapsed/refractory multiple myeloma as part of the Commissioner’s National Priority Voucher pilot program.¹ The pilot program may accelerate the review of products designed to address various important national health priorities, expediting the review process to 1 to 2 months after an application’s submission.

Sidana, associate professor of medicine and lead of the Myeloma CAR-T/Immunotherapy Program at Stanford University in California, spoke with CancerNetwork^® about the potential implications this anticipated approval would have on the multiple myeloma paradigm. She also highlighted how other initiatives in the multiple myeloma space may bring novel cellular therapies into earlier treatment settings. Additionally, she emphasized the roles that organizations like the National Institutes of Health (NIH) and the American Society of Hematology (ASH) can play in continuing to fund and support research across hematologic oncology.

The priority review voucher came in the wake of findings from the phase 3 MajesTEC-3 trial (NCT05083169), which evaluated teclistamab plus daratumumab vs subcutaneous daratumumab with pomalidomide (Pomalyst) and dexamethasone (DPd) or bortezomib (Velcade) and dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma.² Data showed that the median progression-free survival (PFS) was not reached in the teclistamab arm vs 18.1 months in the comparator arm (HR, 0.17; 95% CI, 0.12-0.23; P <.0001).

CancerNetwork: If approved, what utility would the teclistamab/daratumumab combination offer compared with other therapeutic strategies in relapsed/refractory multiple myeloma?

Sidana: If approved, the [teclistamab/daratumumab] combination, which is highly effective—[with] the best 3-year PFS 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. On the other hand, if they can’t live or [travel] 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 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.

Are there any patient subgroups with relapsed/refractory multiple myeloma who may especially benefit from treatment with teclistamab plus daratumumab?

All the subgroups benefited from this combination. It’s hard to cherry pick one that may benefit more than the other, so I would say it is effective for all subgroups. Again, at the time of first relapse, when we have many options, I would say for [patients] who are high risk [or] have extra medullary disease, we always want to be more aggressive. Whether it’s CAR T or [daratumumab/teclistamab], I would pick those options over conventional chemotherapy options, particularly in patients who either have functional high-risk disease or high-risk disease.

Beyond this potential approval, what other anticipated updates or developments in the multiple myeloma field may impact the treatment paradigm?

With everything in multiple myeloma, we start with a late relapse. This is what we did with CAR T-cell therapy and bispecifics. Now, we are moving into early relapse. What we don’t know is [daratumumab/teclistamab] data vs [teclistamab] alone. That will be another thing. Teclistamab alone is also being studied. How much bang for [your] buck does the combination add vs teclistamab alone in this setting? That is also going to be known soon by future studies or ongoing studies.

Now, these combinations are being tested in the frontline setting. There’s a large European Myeloma Network study [NCT05243797] that is testing teclistamab in the maintenance setting after autologous transplant.³ There are also studies looking at teclistamab as induction therapy. Can we use bispecific antibodies [like teclistamab/talquetamab-tgvs (Talvey)] in lieu of transplant? It’s being explored in all stages of multiple myeloma. In fact, it’s also being explored in smoldering myeloma.

Is there anything else you would like to highlight?

A lot of understanding about T-cell biology that informs this research happened from NIH dollars. Today, NIH research dollars are at risk. None of this would be possible if, 30 years ago, we had not invested in research looking at how T cells work and how they kill cancer. This is very important to raise awareness [for]. ASH is doing a campaign called Fight4Hematology, where they’re continuing to raise awareness and support so that we can preserve this research funding. The advances from today will fuel such research 10 to 15 years from now.

References

1. FDA proactively awards national priority voucher based on strong phase 3 study results. News release. FDA. December 15, 2025. Accessed February 2, 2026. https://tinyurl.com/2x9uvufa
2. Mateos M-V, Bahlis N, Perrot A, et al. Phase 3 randomized study of teclistamab plus daratumumab versus investigator’s choice of daratumumab and dexamethasone with either pomalidomide or Bortezomib (DPd/DVd) in patients (Pts) with relapsed refractory multiple myeloma (RRMM): Results of majestec-3. Blood. 2025;146(suppl 2): LBA-6. doi:10.1182/blood-2025-LBA-6
3. Phase 3 study of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone in participants with newly diagnosed multiple myeloma as maintenance therapy following autologous stem cell transplantation (MajesTEC-4). ClinicalTrials.gov. Updated December 30, 2025. Accessed February 2, 2026. https://tinyurl.com/2hvr225a