WASHINGTON, March 12, 2026 — The U.S. Food and Drug Administration (FDA) has approved a new combination treatment for people with multiple myeloma that has returned or worsened after treatment with at least one prior therapy.
The new therapy pairs teclistamab (Tecvayli®) with daratumumab hyaluronidase-fihj. According to an announcement from the drug’s manufacturer, the two treatments “work synergistically to prime and activate the immune system to eradicate myeloma cells that express the BCMA protein.”
“This combination led to impressive results, both in terms of overall survival and progression-free survival times, for patients in the Majes-TEC-3 trial,” says Lore Gruenbaum, Ph.D., Blood Cancer United Chief Scientific Officer. “We have seen great progress in multiple myeloma treatments recently, and this new combination adds yet another important option to keep multiple myeloma patients healthier longer.”
While people with multiple myeloma are living longer than ever, the disease remains incurable. Patients will eventually experience relapses, and many will eventually run out of effective treatment options.
Making new treatments like teclistamab plus daratumumab available earlier in the disease course—after just one prior treatment—brings more treatment options to patients at a time when their immune systems are healthier and may be better able to respond to treatment.
Blood Cancer United’s Role in Advancing This Science
Blood Cancer United has played a long-term role in supporting the foundational research that paved the way for this approval. Over more than a decade, we have funded pioneering studies that helped establish CD38 as a target for the treatment of multiple myeloma. This critical scientific insight ultimately led to the development of anti‑CD38 antibodies, including daratumumab.
Our support includes:
- Funding early research that first characterized CD38’s role in myeloma biology, laying the foundation for therapeutic targeting.
- Providing funding to investigators at the University of Pennsylvania and Emory University as they researched innovative ways to develop drugs to target CD38.
- Funding for a multi‑center study at The University of Texas MD Anderson Cancer Center evaluating isatuximab, another CD38‑targeting antibody, as early intervention for high‑risk smoldering myeloma.
- Investing in early scientific work on novel targets for bispecific antibodies, the treatment class to which teclistamab belongs.
We are also looking to the future. Today we are funding an ongoing study looking at the possibility of using limited-duration treatment with teclistamab for multiple myeloma, so patients won’t have to stay on therapy indefinitely.
“This approval is due to years of scientific progress, and it will be a meaningful improvement for many people living with multiple myeloma,” says Dr. Gruenbaum. “We’re proud that our early investments in CD38 science and our ongoing funding of bispecific antibody research help lay the groundwork for discoveries like this. Seeing those foundational insights translate into real treatment options for patients is exactly why we do this work.”
If you or a loved one need personalized disease, treatment or support information, you can contact one of our Information Specialists here.