News|Articles|March 5, 2026

FDA Approves Tecvayli Combo for Relapsed or Refractory Myeloma

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Key Takeaways

FDA authorized teclistamab + daratumumab hyaluronidase for RRMM after ≥1 prior line with PI and IMiD exposure, expanding access earlier in the treatment sequence.
Traditional approval also formalized single-agent teclistamab after ≥4 prior lines including PI, IMiD, and anti-CD38 therapy, converting prior accelerated authorization.
MajesTEC-3 randomized 587 patients; teclistamab + daratumumab achieved median PFS not reached versus 18.1 months with investigator’s-choice daratumumab combinations.
Regulatory evaluation used expedited programs including Project Orbis, plus breakthrough, orphan, and priority review designations to accelerate assessment for a serious malignancy.
Boxed warnings for CRS and ICANS mandate Tecvayli-Talvey REMS; common toxicities included hypogammaglobulinemia, respiratory infections, diarrhea, pneumonia, COVID-19, fatigue, and pyrexia.

FDA approved Tecvayli plus Darzalex Faspro for relapsed or refractory multiple myeloma after prior therapy, based on trial results showing longer disease control.

The U.S. Food and Drug Administration (FDA) approved Tecvayli (teclistamab) in combination with Darzalex Faspro (daratumumab hyaluronidase-fihj) for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent on March 5, 2026. The decision gives patients with cancer another treatment option after earlier therapies stop working.

The approval expands use of Tecvayli beyond its earlier accelerated approval and converts that authorization to traditional approval for use as a single agent in adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.

Multiple myeloma is a blood cancer that affects plasma cells in the bone marrow. Patients with cancer whose disease returns after treatment often need additional options to help control disease growth and symptoms.

The approval was part of the FDA Commissioner’s National Priority Review Voucher pilot program.

How effective was Tecvayli plus Darzalex Faspro in the MajesTEC-3 trial?

The approval was based on results from MajesTEC-3, a randomized open-label multi-center trial that evaluated Tecvayli plus Darzalex Faspro compared with investigator’s choice control therapy.

Progression-free survival (PFS) was the main measure of effectiveness.

A total of 587 patients were randomized in the study. Of those, 291 received Tecvayli plus Darzalex Faspro. The remaining 296 received control therapy that included Darzalex Faspro plus either Pomalyst (pomalidomide) and dexamethasone or Velcade (bortezomib) and dexamethasone.

Median PFS was not reached in the Tecvayli plus Darzalex Faspro arm. Median PFS was 18.1 months in the control group.

The combination therapy lowered the risk of disease progression or death compared with control therapy.

Overall survival was also evaluated. Median overall survival was not reached in either study arm.

These findings suggest Tecvayli plus Darzalex Faspro may help patients with cancer maintain disease control longer compared with certain standard therapies.

How was the MajesTEC-3 trial reviewed by regulators?

The review was conducted under several FDA programs designed to speed development and evaluation of treatments for serious conditions, including Project Orbis.

Tecvayli received breakthrough designation, orphan drug designation and priority review because the therapy may provide meaningful improvement for patients with relapsed or refractory multiple myeloma.

What are the risks and side effects of Tecvayli combination therapy?

The prescribing information for Tecvayli includes a boxed warning for life threatening or fatal cytokine release syndrome (CRS) and neurologic toxicity including immune effector cell-associated neurotoxicity (ICANS).

Because of these risks, Tecvayli is available only through a restricted Risk Evaluation and Mitigation Strategy program called the Tecvayli-Talvey REMS.

Cytokine release syndrome occurs when the immune system releases too many inflammatory signals, which can cause fever, low blood pressure and breathing problems.

In addition to CRS, the most common side effects of Tecvayli plus Darzalex Faspro included hypogammaglobulinemia, upper respiratory tract infection, cough, diarrhea, musculoskeletal pain, COVID-19, pneumonia, injection site reaction, fatigue, pyrexia, headache, nausea, gastroenteritis and decreased weight.

Patients with cancer should talk with their healthcare team about symptom monitoring and risk management during treatment.

References

“FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma” U.S. Food and Drug Administration.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.

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