U.S. FDA Approves TECVAYLI® in Combination with DARZALEX FASPRO® for Relapsed or Refractory Multiple Myeloma
Halozyme Therapeutics has announced that Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for the use of TECVAYLI (teclistamab-cqyv) in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) to treat adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously received at least one line of therapy. The regulatory decision marks an important advancement in the evolving treatment landscape for patients with this challenging blood cancer, particularly those whose disease has progressed following earlier treatments.
Multiple myeloma is a complex and incurable cancer of plasma cells that often requires several lines of therapy over the course of the disease. Although recent years have brought numerous therapeutic innovations, many patients eventually experience disease relapse or develop resistance to available therapies. The newly approved combination therapy offers an additional treatment option that aims to improve outcomes while providing convenient administration for patients and healthcare providers.
A notable feature of this regimen is that both therapies—TECVAYLI and DARZALEX FASPRO—are administered subcutaneously. Subcutaneous delivery can reduce treatment times and improve patient convenience compared with traditional intravenous infusions, potentially allowing therapy to be delivered in a wider range of care settings, including community oncology practices.
According to Dr. Helen Torley, President and Chief Executive Officer of Halozyme Therapeutics, the approval represents a significant milestone for patients and clinicians managing relapsed or refractory multiple myeloma. She emphasized that the combination regimen offers a highly effective treatment option that can be delivered across multiple healthcare environments. Dr. Torley also highlighted the role of Halozyme’s proprietary drug-delivery platform in the DARZALEX FASPRO formulation.
DARZALEX FASPRO incorporates Halozyme’s ENHANZE® drug-delivery technology, which uses recombinant human hyaluronidase to facilitate the rapid and efficient subcutaneous administration of biologic medicines. This technology enables large-volume biologics such as daratumumab to be delivered under the skin rather than through lengthy intravenous infusions. Since its introduction, the ENHANZE platform has been widely adopted across the biopharmaceutical industry and has contributed to the development of several subcutaneous therapies designed to improve patient experience.
The FDA approval is supported by results from the Phase 3 MajesTEC-3 clinical trial, an ongoing randomized study designed to evaluate the safety and efficacy of the teclistamab and daratumumab combination compared with established treatment regimens. The study enrolled patients with relapsed or refractory multiple myeloma who had received at least one prior therapy. Participants were randomly assigned to receive TECVAYLI plus DARZALEX FASPRO or the investigator’s choice of standard regimens consisting of daratumumab and dexamethasone combined with either pomalidomide or bortezomib.
Data from the MajesTEC-3 trial demonstrated substantial improvements in clinical outcomes for patients treated with the combination therapy. After a median follow-up period of three years, the regimen showed statistically significant improvements in both progression-free survival (PFS) and overall survival (OS) compared with standard treatment options. These results highlight the potential of the therapy to meaningfully extend the time patients live without disease progression while also improving long-term survival outcomes.
One of the most striking findings from the study was the dramatic reduction in the risk of disease progression or death. The TECVAYLI plus DARZALEX FASPRO regimen reduced this risk by approximately 83 percent compared with the standard treatment regimens evaluated in the trial. The hazard ratio was reported as 0.17, with a 95 percent confidence interval ranging from 0.12 to 0.23, and the results achieved strong statistical significance with a p-value of less than 0.0001.
In addition to reducing the likelihood of disease progression, the therapy demonstrated durable benefits over time. The three-year progression-free survival rate reached 83 percent among patients receiving the combination regimen, indicating that a large majority of treated patients remained free from disease progression for an extended period. These findings suggest that the therapy may provide sustained control of multiple myeloma in patients who previously had limited treatment options.
TECVAYLI is a bispecific antibody that targets both B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3 receptors on T cells. By binding to both targets simultaneously, the therapy redirects the patient’s immune system to recognize and destroy cancerous plasma cells. When TECVAYLI combined with DARZALEX FASPRO—a CD38-targeting monoclonal antibody—the regimen employs complementary mechanisms of action designed to enhance anti-tumor immune activity.
The approval underscores the continued progress being made in immunotherapy-based approaches for multiple myeloma, an area that has seen rapid innovation in recent years. Bispecific antibodies, CAR-T cell therapies, and novel antibody-drug combinations are reshaping the treatment paradigm and offering new hope to patients with difficult-to-treat disease.
For patients living with relapsed or refractory multiple myeloma, the availability of an effective subcutaneous combination therapy represents a meaningful advance in both clinical outcomes and treatment convenience. As TECVAYLI ongoing research continues to explore additional combinations and earlier-line uses of these therapies, clinicians remain optimistic that the expanding arsenal of targeted treatments will further improve survival and quality of life for patients affected by this complex cancer.
About Halozyme
Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As TECVAYLI the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme’s TECVAYLI commercially-validated solution facilitates the subcutaneous delivery of injected drugs and fluids, reducing treatment burden and improving convenience. ENHANZE® has touched more than one million patient lives through ten commercialized products across over 100 global markets and is licensed to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, Acumen Pharmaceuticals, Merus N.V. and Skye Bioscience.
Halozyme expanded its drug delivery technology portfolio to develop partner products using Hypercon™ and Surf Bio’s hyperconcentration technology. Hypercon™ is an innovative microparticle technology expected to set a new standard in hyperconcentration of drugs and biologics by reducing injection volume for the same dosage and enabling administration in at‑home and healthcare‑provider settings. The addition of Surf TECVAYLI Bio’s polymer‑based hyperconcentration technology further broadens the range of biologics that can be delivered subcutaneously, meaningfully expanding the scope of opportunities across therapeutic modalities. Together, Hypercon™ and Surf Bio’s technology complement ENHANZE® by enabling creation and delivery of highly concentrated biologics. The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Janssen, Eli Lilly and argenx.
Halozyme also develops, manufactures and commercializes drug-device combination products using advanced auto-injector technologies designed to improve convenience, reliability and tolerability, enhancing patient comfort and adherence. The TECVAYLI Company has two proprietary commercial products, Hylenex® and XYOSTED®, partnered commercial products and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc.
Halozyme is headquartered in San Diego, CA, with offices in Ewing, NJ; Minnetonka, MN; and Boston, MA. Minnetonka is also the site of its operations facility.
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