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FDA Grants Approval for TECVAYLI® and DARZALEX FASPRO® Combination

Halozyme Therapeutics, Inc. has announced an important milestone in cancer treatment with the U.S. Food and Drug Administration's approval of TECVAYLI® (teclistamab-cqyv) in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj). This combination is now indicated for the treatment of adults suffering from relapsed or refractory multiple myeloma (RRMM) who have undergone at least one previous line of therapy.

The approval was granted based on promising results from the Phase 3 MajesTEC-3 trial, which evaluated the effectiveness and safety of the combination therapy against the standard treatment options. The results have shown that patients receiving the TECVAYLI® and DARZALEX FASPRO® regimen experienced substantial improvements in both progression-free survival (PFS) and overall survival (OS) rates when compared to standard care. Specifically, there was an impressive 83% reduction in the risk of disease progression or death. The median follow-up time for the study was three years, with a three-year PFS rate reported at an outstanding 83%.

Dr. Helen Torley, President and CEO of Halozyme, commented on the significance of this approval, stating that both TECVAYLI and DARZALEX FASPRO are administered subcutaneously, enhancing the treatment experience for patients with RRMM. This streamlined delivery method is part of ongoing advancements in multiple myeloma treatment options, offering hope for those battling this complex disease.

TECVAYLI® is a bispecific T-cell engager designed to link CD3 T-cells with BCMA (B-cell maturation antigen) on the surface of myeloma cells. This mechanism helps mobilize the body's immune response against cancer cells more effectively. Likewise, DARZALEX FASPRO® employs Halozyme's proprietary ENHANZE technology, which allows for the injection of the drug just beneath the skin instead of intravenously, further reducing the burden on patients.

The MajesTEC-3 clinical study set out to compare the efficacy of the new combination therapy with the traditional therapy which includes daratumumab alongside dexamethasone, and with either pomalidomide or bortezomib. The positive outcomes achieved in this research underline the necessity and impact new treatment regimens can have on the lives of patients dealing with advanced stages of multiple myeloma.

Beyond the immediate implications for those with RRMM, this approval underscores the continuous efforts being made in the field of biopharmaceuticals to innovate and simplify treatment strategies. Halozyme’s work with ENHANZE technology is pivotal; by facilitating subcutaneous drug delivery, they have improved patient convenience and have the potential to lower treatment-related discomfort.

Future studies and real-world implementation of this combination therapy will be closely watched, as they may reveal even further benefits over existing treatment methodologies.

In conclusion, the FDA's decision to approve the TECVAYLI® and DARZALEX FASPRO® combination represents a significant advancement for patients afflicted with relapsed or refractory multiple myeloma. It not only offers a new treatment option but also highlights the importance of innovative delivery methods in enhancing patient care and outcomes.

For more detailed information on this drug approval, please visit Johnson & Johnson's official press release issued on March 5, 2026.