Halozyme partner J&J wins FDA nod for myeloma combo featuring ENHANZE tech
Halozyme Therapeutics (NASDAQ:HALO) shares were in focus Friday after partner Johnson & Johnson secured U.S. regulatory approval for a subcutaneous combination therapy that significantly reduces the risk of disease progression in patients with relapsed multiple myeloma.
The U.S. Food and Drug Administration (FDA) has approved the combination of TECVAYLI (teclistamab) and DARZALEX FASPRO for adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
The decision, announced March 6, 2026, marks a major milestone for Halozyme , as DARZALEX FASPRO utilizes the company’s proprietary ENHANZE drug delivery technology to enable rapid subcutaneous administration.
The approval was granted under the FDA's National Priority Review Voucher program following "unprecedented" data from the Phase 3 MajesTEC-3 trial.
In the study, the combination regimen demonstrated a statistically significant improvement in both progression-free survival (PFS) and overall survival (OS) compared to standard-of-care treatments.
This efficacy profile positions the regimen as a potential new standard of care for patients as early as the second line of treatment.
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