Halozyme Says J&J Wins FDA Approval For Tecvayli, Darzalex Faspro Combo In Multiple Myeloma

Halozyme Therapeutics

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(RTTNews) - Halozyme Therapeutics Inc. (HALO) on Friday said Johnson & Johnson has received approval from the U.S. Food and Drug Administration for Tecvayli in combination with Darzalex Faspro to treat adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.

Darzalex Faspro is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE drug delivery technology.

The approval is based on positive results from the MajesTEC-3 Study, which evaluated Tecvayli plus Darzalex Faspro against standard daratumumab-based regimens in patients with relapsed or refractory multiple myeloma who had received at least one prior therapy.

The combination significantly improved progression-free and overall survival, reducing the risk of disease progression or death by 83% compared with standard treatments after a median follow-up of three years.

Halozyme shares closed at $67.36 on Thursday, down 3.8%.