FDA Approves Halozyme-Backed Combo Therapy for Relapsed Multiple Myeloma

Event summary

  • FDA approves TECVAYLI® (teclistamab-cqyv) in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for relapsed/refractory multiple myeloma (RRMM) on March 6, 2026.
  • Approval based on Phase 3 MajesTEC-3 study showing 83% reduction in risk of disease progression or death vs. standard regimens (HR 0.17, p<0.0001).
  • Three-year progression-free survival (PFS) rate of 83% demonstrated in the study.
  • Combination therapy administered subcutaneously using Halozyme's ENHANZE® drug delivery technology.

The big picture

This approval strengthens Halozyme's position as a key enabler of subcutaneous drug delivery technologies in oncology. The success of this combination therapy could accelerate adoption of Halozyme's ENHANZE® platform across other therapeutic areas, potentially expanding its partner network and revenue streams. The multiple myeloma market continues to see innovation in combination therapies, with this approval positioning Johnson & Johnson more competitively in the relapsed/refractory segment.

What we're watching

Commercialization Pace
How quickly Johnson & Johnson can scale the commercial rollout of this combination therapy in the competitive multiple myeloma market.
Technology Validation
Whether this approval will further validate and drive adoption of Halozyme's ENHANZE® drug delivery technology among other biopharmaceutical partners.
Pipeline Expansion
The pace at which Halozyme can leverage this success to expand its drug delivery technology portfolio, particularly with its Hypercon™ and Surf Bio technologies.