Bristol-Myers Squibb CompanyFDA accelerated approval of ZENBEXUS, a new multiple myeloma therapy, expands Bristol Myers Squibb's product portfolio and market opportunity.

Hematogenix announced that its proprietary Next Generation Flow Cytometry assay for multiple myeloma minimal residual disease served as the analytical method for the pivotal efficacy endpoint supporting the FDA's accelerated approval of Bristol Myers Squibb's ZENBEXUS (iberdomide), the first CELMoD therapy approved for multiple myeloma. The FDA-approved prescribing information states that MRD-negative complete response was assessed using a Hematogenix Next Generation Flow Cytometry assay at a threshold of 10⁻⁵. In the Phase 3 EXCALIBER-RRMM trial, patients treated with ZENBEXUS in combination with daratumumab and hyaluronidase-fihj and dexamethasone achieved an MRD-negative complete response rate of 41%, compared with 21% for patients treated with daratumumab, bortezomib, and dexamethasone, a statistically significant improvement with p<0.0001. Hematogenix President and CEO Dr. Hytham Al-Masri said being named directly in the FDA label for the first approved therapy in a novel drug class validates the precision and scientific rigor of the company's laboratory platform. Hematogenix operates CAP-accredited and CLIA certified laboratories in the United States, United Kingdom, Malaysia, and China.
Bristol-Myers Squibb CompanyFDA accelerated approval of ZENBEXUS, a new multiple myeloma therapy, expands Bristol Myers Squibb's product portfolio and market opportunity.
Hematogenix's assay is named in the FDA label as the analytical method for the pivotal efficacy endpoint, validating its platform and likely increasing demand for its testing services.