Hematogenix played a key role in the FDA's recent fast-tracked approval of Bristol Myers Squibb's ZENBEXUS™ (iberdomide), marking it as the first CELMoD therapy for multiple myeloma. Announced on August 19, 2026, this approval was backed by Hematogenix's proprietary Multiple Myeloma MRD (MM MRD) assay, which was crucial in measuring the trial's primary efficacy endpoint.
Based in Tinley Park, Illinois, Hematogenix is a global reference lab and contract research organization specializing in oncology and hematopathology. Their Next Generation Flow Cytometry (NGF) assay for MM MRD was used to evaluate ZENBEXUS's effectiveness for adult patients with multiple myeloma who have had at least one prior treatment.
The FDA's prescribing details for ZENBEXUS point out that the trial's major efficacy measure, MRD-negative complete response, was assessed with Hematogenix's NGF assay, with a sensitivity of 10-5. In the Phase 3 EXCALIBER-RRMM trial, patients treated with ZENBEXUS, daratumumab, hyaluronidase-fihj, and dexamethasone (ZDd) saw a 41% MRD-negative complete response rate. This was significantly better than the 21% seen with daratumumab, bortezomib, and dexamethasone (DVd), leading to the FDA's nod.
Dr. Hytham Al-Masri, Hematogenix's President and CEO, expressed pride in their lab's precision being recognized by the FDA. He emphasized the growing importance of MRD negativity as a measure of treatment success in multiple myeloma.
Regulatory bodies increasingly see MRD negativity — one residual tumor cell among 100,000 normal cells — as a key endpoint for accelerated approval in multiple myeloma. This highlights the need for specialized, standardized assays. Hematogenix's NGF MRD platform is designed to meet these rigorous standards for global trials.
This achievement shows Hematogenix's strategic role as a specialized reference lab and CRO, supporting major pharma sponsors with registrational-grade endpoints. They run CAP-accredited and CLIA-certified labs in the US, UK, Malaysia, and China, boosting their ability to back Phase 2 and 3 studies.
ZENBEXUS is meant for use with daratumumab, hyaluronidase-fihj, and dexamethasone in adults with multiple myeloma who have had prior therapy, including a proteasome inhibitor and an immunomodulatory agent. The FDA's accelerated approval hinges on confirming clinical benefits in further trials. ZENBEXUS has a Boxed Warning for embryo-fetal toxicity and serious blood clot risks, and is only available through the ZENBEXUS REMS program.
Hematogenix continues to support the changing multiple myeloma treatment field with its advanced diagnostic and biomarker assay capabilities. As MRD negativity becomes a key treatment success marker, Hematogenix is committed to providing reliable data that regulators, physicians, and patients can trust.
