A new four-drug combination therapy for multiple myeloma developed by Johnson & Johnson has been deferred by the U.S. Food and Drug Administration (FDA) due to unknown problems with a third-party manufacturing. The FDA’s Complete Response Letter (CRL) for the firm’s supplementary biologics license application (sBLA) for Darzalex Faspro (daratumumab and hyaluronidase-fihj) was shared by the company.
For patients with newly diagnosed multiple myeloma who are not eligible for a transplant, the sBLA aimed to extend the usage of Darzalex Faspro to a quadruplet regimen. The Phase 3 CEPHEUS study’s positive results, which were reported at the 2024 International Myeloma Society Annual Meeting, served as the foundation for this application.
Promising Clinical Trial Results
The regimen comprising Darzalex Faspro showed notable advantages in the Phase 3 CEPHEUS investigation. With a notable improvement in the overall minimal residual disease (MRD) negative rate, the study achieved its main goal. In comparison to the standard of care, the therapy has also shown improvements in the rate of complete response (CR) and progression-free survival (PFS).
Read More: European Commission Approves DARZALEX® for Treating High-Risk Smouldering Multiple Myeloma
Manufacturing Issues Stall Approval
The clinical information from the CEPHEUS research had nothing to do with the FDA’s ruling. Rather, the CRL was given after a third-party manufacturing facility that was included in the submission was inspected. The plant is now shuttered. In order to move the new indication forward as soon as feasible, Johnson & Johnson has committed to promptly addressing the inspection’s unresolved observations.
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