The combination of Tecvayli (teclistamab-cqyv), a bispecific T-cell engager antibody therapy, and Darzalex Faspro (daratumumab and hyaluronidase-fihj), a subcutaneous CD38-directed antibody, met the primary endpoint of progression-free survival and the results were statistically significant and superior to standard of care in relapsed/refractory multiple myeloma who received one to three prior lines of therapy, according to data from the phase III MajesTEC-3 study. This was compared to the investigator’s choice of Darzalex Faspro, pomalidomide, and dexamethasone or Darzalex Faspro, bortezomib, and dexamethasone.
In January, FDA released a draft guidance entitled “Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval.” This release came roughly 20 months after the Oncologic Drugs Advisory Committee (ODAC) voted unanimously that minimal residual disease (MRD) negativity, in combination with complete response (CR), is an acceptable primary endpoint to support accelerated approval for multiple myeloma (MM) therapies.
