Johnson & Johnson announced data highlighting that Darzalex Faspro (daratumumab and hyaluronidase-fihj)-based regimens improve overall and sustained minimal residual disease negativity rates and progression-free survival in patients with newly diagnosed multiple myeloma, regardless of transplant status.
In January, FDA released a draft guidance entitled “Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval.”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.
