Inflammatory immune cells predict survival, relapse in MM, WashU-led study finds

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters most
Draft guidance consolidates trial design updates for developers

In January, FDA released a draft guidance entitled “Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints to Support Accelerated Approval.”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.

April 03, 2026

Vol.52 No.13

By Nicholas Richardson

Clinical Roundup

Positive phase III results announced from the SUCCESSOR-2 study of oral mezigdomide in r/r MM

Oral mezigdomide in combination with carfilzomib and dexamethasone demonstrated statistically significant and clinically meaningful improvement in progression-free survival versus carfilzomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma, according to positive interim phase III results from the SUCCESSOR-2 study.

March 13, 2026

Vol.52 No.10

Drugs & Targets

FDA accepts NDA for iberdomide in patients with r/r MM

FDA accepted a New Drug Application for iberdomide combined with standard treatment, daratumumab + dexamethasone, (also called IberDd )in patients with relapsed or refractory multiple myeloma. Iberdomide is part of an investigational, new class of medicines called cereblon E3 ligase modulator agents. FDA has granted a Prescription Drug User Fee Act date of Aug. 17 for this indication.

February 20, 2026

Vol.52 No.07

Drugs & Targets

FDA approves Darzalex Faspro as quad regimen for all newly diagnosed MM

FDA has approved Darzalez Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. D-VRd is the only anti-CD38 antibody-based regimen with approved indications across newly diagnosed patients, regardless of transplant eligibility.

January 30, 2026

Vol.52 No.04

Clinical Roundup

Tecvayli monotherapy demonstrates superior PFS and OS vs. standard of care in MM

Johnson & Johnson announced positive topline results from the investigational phase III MajesTEC-9 study of Tecvayli (teclistamab-cqyv) monotherapy, showing a 71% reduction in the risk of disease progression or death and a 40% reduction in the risk of death in a patient population that was predominantly refractory to anti-CD38 therapy and lenalidomide.

January 16, 2026

Vol.52 No.02

Obituary

Patient advocate David Mitchell, 75, dies of multiple myeloma

David Mitchell, a tireless patient advocate whose lived experience with multiple myeloma shaped a decade of courageous leadership on behalf of patients nationwide, died Jan. 2. He was 75.

January 09, 2026

Vol.52 No.1

By Ellen V. Sigal

Inflammatory immune cells predict survival, relapse in MM, WashU-led study finds

YOU MAY BE INTERESTED IN

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters most
Draft guidance consolidates trial design updates for developers

Positive phase III results announced from the SUCCESSOR-2 study of oral mezigdomide in r/r MM

FDA accepts NDA for iberdomide in patients with r/r MM

FDA approves Darzalex Faspro as quad regimen for all newly diagnosed MM

Tecvayli monotherapy demonstrates superior PFS and OS vs. standard of care in MM

Patient advocate David Mitchell, 75, dies of multiple myeloma

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Inflammatory immune cells predict survival, relapse in MM, WashU-led study finds

YOU MAY BE INTERESTED IN

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters mostDraft guidance consolidates trial design updates for developers

Positive phase III results announced from the SUCCESSOR-2 study of oral mezigdomide in r/r MM

FDA accepts NDA for iberdomide in patients with r/r MM

FDA approves Darzalex Faspro as quad regimen for all newly diagnosed MM

Tecvayli monotherapy demonstrates superior PFS and OS vs. standard of care in MM

Patient advocate David Mitchell, 75, dies of multiple myeloma

Never miss an issue!

Login

FDA’s guidance on MRD in MM goes beyond the ODAC vote—and that’s where it matters most
Draft guidance consolidates trial design updates for developers