The FDA believes that data on MRD and complete response can expedite new drug delivery compared with long-term survival ...

The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...

The CEPHEUS trial is a trial for newly diagnosed multiple myeloma patients who are not eligible for stem cell transplantation, or in whom a transplant was deferred. And 395 patients were randomized ...

After a short delay and concerns of potential intervention from senior officials, the FDA has issued a draft guidance for the industry on the potential use of minimal residual disease (MRD) and ...

Carvykti sales surge, MRD FDA guidance speeds label expansion, and strong cash runway. Click for more on LEGN stock.

Daratumumab-lenalidomide maintenance significantly increases MRD-negative conversion and reduces progression risk in multiple myeloma, with consistent efficacy across age, race, and risk groups.

Adding blinatumomab to consolidation chemotherapy for B-cell precursor acute lymphoblastic leukemia (BCP-ALL) in patients without measurable residual disease (MRD) led to improvements in overall and ...

A Darzalex-based regimen improved MRD negativity rates compared with VRd in patients with newly diagnosed, transplant-eligible multiple myeloma. Darzalex (daratumumab) plus Velcade (bortezomib), ...

(RTTNews) - Johnson & Johnson (JNJ) announced new results from the Phase 3 CARTITUDE-4 study that show a single infusion of CARVYKTI (ciltacabtagene autoleucel; cilta-cel) significantly increased ...

In a new trial, patients with B-acute lymphoblastic leukemia (B-ALL) who had no evidence of remaining cancer cells after prior treatment, experienced comparable outcomes whether they received ...

Researchers found that the outcomes were excellent for the 178 end of first consolidation measurable residual disease (MRD)-negative patients, regardless of MRD results at later time points. HealthDay ...