Japan’s Ministry of Health, Labour, and Welfare has accepted for review a new drug application for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone or pomalidomide plus dexamethasone as a treatment for relapsed or refractory multiple myeloma.
The Multiple Myeloma Research Foundation’s CoMMpass study, a prospective, longitudinal observational study of 1,143 newly diagnosed, previously untreated multiple myeloma patients, revealed critical genetic markers that can better predict disease progression and identify patients at risk of transitioning to more aggressive forms of the disease.
A 12-year observational study which aimed to sequence the genome, exome, and RNA in tumors from patients with multiple myeloma was able to define distinct subtypes of the disease, according to an international team of scientists led by researchers from the Translational Genomics Research Institute, part of City of Hope.
Data from the IMROZ phase III trial demonstrated Sarclisa (isatuximab), in combination with standard-of-care bortezomib, lenalidomide, and dexamethasone (VRd) followed by Sarclisa-Rd (the IMROZ regimen), significantly reduced the risk of disease progression or death by 40%, compared to VRd followed by Rd in patients with newly-diagnosed multiple myeloma not eligible for transplant.
FDA has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomid, and dexamethasone (D-VRd) for induction and consolidation in patients with newly-diagnosed multiple myeloma who are eligible for an autologous stem cell transplant.
The European Medicines Agency has accepted the marketing authorization application for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex) as a treatment for relapsed or refractory multiple myeloma.
The phase II MagnetisMM-3 study of Elrexfio (elranatamab-bcmm) in patients with heavily pretreated relapsed or refractory multiple myeloma demonstrated a median OS of 24.6 (95% CI, 13.4, NE) months in cohort A (n=123) of the pivotal single arm trial.
At the recent ASCO annual meeting, within hematologic malignancies, therapies for multiple myeloma stole the show, comme d’habitude.
Data from the IMROZ phase III trial demonstrated Sarclisa (isatuximab) in combination with standard-of-care bortezomib, lenalidomide and dexamethasone followed by Sarclisa-Rd (the IMROZ regimen) significantly reduced the risk of disease progression or death by 40%, compared to VRd followed by Rd in patients with newly diagnosed multiple myeloma not eligible for transplant.
In a unanimous vote, the FDA Oncologic Drugs Advisory Committee advised the agency to accept the metric of “minimal residual disease,” or MRD, as a basis for accelerated approvals of therapies in all settings of multiple myeloma.
