FDA Approves Elrexfio for Relapsed/Refractory Multiple Myeloma
The FDA has granted accelerated approval to elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
Elrexfio is a bispecific antibody that targets BCMA on myeloma cells and CD3 on T cells, bringing them into proximity to promote myeloma cell killing. The approval is based on data from the MagnetisMM-3 trial, which demonstrated a 51% overall response rate and a median duration of response of 13.7 months.
Common side effects include cytokine release syndrome, neutropenia, and infections.
The FDA recommends healthcare professionals monitor patients closely for cytokine release syndrome and manage it appropriately. Elrexfio carries a boxed warning for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome.
The FDA approved epcoritamab-bysp in combination with lenalidomide and rituximab for patients with relapsed or refractory follicular lymphoma and as monotherapy for these patients after two or more lines of systemic therapy.
The FDA based approval of the combination therapy on data from the phase 3 EPCORE FL-1 trial, which included 488 patients with relapsed or refractory follicular lymphoma. All patients had received at least one prior line of systemic therapy, with nearly a quarter (24%) receiving at least two and 17% at least three.
Researchers randomly assigned patients 1:1 to receive lenalidomide (Revlimid; Celgene, Bristol Myers Squibb) and rituximab (Rituxan; Genentech, Biogen), with or without epcoritamab-bysp.
The regimen with epcoritamab-bysp demonstrated superiority in both PFS (HR = 0.21; 95% CI,0.13-0.33) and overall response rate (89% vs 74%) compared with the control arm. Median PFS was not reached (95% CI,21.9-NR) in the epcoritamab-bysp arm vs. 11.2 months (95% CI, 10.5-NR) in the control arm.
Prescribing facts includes boxed warnings for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, which occurred in 24% and 0.8% of patients in the epcoritamab-bysp arm, respectively.Serious adverse reactions occurred in 51% of patients in this arm,with 28% experiencing serious infections.
Recommended dosing for the combination regimen includes subcutaneous administration of epcoritamab-bysp for up to 12 28-day cycles, during which lenalidomide is administered on days 1 to 21 of each cycle and rituximab for five cycles.
Recommended epcoritamab-bysp monotherapy dosing is a three step-up schedule for the first cycle – 0.16 mg on day 1, 0.8 mg on day 8, 3 mg on day 15 and 48 mg on day 22 – with weekly dosing of 48 mg for cycles two and three, followed by 48 mg every 4 weeks for cycles four through 12.
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