FDA D.I.S.C.O. Burst Edition: FDA approvals of Talvey (talquetamab-tgvs) for relapsed or refractory multiple myeloma, and Elrexfio (elranatamab-bcmm) for relapsed or refractory multiple myeloma
Regulatory approval: The FDA granted accelerated approval to talquetamab-tgvs (Talvey) on Aug 9, 2023, and to elranatamab-bcmm (Elrexfio) on Aug 14, 2023, for adults with relapsed or refractory multiple myeloma after ≥4 prior lines including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Both labels carry Boxed Warnings for cytokine release syndrome (CRS) and neurologic toxicity/ICANS and are subject to REMS programs.
FDA D.I.S.C.O. Burst Edition: accelerated approvals in relapsed/refractory multiple myeloma (regulatory approval)
Talquetamab-tgvs (Talvey) received FDA accelerated approval on Aug 9, 2023 for adults with relapsed or refractory multiple myeloma after ≥4 prior lines including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody.
Evidence base: MMY1001, single-arm, open-label, multicenter (n=187). Dosing: 0.4 mg/kg SC weekly (after two step-up doses) or 0.8 mg/kg SC every 2 weeks (after three step-up doses) until progression/toxicity. Primary outcomes: overall response rate (ORR) and duration of response (DOR) by Independent Review Committee (IMWG criteria). ORR was 73% (0.4 mg/kg weekly; n=100; median DOR 9.5 months) and 73.6% (0.8 mg/kg q2w; n=87; median DOR not estimable); 85% of responders were estimated to maintain response ≥9 months.
Safety/controls: Boxed Warning for life-threatening or fatal CRS and neurologic toxicity (including ICANS); available only through Tecvayli-Talvey REMS. Review conducted under Project Orbis; other agencies’ reviews were ongoing.
Elranatamab-bcmm (Elrexfio) received FDA accelerated approval on Aug 14, 2023 for the same post–≥4-line setting.
Evidence base: MagnetisMM-3, open-label, single-arm, multicenter. Primary efficacy population: 97 patients naïve to prior BCMA-directed therapy; ORR 57.7%. With 11.1 months median follow-up among responders, median DOR was not reached; DOR rates were 90.4% at 6 months and 82.3% at 9 months.
Safety/controls: Boxed Warning for CRS and neurologic toxicity/ICANS; at recommended dose, CRS 58%, neurologic toxicity 59%, ICANS 3.3%; Grade 3 CRS 0.5%, Grade 3–4 neurologic toxicity 7%. Available only through ELREXFIO REMS.