FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma

Regulatory approval: On March 5, 2026, the FDA granted accelerated approval to teclistamab (Tecvayli) in combination with daratumumab hyaluronidase-fihj for adults with relapsed/refractory multiple myeloma after ≥1 prior line including a proteasome inhibitor and an immunomodulatory agent. The decision was supported by the randomized MajesTEC-3 trial, showing a PFS benefit versus investigator’s choice control. The FDA also converted teclistamab monotherapy from accelerated to traditional approval for heavily pretreated disease.

FDA approval (accelerated): teclistamab + daratumumab hyaluronidase-fihj in RRMM

On March 5, 2026, the FDA granted accelerated approval to teclistamab (Tecvayli) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received ≥1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.

The FDA also converted teclistamab monotherapy from accelerated to traditional approval for adults with RRMM after ≥4 prior lines, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody (teclistamab previously received accelerated approval for this indication in 2022).

Key efficacy evidence: MajesTEC-3 (NCT05083169)

MajesTEC-3 was a randomized, open-label, multicenter trial (N=587) comparing teclistamab + daratumumab hyaluronidase-fihj (n=291) vs investigator’s choice control (n=296) of DPd or DVd. The primary endpoint was PFS by independent review (IMWG 2016 criteria).

  • Median PFS: NR (95% CI: NE, NE) vs 18.1 months (95% CI: 14.6–22.8); HR 0.17 (95% CI: 0.12–0.23); p<0.0001.
  • Median OS: NR in both arms; HR 0.46 (95% CI: 0.32–0.65); p<0.0001.

Safety / access

Tecvayli prescribing information includes a Boxed Warning for CRS and neurologic toxicity (including ICANS) and is available only via a REMS (Tecvayli-Talvey REMS). Common adverse reactions in the combination included hypogammaglobulinemia and infections (including COVID-19 and pneumonia), among others.

Review used Project Orbis, RTOR, and the CNPV pilot; partner agencies’ reviews may still be ongoing.

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