FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma
Regulatory approval: On Aug 9, 2023, the FDA granted accelerated approval to talquetamab-tgvs (Talvey) for adults with relapsed or refractory multiple myeloma after at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Approval was supported by the single-arm MonumenTAL-1 study, with ORR ~73% across two dosing schedules and median DOR 9.5 months (weekly dose) or not estimable (biweekly dose).
FDA accelerated approval (Aug 9, 2023)
The FDA granted accelerated approval to talquetamab-tgvs (Talvey; Janssen Biotech, Inc.) for adults with relapsed or refractory multiple myeloma who have received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Evidence base
Efficacy was evaluated in MMY1001 (MonumenTAL-1; NCT03399799, NCT4634552), a single-arm, open-label, multicenter study including 187 patients with ≥4 prior systemic therapies. Patients received either:
- 0.4 mg/kg SC weekly, after two step-up doses in week 1, or
- 0.8 mg/kg SC every 2 weeks, after three step-up doses, until progression or unacceptable toxicity.
Primary outcomes were ORR and DOR by an Independent Review Committee using IMWG criteria. Results:
- 0.4 mg/kg weekly (n=100): ORR 73% (95% CI 63.2–81.4); median DOR 9.5 months (95% CI 6.5–not estimable).
- 0.8 mg/kg q2w (n=87): ORR 73.6% (95% CI 63–82.4); median DOR not estimable. An estimated 85% of responders maintained response for ≥9 months.
Safety and access
Label includes a Boxed Warning for CRS and neurologic toxicity (including ICANS); talquetamab-tgvs is available only through the Tecvayli–Talvey REMS.
Regulatory context
Review occurred under Project Orbis with collaboration from Australia’s TGA and Switzerland’s Swissmedic; reviews at other agencies were ongoing at the time of the FDA decision.