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Drugs to Watch – Regulatory Focus – Talvey
A first-in-class multiple myeloma drug wins accelerated approval
Talvey™ (talquetamab) is a first-in-class bispecific antibody targeted to CD3 and GPRC5D for treatment of multiple myeloma (MM). In August 2023, the FDA granted accelerated approval to talquetamab for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received ≥4 prior lines of therapy. It addresses a significant unmet need for new options that offer better disease control, more substantial responses, and improved long-term outcomes.
This report explores:
- Disease and competitive landscape
- Regulatory strategy (e.g., which pathways to pursue in key markets)
- Key areas of regulatory focus, such as safety concerns, pharmacovigilance, use in specific populations and effectiveness
- Outstanding safety and efficacy concerns
