Johnson & Johnson — Talvey FDA Review (BLA761342, ORIG 1, 2023)
Johnson & Johnson · 2023 · FDA Review (openFDA) · company profile →
Report summary
The FDA's multi-disciplinary review of Johnson & Johnson's Talquetamab-tgvs (Talvey) for relapsed or refractory multiple myeloma supports accelerated approval based on efficacy data from the MonumenTAL-1 trial. Talvey, administered weekly or bi-weekly subcutaneously, demonstrated high overall response rates exceeding 70% in heavily pretreated patients. Nonclinical data and pharmacokinetic analyses were deemed adequate. Key safety concerns include cytokine release syndrome (CRS), neurologic toxicity, and oral/skin toxicities, necessitating a REMS program with a Boxed Warning. Postmarketing requirements include a randomized trial to verify efficacy and safety, and studies to further characterize and mitigate oral toxicity.
Key findings — cited to the page
| Incidence of Grade 2 CRS | 17% | Talquetamab-tgvs · p.25 |
| Incidence of Grade 1 CRS | 57% | Talquetamab-tgvs · p.25 |
| Incidence of Grade 3 CRS | 1.5% | Talquetamab-tgvs · p.25 |
| Incidence of Grade 3 or 4 neurologic toxicity | 5% | Talquetamab-tgvs · p.25 |
| Grade 3 CRS for 0.4 mg/kg Weekly SC | 2.1 % | · p.195 |
| Grade 1 CRS for 0.8 mg/kg Q2W SC | 54.5 % | · p.197 |
| Grade ≥3 Lymphopenia occurrence rate | 79.9 % | Talquetamab-tgvs · p.312 |
| Serious ADRs reported in ≥2% of participants (Sepsis, Any Grade) | 4.4 % | · p.188 |
| CRS (any grade) for 0.4 mg/kg Weekly SC | 79.0 % | · p.195 |
| Serious ADRs reported in ≥2% of participants (Sepsis, Grade 3 or 4) | 3.8 % | · p.188 |
| Grade 2 CRS for 0.4 mg/kg Weekly SC | 14.7 % | · p.195 |
| Serious ADRs reported in ≥2% of participants (Viral infection, Any Grade) | 5.6 % | · p.188 |
Source: Johnson & Johnson ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →