Talvey
Oncology· 1706 cited findings· 2 source documents
Company: Johnson & Johnson →
What the regulatory reviews say
Talvey (talquetamab-tgvs) is a drug for which a Biologics License Application (BLA) was submitted on December 9, 2022, and received Priority review. The BLA was reviewed and completed on August 1, 2023, with a PDUFA goal date of August 9, 2023. The application number is 761342.
In terms of efficacy, the Overall Response Rate (ORR) for the 0.4 mg/kg weekly regimen was 73%, with a Median Duration of Response (DOR) of 9.5 months. For the 0.8 mg/kg biweekly regimen, the ORR was 73.6%, though the Median Duration of Response was not estimable. Among responders, 85% maintained their response for at least 9 months. The overall response (sCR + CR + VGPR + PR) for the 0.4 mg/kg weekly subcutaneous regimen was 72.7%, with 58.0% achieving VGPR or better (sCR + CR + VGPR) and 28.7% achieving CR or better (sCR + CR).
Safety data from a primary safety population of 339 patients showed a 76% incidence of Cytokine Release Syndrome (CRS), with 57% being Grade 1, 17% Grade 2, and 1.5% Grade 3. Neurologic toxicity occurred in 55% of patients, with 5% experiencing Grade 3 or 4 events. Common neurologic adverse events included headache (20%) and encephalopathy (15%). The duration of exposure for the 0.8 mg/kg biweekly regimen was 3.7 months.
Key figures — cited to the source page
| Overall Response Rate (ORR) for 0.4 mg/kg weekly regimen | 73% | Johnson & Johnson — Talvey FDA Review, p.27 |
| Median Duration of Response (DOR) for 0.4 mg/kg weekly regimen | 9.5 | Johnson & Johnson — Talvey FDA Review, p.27 |
| Overall Response Rate (ORR) for 0.8 mg/kg biweekly regimen | 73.6% | Johnson & Johnson — Talvey FDA Review, p.27 |
| Incidence of CRS | 76% | Johnson & Johnson — Talvey FDA Review, p.25 |
| Incidence of neurologic toxicity | 55% | Johnson & Johnson — Talvey FDA Review, p.25 |
| Incidence of Grade 3 or 4 neurologic toxicity | 5% | Johnson & Johnson — Talvey FDA Review, p.25 |
| Application Type | BLA – 351(a) Original BLA | Johnson & Johnson — Talvey FDA Review, p.2 |
| Priority | Priority | Johnson & Johnson — Talvey FDA Review, p.2 |
Source documents
Explore the full evidence
All 1706 cited findings for Talvey — searchable, comparable and answerable in plain language — are in the Oncology research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.