Unknown MAH — Rybrevant EMA EPAR variation assessment report (EMEA/H/C/005454, 2021)
Unknown MAH · 2021 · EMA EPAR variation assessment report
Report summary
This report assesses a variation application for Rybrevant (amivantamab) to introduce new subcutaneous (SC) formulations (1600 mg and 2240 mg) for first-line treatment of advanced NSCLC with EGFR Exon 19 deletions or Exon 21 L858R substitution mutations, and monotherapy for advanced NSCLC with activating EGFR Exon 20 insertion mutations after platinum-based therapy failure. The goal is to improve patient experience, reduce infusion-related reactions, and decrease healthcare resource utilization. The report details the manufacturing process, characterization, and stability of the active substance and finished product, including the use of recombinant human hyaluronidase (rHuPH20) for SC administration. It confirms an 18-month shelf-life for the SC product and acceptable manufacturing processes. Pharmacokinetic data from PALOMA studies demonstrate non-inferiority of the SC formulation compared to the intravenous formulation in NSCLC patients.
Key findings — cited to the page
| number of participants in PALOMA-3 (SC arm) for PK evaluable dataset | 206 | PALOMA-3 · p.40 |
| number of participants in PALOMA-3 (IV arm) for PK evaluable dataset | 208 | PALOMA-3 · p.40 |
| geometric mean ratio of Cycle 2 Day 1 Ctrough (SC vs IV) | 1.145 | PALOMA-3 · p.41 |
| 90% CI lower bound for geometric mean ratio of Cycle 2 Day 1 Ctrough (SC vs IV) | 1.040 | PALOMA-3 · p.41 |
| 90% CI upper bound for geometric mean ratio of Cycle 2 Day 1 Ctrough (SC vs IV) | 1.261 | PALOMA-3 · p.41 |
| geometric mean ratio of Cycle 2 AUCD1-D15 (SC vs IV) | 1.032 | PALOMA-3 · p.41 |
| 90% CI lower bound for geometric mean ratio of Cycle 2 AUCD1-D15 (SC vs IV) | 0.976 | PALOMA-3 · p.41 |
| 90% CI upper bound for geometric mean ratio of Cycle 2 AUCD1-D15 (SC vs IV) | 1.090 | PALOMA-3 · p.41 |
| geometric mean ratio of Observed Cycle 4 Day 1 Ctrough (SC vs IV) | 1.427 | PALOMA-3 · p.41 |
| 90% CI lower bound for geometric mean ratio of Observed Cycle 4 Day 1 Ctrough (SC vs IV) | 1.266 | PALOMA-3 · p.41 |
| 90% CI upper bound for geometric mean ratio of Observed Cycle 4 Day 1 Ctrough (SC vs IV) | 1.610 | PALOMA-3 · p.41 |
| shelf-life of amivantamab 160 mg/mL SC finished product | 18 months | · p.23 |
Source: Unknown MAH ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →