Unknown MAH — Rybrevant EMA EPAR variation assessment report (EMEA/H/C/005454, 2021)
Johnson & Johnson · 2021 · EMA EPAR variation assessment report · company profile →
Report summary
The CHMP recommended extending Rybrevant's marketing authorization, approving new 2400 mg and 3520 mg subcutaneous (SC) strengths for all approved indications. This decision follows a comprehensive assessment of new Q3W and Q4W SC dosing regimens. Manufacturing process changes at SBL Plant 4A, including scale-up and new analytical methods, were validated. Pharmacokinetic (PK) bridging studies (PALOMA, PALOMA-2) demonstrated comparable exposure metrics between the new SC regimens and existing intravenous (IV) regimens, supporting the extrapolation of efficacy and safety. Clinical data from PALOMA-2, evaluating amivantamab in combination with lazertinib or carboplatin/pemetrexed for EGFR-mutated NSCLC, showed consistent efficacy and safety profiles. The overall benefit-risk balance for the proposed SC posologies is considered positive, with updates to the Summary of Product Characteristics addressing identified risks.
Key findings — cited to the page
| Grade 5 AEs (Amivantamab + Carboplatin + Pemetrexed, Total) | 7 (4.9%) | PALOMA-2 Cohort 2 and 3b · p.73 |
| Rash (all grades) (Amivantamab SC Q4W + Lazertinib) | 70 (90.9%) | PALOMA-2 Cohort 5 · p.76 |
| Grade 5 AEs (Amivantamab + Lazertinib) | 2 (2.6%) | PALOMA-2 Cohort 5 · p.72 |
| Grade 4 AEs (Amivantamab + Carboplatin + Pemetrexed, Total) | 20 (14.0%) | PALOMA-2 Cohort 2 and 3b · p.73 |
| Grade 3-4 treatment-emergent adverse drug reaction (Amivantamab SC Q4W + Lazertinib) | 27 (35.1%) | PALOMA-2 Cohort 5 · p.76 |
| Grade 3-4 treatment-emergent adverse drug reaction (Pooled SC and IV Amivantamab + Lazertinib) | 397 (47.9%) | Pooled SC and IV Amivantamab + Lazertinib · p.76 |
| Grade 3 AEs (Amivantamab + Lazertinib) | 32 (41.6%) | PALOMA-2 Cohort 5 · p.72 |
| Grade 4 AEs (Amivantamab + Lazertinib) | 2 (2.6%) | PALOMA-2 Cohort 5 · p.72 |
| Subjects with 1 or more toxicity grade 3 or higher AEs (Amivantamab + Lazertinib) | 36 (46.8%) | PALOMA-2 Cohort 5 · p.72 |
| Grade 3 AEs (Amivantamab + Carboplatin + Pemetrexed, Total) | 73 (51.0%) | PALOMA-2 Cohort 2 and 3b · p.73 |
| Subjects with 1 or more toxicity grade 3 or higher AEs (Amivantamab + Carboplatin + Pemetrexed, Total) | 100 (69.9%) | PALOMA-2 Cohort 2 and 3b · p.74 |
| Rash (Grade 3-4) (Amivantamab SC Q4W + Lazertinib) | 15 (19.5%) | PALOMA-2 Cohort 5 · p.76 |
Source: Johnson & Johnson ↗ · 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 →