Rybrevant Adverse Reactions

Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of amivantamab based on the comprehensive assessment of the available adverse event information. A causal relationship with amivantamab cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of RYBREVANT was evaluated in Study EDI1001, which included 153 patients with locally advanced or metastatic NSCLC with EGFR Exon 20 mutations whose disease has progressed on or after platinum-based chemotherapy. Patients received RYBREVANT 1050 mg (for patients <80 kg) or 1400 mg (for patients ≥80 kg) by intravenous infusion once weekly for 4 weeks, then every 2 weeks starting at Week 5 until disease progression or unacceptable toxicity. The median treatment duration was 5.6 months (range: 0.0 to 23.9 months).
The most common adverse reactions ≥20% were rash, IRR, nail toxicity, hypoalbuminemia, fatigue, edema, stomatitis, nausea, constipation, dry skin, and alanine aminotransferase increased. Serious adverse reactions in >1% of patients included ILD, diarrhea, IRR, and rash. Five percent of patients discontinued RYBREVANT due to adverse reactions. The most frequent adverse reactions leading to treatment discontinuation were IRR and ILD. (See Table 8.)

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Adverse reactions occurring in <10% of RYBREVANT-treated patients with NSCLC Exon 20 insertion mutations in Study EDI1001 are summarized in Table 9. (See Table 9.)

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