RYBREVANT - Dosage and Administration - Restarting After Prolonged Treatment Interruption

SUMMARY

• RYBREVANT (amivantamab-vmjw) is a low fucose, fully human immunoglobulin G1 (IgG1)-based bispecific antibody with immune cell-directing activity that targets epidermal growth factor receptor (EGFR) mutations and mesenchymal-epithelial transition (MET) mutations and amplifications in non-small cell lung cancer (NSCLC).¹ 
• Clinical judgement should be exercised when considering any dosing interruptions for RYBREVANT. The company does not recommend the use of RYBREVANT in a manner that is inconsistent with the approved labeling.
• Please refer to product labeling for complete dosage and administration information.
• In the ongoing phase 1 CHRYSALIS study, the occurrence of infusion-related reactions (IRRs) was evaluated in 380 patients who received RYBREVANT monotherapy at the recommended phase 2 dose (RP2D) as of the March 30, 2021, data cutoff. Most IRRs (90%) occurred on cycle (C)1, day (D)1, and the median time to first IRR onset during C1D1 was 60 minutes. The first-infusion IRRs did not compromise the ability to administer subsequent infusions and continue treatment.²
• When resuming RYBREVANT after a prolonged dose hold lasting over a month, consideration may be given to reinitiating with weekly dosing using the 2-day split dose the patient received on C1D1 and C1D2.²

Clinical data

CHRYSALIS Study

CHRYSALIS (NCT02609776) is an ongoing, phase 1, open-label, multicenter, dose-escalation and dose-expansion study evaluating the safety, efficacy, and pharmacokinetics of RYBREVANT as monotherapy and in combination with other therapies in patients with advanced NSCLC harboring EGFR mutations who had disease progression during or after previous standard of care (SOC) treatment.³

The occurrence of IRRs was evaluated in 380 patients who received RYBREVANT monotherapy at the RP2D as of the March 30, 2021 data cutoff. Overall, 279 IRRs were reported in 256 (67%) patients. A majority of the 279 IRRs (97%) were grade 1 or 2; grade 3 and 4 IRRs occurred in 7 and 1 patients, respectively. Most IRRs (90%) occurred on C1D1, and the median time to first IRR onset during C1D1 was 60 minutes. The firstinfusion IRRs did not compromise the ability to administer subsequent infusions and continue treatment. Close monitoring for IRR with the initial RYBREVANT dose and early intervention at first IRR signs/symptoms should be part of routine RYBREVANT administration. When resuming RYBREVANT after a prolonged dose hold lasting over a month, consideration may be given to re-initiating with weekly dosing using the 2-day split dose the patient received on C1D1 and C1D2.²

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 16 January 2026.