Update on U.S. Regulatory Review of Subcutaneous Amivantamab
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of subcutaneous amivantamab.
This fixed combination, which includes recombinant human hyaluronidase for subcutaneous administration, is being reviewed as a treatment for non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
The CRL is linked to observations made during a routine pre-approval inspection at a manufacturing facility and is not related to the product’s formulation, nor to the submitted efficacy and safety data. The FDA has not requested any additional clinical studies.
The currently approved intravenous (IV) formulation of RYBREVANT® (amivantamab-vmjw) remains unaffected by the CRL.
“We are committed to working closely with the FDA to resolve the issues and bring SC amivantamab to patients as soon as possible, We remain confident in the strong efficacy and safety profile of RYBREVANT and look forward to expanding treatment options for patients with EGFR-mutated lung cancer.”– Dr. Yusri Elsayed, Global Therapeutic Area Head, Oncology, Innovative Medicine, Johnson & Johnson.
The BLA submission is based on data from the Phase 3 PALOMA-3 study, which was presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology. This submission follows the FDA’s August 2024 grant of Priority Review for SC amivantamab in NSCLC patients with EGFR exon 19 deletions (ex19del) or L858R substitutions.
About the PALOMA-3 Study
The Phase 3 PALOMA-3 study evaluated the pharmacokinetics, efficacy, and safety of subcutaneous amivantamab combined with lazertinib compared to IV amivantamab and LAZCLUZE™ (lazertinib) in patients with advanced or metastatic EGFR-mutated NSCLC. Preliminary data from the study demonstrated favorable trends in overall survival compared to osimertinib, underscoring the potential of this new formulation.
About RYBREVANT®
IV RYBREVANT® (amivantamab-vmjw) is a fully human bispecific antibody targeting EGFR and MET, approved for the treatment of EGFR-mutated advanced or metastatic NSCLC. The subcutaneous formulation of amivantamab, co-formulated with recombinant human hyaluronidase PH20, leverages Halozyme’s ENHANZE® technology to improve delivery and patient experience.
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