has filed a biologics licence application (BLA) with the US Food and Drug Administration (FDA) seeking approval for a new subcutaneous (SC) form of amivantamab for the treatment of patients with non-small cell lung cancer (NSCLC). The company applied a fixed formulation comprising amivantamab and recombinant human hyaluronidase for subcutaneous administration. The gold standard of business intelligence.
It is seeking approval for all currently approved or submitted indications of intravenous (IV) RYBREVANT(amivantamab-vmjw) in NSCLC patients with epidermal growth factor receptor (EGFR) mutations. The BLA submission is based on the results from the open-label, randomised Phase III PALOMA-3 clinical trial in 418 participants. This trial compared the pharmacokinetics, efficacy, and safety of SC amivantamab combined with lazertinib to its intravenous counterpart in advanced or metastatic NSCLC patients.
SC amivantamab demonstrated a comparable overall response rate to intravenous administration in patients with NSCLC harbouring EGFR exon 19 deletion or L858R mutations. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
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