Johnson & Johnson 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.
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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.
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By GlobalDataThe submission follows the recent FDA approval of the intravenous RYBREVANT in combination with chemotherapy for first-line treatment of NSCLC with EGFR exon 20 insertion mutations, based on the Phase III PAPILLON study.
The Committee for Medicinal Products for Human Use (CHMP) in Europe provided a positive opinion for RYBREVANT plus chemotherapy for the same indication.
Johnson & Johnson innovative medicine solid tumours clinical development vice-president Kiran Patel stated: “RYBREVANT administered intravenously is a foundational treatment for patients with EGFR-mutated NSCLC.
“This subcutaneous option, administered in approximately five minutes, is a clinically important advancement that could transform the treatment experience for patients, oncologists and nursing staff. We look forward to working with the FDA and global regulators in the review of these applications.”
In June 2024 the company filed a supplemental new drug application (sNDA) with the US FDA for the use of its HIV-1 therapy, PREZCOBIX (darunavir/cobicistat), in children aged six years and above.
