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.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The 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.