FDA has received a Biologics License Application (BLA) from Johnson & Johnson for subcutaneous amivantamab, a new formulation of the drug for the treatment of non-small cell lung cancer (NSCLC).
The submission included data from a PALOMA-3 trial that showed subcutaneous amivantamab offered significant promise for NSCLC patients compared to the intravenous (IV) version, RYBREVANT®.
Kiran Patel, VP, of Clinical Development, Solid Tumors, Johnson & Johnson, emphasized that “RYBREVANT administered intravenously is a foundational treatment for patients with EGFR-mutated NSCLC.
He acknowledged the significant advancement of the subcutaneous amivantamab, administered in approximately five minutes, as transformative for the treatment experience.
The FDA will thoroughly evaluate the BLA data to determine the safety and efficacy of subcutaneous amivantamab for treating NSCLC.
Additionally, the FDA stated that amivantamab would only be approved if the benefits outweigh the risks for NSCLC patients.
Source: Subcutaneous amivantamab Biologics License Application submitted to U.S. FDA for patients with EGFR-mutated non-small cell lung cancer
https://www.prnewswire.com/news-releases/subcutaneous-amivantamab-biologics-license-application-submitted-to-us-fda-for-patients-with-egfr-mutated-non-small-cell-lung-cancer-302173613.html
