*June 2024*
Highlights
- The FDA has received a biologics license application (BLA) submission for amivantamab-vmjw (Rybrevant) and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab).
- The submission is for all currently approved or submitted indications of intravenous amivantamab in select patients with non–small cell lung cancer (NSCLC).
- Data from the phase 3 PALOMA-3 study (NCT05388669) support the BLA submission.
A BLA for a fixed combination of amivantamab with recombinant human hyaluronidase for SC amivantamab has been submitted to the FDA for all currently approved or submitted indications of IV amivantamab in certain patients with NSCLC.1
The BLA submission is supported by data from the phase 3 PALOMA-3 study in which SC amivantamab demonstrated comparable overall response rates (ORR) to IV administration in patients with NSCLC with EGFR exon 19 deletion or L858R mutations. Further, amivantamab given SC also led to a significantly shorter administration time and a 5-fold reduction in infusion-related reactions.
Longer overall survival (OS), progression-free survival (PFS), and duration of response (DOR) was also seen with SC amivantamab, according to findings presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology. Read more.
