On Monday, Johnson & Johnson (JNJ) announced the submission of a Biologics License Application (BLA) to the FDA for a subcutaneous administration of a fixed combination of Amivantamab and recombinant human hyaluronidase.
This subcutaneous administration of Amivantamab covers all currently approved or submitted indications of intravenous Amivantamab-vmjw, also known as Rybrevant, for patients with EGFR-mutated non-small cell lung cancer (NSCLC).
The BLA submission is underpinned by Phase 3 PALOMA-3 results, which demonstrated a five-fold reduction in infusion-related reactions with the five-minute administration of subcutaneous Amivantamab. Additionally, data from the Phase 2 PALOMA-2 study, which evaluated subcutaneous Amivantamab in clinical scenarios where intravenous Amivantamab had previously been approved, is also part of the submission.
The company noted that this BLA submission follows the approval of Rybrevant combined with chemotherapy as the first FDA-approved treatment for first-line therapy in NSCLC patients with EGFR exon 20 insertion mutations. Furthermore, a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) was received for Rybrevant in combination with chemotherapy for the same indication in Europe.
