J&J Submits BLA For Subcutaneous Amivantamab Combination In EGFR-mutated NSCLC Patients

(RTTNews) - Monday, Johnson & Johnson (JNJ) announced the submission of a Biologics License Application or 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 current approved or submitted indications of intravenous Amivantamab-vmjw or Rybrevant for patients with EGFR-mutated non-small cell lung cancer or NSCLC.

The BLA submission is supported by Phase 3 PALOMA-3 results, which showed a five-fold decrease in infusion-related reactions with the five-minute administration of subcutaneous Amivantamab. Data from the Phase 2 PALOMA-2 study, evaluating subcutaneous Amivantamab in scenarios where IV Amivantamab was previously approved, are also included in the submission.

The company indicated that this BLA submission follows the approval of Rybrevant in combination with chemotherapy as the initial FDA-approved treatment for first-line therapy in NSCLC patients with EGFR exon 20 insertion mutations. Additionally, a positive opinion from the CHMP was obtained for Rybrevant in combination with chemotherapy for the same indication in Europe.