US FDA Approves Subcutaneous Amivantamab for EGFR-mutated NSCLC

The US FDA has approved a subcutaneous formulation of amivantamab in combination with hyaluronidase-ipuj for the treatment of adult patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). This approval marks the first subcutaneously administered therapy authorized across all indications previously approved for intravenous (IV) amivantamab-vmjw.

Indications : Amivantamab and hyaluronidase-ipuj combination therapy is approved for use in the following settings: In combination with lazertinib for the first-line treatment of patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations. In combination with carboplatin and pemetrexed for patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or…