Johnson & Johnson (J&J, NYSE: JNJ) has announced that the Biologics License Application (BLA) filed with the US FDA for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) has received a complete response letter (CRL). The application sought approval for the treatment of patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. The rejection is attributed to observations from a standard pre-approval inspection at a manufacturing facility, rather than issues with the product formulation or the efficacy and safety data submitted, according to the company. The currently approved intravenous (IV) formulation of Rybrevant (amivantamab-vmjw) remains unaffected by this decision.
Amivantamab’s Mechanism and Approval History
Amivantamab is a fully-human EGFR-MET bispecific antibody that targets tumors with activating and resistance EGFR mutations and MET mutations and amplifications, while also harnessing the immune system. It was first approved in the US in May 2021 for the treatment of NSCLC with EGFR exon 20 insertion mutations.
Market Filing Progression in China
In China, a first market filing for amivantamab was made in October 2023, indicated for the treatment of advanced or metastatic EGFR exon 20 mutant NSCLC. This was followed by a second filing in December 2023, presumably for use in combination with chemotherapy in EGFR mutant NSCLC patients with disease progression during or after third-generation TKIs treatment. The market filing for SC amivantamab was accepted for review in China in September of this year.-Fineline Info & Tech
