FDA Issues CRL for Subcutaneous Amivantamab Due to Manufacturing Facility Inspection Findings

Dec 18, 2024 11:00 CST Updated 11:00

Johnson & Johnson

Medical Device R&D and Manufacturer

December 18,Johnson & Johnson announced,The U.S. FDA has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of the subcutaneous injection version of amivantamab for the treatment of patients with epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC).。

Refusal of approval is related to the on-site results of the pre-approval inspection of manufacturing plant standards.The CRL is not related to the efficacy and safety data submitted in the product formula or regulatory application, and the FDA has not requested any additional clinical studies. The currently approved intravenous formulation of RYBREVANT® (amivantamab-vmjw) is not affected by the CRL.

Amivantamab-vmjw (Rybrevant®) is a humanizedEGFR/MET Bispecific AntibodyIn May 2021, it received accelerated approval from the U.S. FDA for the treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 20 insertion mutations as detected by an FDA-approved test and whose disease has progressed on or after platinum-based chemotherapy.

Johnson & Johnson submitted a Biologics License Application (BLA) for subcutaneous Rybrevant in June. In August, the FDA granted it Priority Review. The BLA is based on Phase 3 PALOMA-3 trial data, which was presented at the American Society of Clinical Oncology meeting in May. The subcutaneous formulation is a combination of the monoclonal antibody amivantamab and recombinant human hyaluronidase enzyme.

In August 2024, the FDA granted priority review to the BLA for SC amivantamab in NSCLC patients with EGFR exon 19 deletion (ex19del) or L858R substitution mutations.RYBREVANT® has been approved in more than 60 countries worldwide.

Yusri Elsayed, Global Therapeutic Area Head of Oncology and Innovative Medicine at Johnson & Johnson, said in a press release, "We are working closely with the FDA to bring the subcutaneous version of amivantamab to patients as soon as possible, and we are confident in the path to resolving the issue." Johnson & Johnson added that no issues related to the drug's formulation, efficacy, or safety were identified, and the FDA has not requested additional trials.

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