SUMMARY

• On December 13th, 2024, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Biologics License Application of subcutaneous (SC) amivantamab in patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). During a standard pre-approval inspection at a manufacturing facility in Johnson & Johnson’s network, the FDA made observations that must be addressed prior to approval, delaying the planned launch timing.
• The CRL is unrelated to the product formulation, or the efficacy and safety data submitted in the regulatory application, and the FDA has not requested any additional clinical studies.
• This CRL will result in a delay to the planned launch timing of SC amivantamab. We’re working closely with the FDA to bring this important subcutaneous treatment to patients as quickly as possible.
• The currently approved intravenous (IV) formulation of RYBREVANT^® is not impacted by the CRL, and patients currently receiving or beginning therapy can proceed. There is no impact to ongoing clinical trials involving IV or SC amivantamab. Additionally, this matter does not impact the availability of LAZCLUZE™.
• For additional information, please refer to the December 16, 2024 press release.

Data on File. Internal Communication; December 2024.