The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for a fixed combination of Rybrevant (amivantamab) and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) in non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations.
This CRL is related to observations as part of a standard pre-approval inspection at a manufacturing facility, according to Johnson & Johnson (NYSE: JNJ), the company developing Rybrevant.
We believe strongly in the robust efficacy and safety of Rybrevant
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