J&J: FDA delays approval of Rybrevant in NSCLC

(CercleFinance.com) - Johnson & Johnson announces that it has received a Complete Response Letter (CRL) from the U.
S. Food and Drug Administration (FDA) following its Biologics License Application (BLA) for the subcutaneous fixed combination of amivantamab and recombinant human hyaluronidase for patients with EGFR-mutated non-small cell lung cancer (NSCLC).

The LRC refers to observations made during a standard inspection of a manufacturing facility, and does not call into question the product's formulation or its efficacy and safety data.

The approved intravenous formulation of Rybrevant (amivantamab-vmjw) is therefore unaffected.

Johnson & Johnson remains confident that the situation will be resolved quickly.

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