FDA Gives CRL to J&J's BLA for Subcutaneous Rybrevant in NSCLC

Johnson & Johnson (JNJ) announced that the FDA has issued a complete response letter (“CRL”) to its biologics license application (“BLA”) seeking approval for the subcutaneous (“SC”) formulation of its EGFR/MET inhibitor, Rybrevant, for EGFR-mutated non-small cell lung cancer (“NSCLC”).Rybrevant is currently approved as an intravenous (IV) formulation as a combination therapy for treating NSCLC across different lines of treatment and various mutations.The BLA is seeking approval for a fixed combination of S ...