FDA Gives CRL to J&J's BLA for Subcutaneous Rybrevant in NSCLC
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The FDA has issued a complete response letter (CRL) to Johnson & Johnson's Biologics License Application (BLA) for the subcutaneous formulation of Rybrevant, intended for treating EGFR-mutated non-small cell lung cancer (NSCLC).
December 17, 2024 | 2:45 pm
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Johnson & Johnson received a CRL from the FDA for its BLA for the subcutaneous version of Rybrevant, which may delay its approval and market entry.
The FDA's CRL indicates that the application for the subcutaneous formulation of Rybrevant is not ready for approval in its current form. This could delay the product's market entry, affecting J&J's potential revenue from this formulation. The news is highly relevant and important for J&J investors as it directly impacts the company's product pipeline and potential earnings.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100