FDA Rejects Subcutaneous Version of J&J’s Lung Cancer Drug Rybrevant Due to Manufacturing Concerns

FDA Rejection:
The FDA issued a Complete Response Letter (CRL) to Johnson & Johnson (J&J) for the subcutaneous version of Rybrevant (amivantamab), a drug used to treat non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations14.

Manufacturing Issues:
The rejection was due to issues found during a pre-approval inspection at a manufacturing facility, not related to the drug’s safety, efficacy, or formulation14.

No Additional Clinical Studies Required:
The FDA did not request any additional clinical studies, indicating that the issues are solely related to manufacturing14.

Impact on Current Approval:
The rejection does not affect the currently approved intravenous (IV) version of Rybrevant14.

J&J’s Response:
J&J stated that they are working closely with the FDA to resolve the issues and are confident in their path to resolution14.

Clinical Trial Results:
The phase 3 PALOMA-3 trial showed that the subcutaneous formulation of amivantamab was noninferior to the IV version, offering greater treatment convenience for patients4.

Market Impact:
The subcutaneous version of Rybrevant is crucial for J&J to bolster sales of the product, which is expected to become a $5 billion drug3.

Sources:

1. https://www.pharmamanufacturing.com/industry-news/news/55250089/fda-rejects-jjs-injectable-version-of-lung-cancer-drug-rybrevant-cites-manufacturing-issues

3. https://www.oncologypipeline.com/apexonco/fda-knocks-back-jjs-subcutaneous-rybrevant

4. https://www.ajmc.com/view/fda-rejects-subcutaneous-amivantamab-for-nsclc-over-manufacturing-concerns