RYBREVANT

批准信原文要点

This Prior Approval sBLA provides for revisions to the Dosage and Administration section of the U.S. Prescribing Information labeling, in addition to updates to the Warnings and Precautions, Adverse Reactions, and Patient Counseling Information sections, to include recommended prophylactic and concomitant medications to reduce the risk of dermatologic adverse reactions.

批准信原文要点

This Prior Approval sBLA provides for updates to the U.S. Prescribing Information label, including skin ulcer as a clinically relevant adverse reaction to the Adverse Reactions (6.1 Clinical Trials Experience) section.

批准信原文要点

We also refer to our approval letter dated September 3, 2025, which contained the following error: In the Highlights of the U.S. Prescribing Information labeling, an incorrect date of 08/2025 appears in both the “Recent Major Changes” and “Revised:” date sections. It should be 09/2025. The corrected action letter incorporates the correction of the error. The effective action date will remain September 3, 2025. This Prior Approval sBLA provides for updates to the Dosage and Administration (2.5 Recommended Premedications) section of the Rybrevant U.S. Prescribing Information labeling, to include additional doses of dexamethasone prior to cycle 1 of amivantamab-vmjw to reduce the risk of infusion-related reactions.

批准信原文要点

This Prior Approval sBLA provides for updated final overall survival analysis, in fulfillment of the August 19, 2024, Post-Marketing Commitment 4680-2, based on results from the MARIPOSA trial.

批准信原文要点

This Prior Approval supplemental biologics application provides for updates to the U.S. Prescribing Information to include anaphylaxis as an adverse reaction in Sections 2 Dosage and Administration (2.6 Dosage Modifications for Adverse Reactions), 5 Warnings and Precautions (5.1 Infusion-Related Reactions), 6 Adverse Reactions (6.2 Postmarketing Experience), and 17 Patient Counseling Information.

批准信原文要点

This Prior Approval sBLA provides for a new indication for Rybrevant (amivantamab-vmjw), in combination with carboplatin and pemetrexed, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.

批准信原文要点

This Prior Approval sBLA provides for amivantamab in combination with lazertinib for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.

批准信原文要点

This Prior Approval supplemental biologics license application provides for: • A new indication of amivantamab in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test. • Revisions to US Prescribing Information (USPI) to support the fulfillment of the subpart E postmarketing requirement and traditional approval of amivantamab as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

批准信原文要点

This Prior Approval sBLA provides for revisions to the Dosage and Administration (2.1 Patient Selection based on data related to PMC 4070-4) and Clinical Studies (14) sections of the U.S. Prescribing Information, clarifying data related to plasma testing.

批准信原文要点

This “Changes Being Effected” supplemental biologics application provides for revisions to the DOSAGE AND ADMINISTRATION, Recommended Dosage subsection (2.2) to clarify the schedule of administration