BRAFTOVI

批准信原文要点

This supplemental application proposes to add a new indication for Braftovi (encorafenib) and updates to the Prescribing Information and Medication Guide based upon the results from Cohort 3 of Study C4221015 (BREAKWATER): BRAFTOVI, in combination with cetuximab and fluorouracil- based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-authorized test.

批准信原文要点

This Prior Approval supplemental new drug application provides for updates to the Braftovi (encorafenib) Prescribing Information (PI), and the Medication Guide, with data supporting the proposed indication of Braftovi (encorafenib) in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation.

批准信原文要点

This Prior Approval sNDA provides for updated overall response rate and duration of response data to Section 14 (Clinical Studies) of the BRAFTOVI United States Prescribing Information labeling, based on results from clinical study PHAROS (C4221008/ARRAY-818-202)… associated with postmarketing commitment (PMC) 4528-1.

批准信原文要点

This "Prior Approval" sNDA provides for the new indication of Braftovi in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test.

批准信原文要点

This Prior Approval supplemental new drug application provides for revisions to the US Prescribing Information under Section 14 (Clinical Data) based on a final analysis from Study C4221004 COLUMBUS (CMEK162B2301) and associated with postmarketing commitment (PMC) 3440-3. In addition, Section 6.1 (Clinical Trials Experience) was revised to include “photosensitivity” as an adverse reaction.

批准信原文要点

This Prior Approval sNDA provides for revisions to the DRUG INTERACTIONS and CLINICAL PHARMACOLOGY sections of the Braftovi United States Prescribing Information (USPI). FULFILLMENT OF POSTMARKETING COMMITMENTS … 3440-1 Conduct a clinical pharmacokinetic trial to evaluate the effect of repeat doses of a moderate CYP3A4 inducer on the repeat dose pharmacokinetics of encorafenib…

批准信原文要点

This Prior Approval supplemental new drug application provides for a new indication for encorafenib, in combination with binimetinib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation, as detected by an FDA-approved test.

批准信原文要点

This supplemental application provides for updates to the US Prescribing Information (PI) in Section 7.2 Effect of BRAFTOVI on Other Drugs and Section 12.3 Pharmacokinetics, to add a caution statement for when encorafenib is co-administered with substrates of OATP1B1, OATP1B3,…

批准信原文要点

This Prior Approval supplemental new drug application provides for a new indication for Braftovi, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

批准信原文要点

This Prior Approval supplemental new drug application provides for modifications to Table 1 entitled Recommended Dose Reductions with BRAFTOVI in the DOSAGE AND ADMINISTRATION, Dose Modifications for Adverse Reactions (2.3) subsection and to the Dose Modifications for Coadministration with Strong or Moderate CYP3A4 Inhibitors (2.4) subsection, to include the addition of a new Table 3 entitled “Recommended Dose Reductions for BRAFTOVI for coadministration with Strong or Moderate CYP3A4 Inhibitors” to reflect the removal of the 50 mg capsule dosage form from DOSAGE FORM AND STRENGTHS (3) for encorafenib in combination with binimetinib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation, as detected by an FDA-approved test.

批准信原文要点

This Prior Approval supplemental new drug application provides for an update to the Clinical Studies section (14) of the U.S. prescribing information to include updated overall survival (OS) data from Part 1 of COLUMBUS trial (Study CMEK162B2301).