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    FDA Medical and Team Reviews for TUKYSA SUPPL-4 Approval 01/19/2023

    FDA Medical and Team Reviews for TUKYSA SUPPL-4 Approval 01/19/2023

    $69.00 USD
    $69.00 USD
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    Original Request:  I would like the medical review and cross-discipline team reviews for the following approval: TUKYSA (tucatinib, Seagen Inc.) SUPPL-4, approval dated January 19, 2023, in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy (approval press release here) Please provide the documents electronically if possible.
    Tags: Pharma, NDA, 2023
    • Status: Pending Fast-Track Request
    • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

    NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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