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Updated: Nov 9, 2025

Monitoring PD-1-Blocking Antibodies Bound to T Cells Derived from a Drop of Peripheral Blood
06:07

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Immunotherapy Withdrawals Put Spotlight on Accelerated Approval

    Cancer Discovery
    |April 17, 2021
    PubMed

    Insights

    The FDA

    Area of Science:

    • Oncology
    • Drug Regulation
    • Immunotherapy

    Background:

    • The FDA's Accelerated Approval program allows early drug approval based on surrogate endpoints.
    • Checkpoint inhibitors have shown promise in early cancer trials but require confirmatory survival data.

    Discussion:

    • Four drug companies are withdrawing indications for checkpoint inhibitors due to lack of demonstrated survival benefit.
    • The FDA's Oncologic Drugs Advisory Committee will review six more immunotherapy indications for potential nullification.

    Key Insights:

    • Confirmatory trials are crucial for validating accelerated approvals of cancer immunotherapies.
    • The scrutiny highlights challenges in balancing rapid access to novel treatments with robust efficacy evidence.

    Outlook:

    • Future regulatory decisions may impact the approval pathways for immunotherapies.
    • Continued evaluation of post-market data is essential for ensuring patient benefit and drug safety.

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