Six members of the FDA Oncologic Drugs Advisory Committee received conflict of interest waivers to participate in the agency’s upcoming three-day meeting to review the accelerated approval of six checkpoint inhibitor indications after the three cancer immunotherapies at issue failed to confirm clinical benefit in post-market trials raising questions about whether industry influence may heavily factor in the committee’s decision making.
Conflicts Galore: Upcoming Accelerated Approval Cancer Panel Includes Many Industry Relationships
US FDA issued six conflict-of-interest waivers for the Oncologic Drugs Advisory Committee’s three-day panel to consider whether indications for three immunotherapies – Tecentriq, Keytruda and Opdivo – should be withdrawn after failed clinical outcomes studies.
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
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Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
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March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
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Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.