EU regulators recommend revoking marketing authorization for Amgen's Tavneos due to data integrity concerns in the ADVOCATE trial, with no new EU patients to start treatment and existing patients advised to switch to alternatives.
EMA's CHMP concluded that Tavneos' benefits no longer outweigh its risks, citing unreliable trial data and breaches of good clinical practice.
The recommendation follows prior FDA concerns and a similar proposal to withdraw U.S. approval, with both agencies citing unreliable trial data and potential liver injury risks.
Sources:
EMA recommends revoking marketing authorisation for Tavneos
CHMP joins FDA in challenging Tavneos' approval basis - BioCentury
[PDF] ReferralN otifications@ema.europa.eu
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