The US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) felt that Daiichi Sankyo Co. Ltd.'s acute myeloid leukemia candidate quizartinib is not quite ready for market in voting against approval by an 8-3 margin at a 14 May meeting. But panelists felt there is a path forward for the drug if the sponsor can more adequately define its efficacy in another trial.
Quizartinib Looks Like A Good Drug, ODAC Says, But Needs Another Efficacy Trial Before Approval
US FDA's Oncologic Drugs Advisory Committee voted 8-3 against approval for Daiichi's quizartinib, although panelists felt the acute myeloid leukemia candidate would be approvable with another trial to better characterize its efficacy.
More from US FDA Performance Tracker
More from Regulatory Trackers
• By
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.
• By
The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.
• By
The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.