2023-04-21 11:32:43 ET
- The US FDA has extended by three months its review of Daiichi Sankyo's ( OTCPK:DSKYF ) NDA for quizartinib for newly diagnosed acute myeloid leukemia (AML).
- The new agency action date is July 24.
- The reason for the extra time is that the agency needs to review changes to the proposed Risk Evaluation and Mitigation Strategies (REMS) for the drug. No new efficacy or safety data is being requested.
- The indication for quizartinib is in combination with chemotherapy for AML patients who are FLT3-ITD positive.
- In March, Daiichi Sankyo ( OTCPK:DSNKY ) signed a deal with Belgium-based Confo Therapeutics to develop central nervous system disease treatments.
For further details see:
Daiichi Sankyo leukemia candidate review extended three months by FDA