Japanese pharma Daiichi Sankyo will have to wait a little longer for the FDA’s review of its acute myeloid leukemia (AML) drug.
This week, the company announced that the agency has extended the review period for the New Drug Application of quizartinib, a tyrosine kinase inhibitor, for its use in combination with other standard chemotherapies for the treatment of FLT3-ITD positive AML by three months.
Quizartinib’s new Prescription Drug User Fee Act (PDUFA) is now July 24, 2023, which will allow the agency more time to review the proposed Risk Evaluation and Mitigation Strategies (REMS) included in the application. The drug’s NDA is supported by data from the QuANTUM-First clinical trial, which showed that patients treated with the drug had noteworthy improvement in overall survival when compared to those who only received chemotherapy.
In a recent statement, the company’s global head of oncology clinical development Mark Rutstein, said “We are continuing to work with the FDA to facilitate completion of their review of the quizartinib,” adding that the drug “has the potential to change the standard of care for patients with newly diagnosed FLT3-ITD positive AML.”
Despite being close to the finish line, the drug has had a bumpy road to approval. In 2019, the FDA turned down the treatment citing concern over the modest survival results, lack of robust data, the high proportion of randomized but untreated patients, and the risk for QT prolongation with the treatment.
