The FDA announced Breakthrough Therapy Designation (BTD) for acalabrutinib (Calquence) as a single agent to treat chronic lymphocytic leukemia (CLL)
Maybe some good news soon. Having another meaningful option to treat our CLL is always good news.
April 9, 2018 – The U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its New Drug Application (NDA) for duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, for which Verastem is seeking full approval for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL). The application was submitted February 7, 2018.
Priority Review is granted by the FDA to drugs that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition. Duvelisib has received Fast Track Designation from the FDA for patients with CLL who have received at least one prior therapy and for patients with FL who have received at least two prior therapies. In addition, duvelisib received orphan drug designation in the United States and the European Union for patients with CLL, SLL and FL.
The FDA target action date is October 5, 2018.
Read more:
https://cllsociety.org/2018/02/verastem-nda-fda-duvelisib-rrcll/
Related posts
