A new drug application (NDA) has been submitted to the FDA for duvelisib for a full approval for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and an accelerated approval for the treatment of patients with relapsed/refractory follicular lymphoma.
The most common grade ≥3 AEs were neutropenia (23%), anemia (12%), thrombocytopenia (10%), and diarrhea (15%). Seventeen percent of patients discontinued duvelisib due to an AE. There were 6 patient deaths related to AEs.
Verastem submits new drug application to US FDA for duvelisib for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and follicular lymphoma. Verastem. Published February 7, 2018, Accessed February 7, 2018. http://bit.ly/2GT3m2u.
... to read the full story