FDA Grants Priority Review to Duvelisib for CLL/SLL and Follicular Lymphoma
The FDA is reviewing a New Drug Application, which is requesting full approval for CLL/SLL and accelerated approval for follicular lymphoma.
The FDA is reviewing a New Drug Application, which is requesting full approval for CLL/SLL and accelerated approval for follicular lymphoma.
The median PFS was significantly longer in the R-B arm: 15.0 years compared with 11.7 years in the R-CHOP arm.
The open-label, multicenter, phase 3 FOLL05 trial included untreated patients with grade 1, 2, or 3a and Ann Arbor stage II to IV disease. This analysis included 504 evaluable patients.
The FDA granted accelerated approval to copanlisib for the treatment of adult patients with relapsed follicular lymphoma who have received at least 2 prior treatments.
Patients with untreated FL were randomly assigned to receive cyclophosphamide, vincristine, and prednisone (CVP) plus rituximab (R) or GP2013 for 8 cycles followed by 2 years of monotherapy maintenance in patients who responded to treatment.
Researchers enrolled patients with FL to investigate the cumulative incidence of HT, risk factors associated with HT, and the role of treatment and response on survival following transformation.
[Cancer Management and Research] This research summarizes the role of rituximab across the spectrum of FL treatment and the evolving therapeutic landscape with the emergence of novel agents currently in clinical development.
Subcutaneous rituximab has similar efficacy and safety as the intravenous formulation for the first-line treatment of follicular lymphoma.