FDA Grants Priority Review to Drug for Relapsed/Refractory Follicular Lymphoma

The U.S. Food and Drug Administration (FDA) has granted priority review to copanlisib for the treatment of patients with relapsed/refractory follicular lymphoma who have received at least two prior therapies.

Copanlisib was submitted for priority-review consideration based on results of the open-label, single-arm, phase II CHRONOS-1 study.

The study evaluated copanlisib as a monotherapy for 104 patients with indolent follicular lymphoma who had relapsed or were refractory to two or more prior therapies. Patients received copanlisib 60 mg intravenously on days 1, 8, and 15 of a 28-day cycle.

Sixty-two percent (n=65) of patients were refractory to treatment and the median number of prior lines of therapy was three (range = 2-8).

The overall response rate was 58.7 percent: 14.4 percent (n=15) of patients achieved complete response and 44.4 percent (n=46) achieved partial response. Stable disease was achieved in 33.7 percent of patients (n=35).

The most common all-grade adverse events (observed in >25% of patients) were:

  • diarrhea (34%)
  • reduced neutrophil count (30%)
  • fatigue (30%)
  • fever (25%)

The most common grade ≥3 adverse events observed in patients were:

  • diarrhea (5%)
  • reduced neutrophil count (24%)
  • fatigue (2%)
  • fever (4%)

Six patients died during study follow-up; three of the deaths were considered treatment-related (one lung infection, one respiratory failure, and one thrombosis).

Copanlisib was previously granted fast-track and orphan-drug designations by the FDA.

Sources: Bayer press release, May 17, 2017; Dreyling M, Santoro A, Leppa S, et al. Copanlisib in patients with relapsed or refractory follicular lymphoma. Abstract #7535. Presented at the 2017 ASCO Annual Meeting, June 5, 2017; Chicago, Illinois.