The US Food and Drug Administration (FDA) granted accelerated approval to copanlisib today for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least 2 prior treatments.1

Copanlisib, a pan-class 1 PI3K inhibitor, works by blocking cell growth–promoting enzymes.

The FDA based its decision from evidence from the single-arm, phase 2 CHRONOS-1 trial (ClinicalTrials.gov Identifier: NCT01660451), which evaluated the effects of copanlisib in 141 patients with varying subtypes of lymphoma. Copanlisib 60 mg was administered on days 1, 8, and 15 of a 28-day cycle.

The overall response rate was 59% in the 104 patients with FL, with a 14.4% complete response rate. The duration of response was 12.2 months (range, 0-22.6 months; 95% CI, 7.4-22.6) in refractory patients.2

The most common adverse events (AEs) observed with copanlisib include hyperglycemia, diarrhea, decreased general strength and energy, hypertension, leukopenia/neutropenia, nausea, lower respiratory tract infections, and thrombocytopenia.

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Accelerated approval is granted to therapies that target serious conditions and fill an unmet medical need. Approval is contingent on results from further clinical trials confirming clinical benefit.

Copanlisib has also been granted Priority Review designation and Orphan Drug Designation.

References

  1. FDA approves new treatment for adults with relapsed follicular lymphoma [news release]. Silver Spring, MD: US Food and Drug Administration; Updated September 14, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576129.htm. Accessed September 14, 2017.
  2. Dreyling M, Santoro A, Mollica L, et al. Copanlisib in patients with relapsed or refractory indolent B-cell lymphoma: primary results of the pivotal Chronos-1 study. Presented at the 2017 AACR Annual Meeting, April 4, 2017; Washington, DC. Abstract CT149.