FDA Warns About Risk-Benefit Balance of Duvelisib for CLL

The PI3K inhibitor duvelisib (Copiktra, Secura Bio) initially showed modest effectiveness in the DUO trial, leading to its FDA approval in 2018 for patients with relapsed or refractory CLL/SLL. This approval was based on comparisons with ofatumumab, a drug no longer used in CLL treatment. 

However, long-term results from the study revealed significant toxicity concerns. Duvelisib was found to increase the risk of death by 15% and was associated with severe side effects, including serious infections, diarrhea/colitis, skin reactions, and pneumonitis. 

Due to these safety risks, the FDA’s Oncologic Drug Advisory Committee voted 8 to 4 against duvelisib’s use in CLL. One committee member even described its use as “playing with fire.”

Despite these concerns, the FDA has not revoked its approval, as the risks are clearly outlined in its safety warnings. 

This article is simply meant to inform patients who may be offered duvelisib as a treatment option, whether by their healthcare provider or in a clinical trial, to carefully consider its risks. 

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Sources:

• FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)
• ODAC Votes Against Duvelisib for Relapsed or Refractory CLL/SLL