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PI3K inhibitors
Source: Chronic Lymphocytic Leukemia Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: April 25, 2025 · Captured 2026-09-09.
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Idelalisib is an oral inhibitor of the delta isoform of PI3K, which is in the B-cell receptor-signaling cascade. This drug has been withdrawn from its U.S. Food and Drug Administration (FDA) indication due to toxicity and is no longer available. Duvelisib is an oral dual inhibitor of the delta and gamma isoforms of PI3K.[13]
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In a prospective trial, 319 patients with relapsed and refractory CLL/small lymphocytic lymphoma were randomly assigned to receive duvelisib versus ofatumumab.[14]
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In a prospective trial, 319 patients with relapsed and refractory CLL/small lymphocytic lymphoma were randomly assigned to receive duvelisib versus ofatumumab.[14]
With a median follow-up of 22.4 months, the median PFS was significantly higher for patients who received duvelisib, at 13.3 months, than for patients who received ofatumumab, at 9.9 months (hazard ratio [HR], 0.52; P < .0001).[14][Level of evidence B1]
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In a prospective trial, 319 patients with relapsed and refractory CLL/small lymphocytic lymphoma were randomly assigned to receive duvelisib versus ofatumumab.[14]
Serious side effects include infections, pneumonitis, diarrhea or colitis, dermatitis, neutropenia, rash, fatigue, pyrexia, nausea, anemia, and transaminitis.
In a prospective trial, 319 patients with relapsed and refractory CLL/small lymphocytic lymphoma were randomly assigned to receive duvelisib versus ofatumumab.[14]
The FDA has approved duvelisib for third-line (or greater) use. However, follow-up data submitted to the FDA showed, with a median follow-up of 63 months, a median OS of 52.3 months (95% CI, 41.8–68.0) in the duvelisib group and 63.3 months (95% CI, 41.2–not estimable) in the ofatumumab group.[15]
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Preserved source evidence · Not medical advice