{"entity":{"id":"duvelisib","kind":"drug","name":"Duvelisib","aka":[],"tldr":"A dual PI3K inhibitor for relapsed CLL whose survival data raised FDA concern; use is now limited to late lines.","summary":"DUO (2018): PFS 13.3 vs 9.9 months versus ofatumumab in relapsed CLL. Approved 2018 (CLL/SLL after 2 lines; FL accelerated, withdrawn 2021). A 2022 FDA review found a possible increase in deaths; boxed warnings for infections, diarrhoea/colitis, cutaneous reactions and pneumonitis. Studied in PTCL (PRIMO).","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Duvelisib","links":[{"label":"Label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=duvelisib"}],"tags":["gap-fill"],"related":[],"cancers":["cll","peripheral-t-cell-lymphoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["pik3ca"],"drugs":[],"companies":["infinity-pharmaceuticals"],"institutions":[],"pathways":["pi3k-akt-mtor"],"terms":[],"trials":["nct06522737"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Copiktra","modality":"Small-molecule PI3Kδ/γ inhibitor","mechanism":"Dual inhibition of PI3K delta (malignant B cells) and gamma (T cells, macrophages in the microenvironment).","approvals":[{"region":"US","year":2018,"indication":"Relapsed/refractory CLL/SLL after ≥2 prior therapies; FL (withdrawn 2021)"},{"region":"EU","year":2021,"indication":"CLL after ≥2 therapies; FL after ≥2 therapies"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2018-09-24","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapies"},{"date":"2021-12-17","type":"withdrawal","region":"US","note":"Withdrawn: the indication came off the label 3.2 years after its accelerated approval.","indication":"Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapies"}]},"route":"/drugs/duvelisib/","neighbours":{"cancer":[{"id":"cll","kind":"cancer","name":"Chronic lymphocytic leukaemia","route":"/cancers/cll/"},{"id":"peripheral-t-cell-lymphoma","kind":"cancer","name":"Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)","route":"/cancers/peripheral-t-cell-lymphoma/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"pik3cd","kind":"target","name":"PI3K delta (PIK3CD)","route":"/targets/pik3cd/"},{"id":"pik3ca","kind":"target","name":"PIK3CA / PI3K-alpha","route":"/targets/pik3ca/"}],"company":[{"id":"infinity-pharmaceuticals","kind":"company","name":"Infinity Pharmaceuticals","route":"/companies/infinity-pharmaceuticals/"},{"id":"securabio","kind":"company","name":"SecuraBio","route":"/companies/securabio/"}],"pathway":[{"id":"pi3k-akt-mtor","kind":"pathway","name":"PI3K / AKT / mTOR","route":"/pathways/pi3k-akt-mtor/"}],"trial":[{"id":"nct06522737","kind":"trial","name":"A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype","route":"/trials/nct06522737/"}],"term":[{"id":"approval-withdrawal","kind":"term","name":"Indication withdrawal","route":"/terms/approval-withdrawal/"},{"id":"lymphoma-tx-pjp-and-infection-prophylaxis","kind":"term","name":"Infection prophylaxis in lymphoma: PJP, herpes, fungal risk and vaccination","route":"/terms/lymphoma-tx-pjp-and-infection-prophylaxis/"}]}}