{"entity":{"id":"copanlisib","kind":"drug","name":"Copanlisib","aka":[],"tldr":"Copanlisib is an intravenous PI3K inhibitor for relapsed follicular lymphoma, approved in 2017 and withdrawn in 2023 when its confirmatory trial failed.","summary":"Copanlisib is an intravenous pan-class I PI3K inhibitor with predominant PI3K-alpha and PI3K-delta activity, reducing AKT signalling in B-cell lymphoma. Weekly intravenous dosing gives intermittent exposure, and hyperglycaemia and hypertension are on-target alpha effects that appear during infusion. CHRONOS-1 showed a 59% response rate in relapsed indolent lymphoma, supporting accelerated US approval in 2017 for follicular lymphoma after at least two therapies. CHRONOS-3, which added copanlisib to rituximab, was positive for progression-free survival, but CHRONOS-4 failed. After the FDA class review of PI3K inhibitors in 2022, Bayer withdrew the US indication in November 2023. Copanlisib is a case study in how a drug with a real response rate can still be withdrawn when confirmatory trials do not show a clear benefit that outweighs the class toxicity.","status":"withdrawn","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Copanlisib","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Copanlisib"}],"tags":["gap-fill"],"related":[],"cancers":["follicular-lymphoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["pik3ca"],"drugs":[],"companies":["bayer"],"institutions":[],"pathways":["pi3k-akt-mtor"],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Aliqopa","modality":"Intravenous pan-class I PI3K inhibitor (α/δ predominant)","mechanism":"Weekly IV PI3K inhibition with PI3Kα and δ potency, reducing AKT signalling in B-cell lymphoma; hyperglycaemia and hypertension are on-target α effects.","approvals":[{"region":"US","year":2017,"indication":"Relapsed follicular lymphoma after ≥2 therapies","note":"Withdrawn 2023"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2017-09-14","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies"},{"date":"2024-03-18","type":"withdrawal","region":"US","note":"Withdrawn: the indication came off the label 6.5 years after its accelerated approval.","indication":"Treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies"}]},"route":"/drugs/copanlisib/","neighbours":{"cancer":[{"id":"follicular-lymphoma","kind":"cancer","name":"Follicular lymphoma","route":"/cancers/follicular-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":"bayer","kind":"company","name":"Bayer","route":"/companies/bayer/"}],"pathway":[{"id":"pi3k-akt-mtor","kind":"pathway","name":"PI3K / AKT / mTOR","route":"/pathways/pi3k-akt-mtor/"}],"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/"}],"trial":[{"id":"nci-match","kind":"trial","name":"NCI-MATCH (EAY131)","route":"/trials/nci-match/"}]}}