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Copanlisib is an intravenous PI3K inhibitor for relapsed follicular lymphoma, approved in 2017 and withdrawn in 2023 when its confirmatory trial failed.
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 Copanlisib is a case study in how a drug with a real response rate can still be withdrawn when confirmatory trials do not show a clear benefit that outweighs the class toxicity.
Weekly IV PI3K inhibition with PI3Kα and δ potency, reducing AKT signalling in B-cell lymphoma; hyperglycaemia and hypertension are on-target α effects. Connects to PIK3CA / PI3K-alpha.
1.Copanlisib slips into a pocket on PIK3CA / PI3K-alpha.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
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Treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies
Withdrawn: the indication came off the label 6.5 years after its accelerated approval.
| Region | Year | Indication |
|---|---|---|
| US | 2017 | Relapsed follicular lymphoma after ≥2 therapies · Withdrawn 2023 |
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Query for this drug: (TITLE:"Copanlisib" OR ABSTRACT:"Copanlisib" OR TITLE:"Aliqopa" OR ABSTRACT:"Aliqopa") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Copanlisib, not a curated reading list.
Shares PI3K delta (PIK3CD), Indication withdrawal, Infection prophylaxis in lymphoma: PJP, herpes, fungal risk and vaccination, PIK3CA / PI3K-alpha.
Shares PI3K delta (PIK3CD), Indication withdrawal, Infection prophylaxis in lymphoma: PJP, herpes, fungal risk and vaccination, PIK3CA / PI3K-alpha.
Shares Indication withdrawal, PIK3CA / PI3K-alpha, PI3K / AKT / mTOR, Follicular lymphoma.
Shares PI3K delta (PIK3CD), Follicular lymphoma.
Shares PI3K delta (PIK3CD), Follicular lymphoma.
Shares PI3K delta (PIK3CD), Follicular lymphoma.
Shares Bayer, Small-molecule kinase inhibitors.
Shares Bayer, Small-molecule kinase inhibitors.