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Doxorubicin wrapped in a fatty bubble so it reaches tumours with less heart damage; a workhorse of relapsed ovarian cancer.
Approved 1995 (Kaposi sarcoma) and 1999 for platinum-refractory ovarian cancer. Standard single agent or partner (with carboplatin in CALYPSO, with trabectedin in OVA-301, with bevacizumab in AURELIA) in relapsed disease; the comparator arm in MIRASOL and KEYNOTE-B96. Hand-foot syndrome and mucositis replace the alopecia and cardiotoxicity of free doxorubicin.
It was invented in Jerusalem. Yechezkel Barenholz's Laboratory of Membrane and Liposome Research at the Hebrew University, with the clinician Alberto Gabizon, combined three unrelated ideas: a polyethylene-glycol coat that keeps the liposome circulating and away from the reticuloendothelial system, remote loading of doxorubicin down a transmembrane ammonium sulfate gradient that holds the drug in and releases it at the tumour, and a bilayer kept in a liquid-ordered phase by a high-melting phosphatidylcholine with cholesterol. Licensed through the university's Yissum company, it became in 1995 the first nano-drug approved by any regulator; Barenholz's own retrospective sets out what the first twenty years taught.
Topoisomerase II poisoning and DNA intercalation by doxorubicin, delivered by long-circulating PEGylated liposomes that extravasate in tumours.
1.Pegylated liposomal doxorubicin slips into a pocket on its target.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Generic liposomal doxorubicin is available; Doxil coverage is the same benefit.
Multi-source generic; covered under the medical benefit without prior authorisation in most plans, as part of standard regimens.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA91 · SMC advice: pegylated liposomal doxorubicin. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Kaposi's sarcoma in AIDS patients with disease progression on prior combination chemotherapy or who are intolerant to such therapy
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Metastatic ovarian carcinoma refractory to paclitaxel and platinum-based chemotherapy
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Metastatic ovarian carcinoma refractory to paclitaxel and platinum-based chemotherapy
Confirmed: the accelerated approval of 1999 converted to traditional approval 5.6 years after it was granted.
Kaposi's sarcoma in AIDS patients with disease progression on prior combination chemotherapy or who are intolerant to such therapy
Confirmed: the accelerated approval of 1995 converted to traditional approval 12.6 years after it was granted.
| Region | Year | Indication |
|---|---|---|
| US | 1995 | AIDS-related Kaposi sarcoma after prior chemotherapy (Doxil, NDA 050718) |
| US | 1999 | Ovarian cancer refractory to platinum and paclitaxel |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Palmar-plantar erythrodysaesthesia | 51% | 24% |
| Stomatitis | 41% | 8% |
Doxil label, ovarian. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
Read for the class this product belongs to (anthracyclines) unless the answer names the product. Population figures from the cohorts named, not a prediction for one person. Blank where no source gives a recovery figure.
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Query for this drug: (TITLE:"Pegylated liposomal doxorubicin" OR ABSTRACT:"Pegylated liposomal doxorubicin" OR TITLE:"Doxil" OR ABSTRACT:"Doxil" OR TITLE:"Caelyx" OR ABSTRACT:"Caelyx") 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 Pegylated liposomal doxorubicin, not a curated reading list.
Shares A Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer (BEHOLD-Ovarian01), AURELIA, REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1, An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Can.
Shares An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Can, Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer, Platinum-resistant ovarian cancer, Topoisomerase-I inhibitors (and ADC payloads).
Shares Yechezkel Barenholz, Hebrew University of Jerusalem, Multiple myeloma, Diffuse large B-cell lymphoma.
Shares AURELIA, Platinum-resistant ovarian cancer, Ovarian cancer.
Shares Alberto Gabizon, Hebrew University of Jerusalem, Ovarian cancer.
Shares REFRaME-O1: A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigator's Choice (IC) Chemotherapy in Women With Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing FOLR1, Platinum-resistant ovarian cancer, Ovarian cancer.
Shares Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer, Platinum-sensitive ovarian cancer, Ovarian cancer.
Shares Hebrew University of Jerusalem, Multiple myeloma, Diffuse large B-cell lymphoma.