Thirty years from FDA approval of pegylated liposomal doxorubicin (Doxil/Caelyx): an updated analysis and future perspective
In 2025, it will be 30 years since the initial clinical approval of pegylated liposomal doxorubicin (PLD) by the Food and Drug Administration. PLD predated the field of nanomedicine and became a model nanomedicine setting key pharmacological principles (prolonged circulation, slow drug release and t...
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BMJ Publishing Group
2025-01-01
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| Series: | BMJ Oncology |
| Online Access: | https://bmjoncology.bmj.com/content/4/1/e000573.full |
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| author | Alberto A Gabizon Shira Gabizon-Peretz Shadan Modaresahmadi Ninh M La-Beck |
| author_facet | Alberto A Gabizon Shira Gabizon-Peretz Shadan Modaresahmadi Ninh M La-Beck |
| author_sort | Alberto A Gabizon |
| collection | DOAJ |
| description | In 2025, it will be 30 years since the initial clinical approval of pegylated liposomal doxorubicin (PLD) by the Food and Drug Administration. PLD predated the field of nanomedicine and became a model nanomedicine setting key pharmacological principles (prolonged circulation, slow drug release and the enhanced permeability and retention (EPR) effect) for clinical application of other nano-drugs in cancer therapy. The impressive reduction of cardiotoxicity conferred by PLD is the most valuable clinical asset. While PLD has gained a strong foothold in relapsed ovarian cancer and metastatic breast cancer, it has not been extensively tested in primary (neoadjuvant) and adjuvant therapy and has not fulfilled the expectations from the results in animal models efficacy-wise. This discrepancy may be due to the large dose gap between mice and humans and the apparent variability of the EPR effect in human cancer. PLD is a complex product and we are still in a learning curve regarding a number of factors such as its interaction with the complement system and its immune modulatory properties, as well as its integration in multimodality therapy that may potentiate its value and role in cancer therapy. |
| format | Article |
| id | doaj-art-5bd9e23cad2749f995ec5a259dcec3dd |
| institution | Kabale University |
| issn | 2752-7948 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Oncology |
| spelling | doaj-art-5bd9e23cad2749f995ec5a259dcec3dd2025-01-10T02:05:10ZengBMJ Publishing GroupBMJ Oncology2752-79482025-01-014110.1136/bmjonc-2024-000573Thirty years from FDA approval of pegylated liposomal doxorubicin (Doxil/Caelyx): an updated analysis and future perspectiveAlberto A Gabizon0Shira Gabizon-Peretz1Shadan Modaresahmadi2Ninh M La-Beck3The Leah and Jakub Susskind Nano-Oncology Research Laboratory, Helmsley Cancer Center, Shaare Zedek Medical Center, Jerusalem, IsraelDavidoff Cancer Center, Rabin Medical Center, Petah Tikva, Central, IsraelDepartment of Immunotherapeutics and Biotechnology, Texas Tech University Health Sciences Center, Jerry H Hodge School of Pharmacy, Abilene, Texas, USADepartment of Immunotherapeutics and Biotechnology, Texas Tech University Health Sciences Center, Jerry H Hodge School of Pharmacy, Abilene, Texas, USAIn 2025, it will be 30 years since the initial clinical approval of pegylated liposomal doxorubicin (PLD) by the Food and Drug Administration. PLD predated the field of nanomedicine and became a model nanomedicine setting key pharmacological principles (prolonged circulation, slow drug release and the enhanced permeability and retention (EPR) effect) for clinical application of other nano-drugs in cancer therapy. The impressive reduction of cardiotoxicity conferred by PLD is the most valuable clinical asset. While PLD has gained a strong foothold in relapsed ovarian cancer and metastatic breast cancer, it has not been extensively tested in primary (neoadjuvant) and adjuvant therapy and has not fulfilled the expectations from the results in animal models efficacy-wise. This discrepancy may be due to the large dose gap between mice and humans and the apparent variability of the EPR effect in human cancer. PLD is a complex product and we are still in a learning curve regarding a number of factors such as its interaction with the complement system and its immune modulatory properties, as well as its integration in multimodality therapy that may potentiate its value and role in cancer therapy.https://bmjoncology.bmj.com/content/4/1/e000573.full |
| spellingShingle | Alberto A Gabizon Shira Gabizon-Peretz Shadan Modaresahmadi Ninh M La-Beck Thirty years from FDA approval of pegylated liposomal doxorubicin (Doxil/Caelyx): an updated analysis and future perspective BMJ Oncology |
| title | Thirty years from FDA approval of pegylated liposomal doxorubicin (Doxil/Caelyx): an updated analysis and future perspective |
| title_full | Thirty years from FDA approval of pegylated liposomal doxorubicin (Doxil/Caelyx): an updated analysis and future perspective |
| title_fullStr | Thirty years from FDA approval of pegylated liposomal doxorubicin (Doxil/Caelyx): an updated analysis and future perspective |
| title_full_unstemmed | Thirty years from FDA approval of pegylated liposomal doxorubicin (Doxil/Caelyx): an updated analysis and future perspective |
| title_short | Thirty years from FDA approval of pegylated liposomal doxorubicin (Doxil/Caelyx): an updated analysis and future perspective |
| title_sort | thirty years from fda approval of pegylated liposomal doxorubicin doxil caelyx an updated analysis and future perspective |
| url | https://bmjoncology.bmj.com/content/4/1/e000573.full |
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