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Cancer Nano-Therapies in the Clinic and Clinical Trials

The true measure of nanotechnology success in medicine and oncology lies in effectively translating research discoveries into the clinic for improved disease diagnosis and treatment. Although the use of nanotechnology for cancer diagnosis and treatment is largely still in the development phase, several nanocarrier-based drugs are already available, and many more nano-based therapeutics are undergoing clinical trials. Nanotechnology in oncology includes the use of precisely engineered materials to develop novel therapies and devices that may reduce toxicity as well as enhance the efficacy and delivery of treatments. Notably, Doxil® and Abraxane®, the most well known nano-based drugs, were approved by FDA several years ago and have been used successfully in clinical practice. A complete list of cancer nano-therapeutics approved by FDA and regulatory agencies of other countries is given below. Access a comprehensive list of the current U.S. clinical trials involving cancer nanotechnology.

Approved Cancer Drug Therapies Based on Nanotechnology (EMA: European Medicines Agency; FDA: US Food and Drug Administration; Adapted from Andreas Wicki, et al., J Control Release, 2015 and Francisco Rodriguez, et al., Biomolecules, 2022)

Approval (year) Product Company Nanoparticle material Drug/Mechanism Indication
EMA (2019) Hensify (NBTXR3) Nanobiotix Hafnium oxide nanoparticle Radiotherapy Locally advanced soft tissue sarcoma (STS)
EMA (2019) Pazenir Ratiopharm GmbH Nanoparticle-bound albumin Paclitaxel Metastatic breast cancer, metastatic adenocarcinoma of the pancreas, non-small cell lung cancer
FDA (2017) EMA (2018) Vyxeos Celator/Jazz Pharma Liposome   Cytarabine/Daunorubicin Acute myeloid leukemia
FDA (2015) Onivyde Merrimack Pharma Liposome Irinotecan Pancreatic cancer, colorectal cancer
EMA (2010, 2013) NanoTherm MagForce Nanotechnologies AG Iron oxide nanoparticles Thermal ablation with magnetic field Glioblastoma, prostate, and pancreatic cancer
FDA (2012) Marqibo Talon Therapeutics/ Spectrum Pharmaceuticals Liposome Vincristine Acute lymphoblastic leukemia
EMA (2009) Mepact Takeda Pharmaceuticals Liposome Mifamurtide MTP-PE Osteosarcoma
South Korea (2007) Genexol-PM Samyang Biopharmaceuticals PEG-PLA polymeric micelle Paclitaxel Breast, lung, ovarian cancer
FDA (1994, 2006) Oncaspar Enzon-Sigma-tau Polymer protein conjugate Pegaspargase/L-asparaginase Acute lymphoblastic leukemia
FDA (2005) Abraxane Abraxis/Celgene Nanoparticle-bound albumin Paclitaxel Breast and pancreatic cancer, non-small-cell lung cancer
FDA (1999) DepoCyt Pacira Pharmaceuticals  Liposome Cytarabine Neoplastic meningitis
FDA (1996) DaunoXome Gilead Sciences Liposome Daunorubicin Kaposi’s sarcoma
FDA (1995, 1999, 2007), EMA (1996, 2000), Taiwan (1998) Doxil, Caelyx, Myocet, and Lipo-Dox Johnson and Johnson, Schering-Plough, Teva UK, and TTY Biopharm Liposome Doxorubicin Metastatic breast cancer, ovarian cancer, Kaposi’s sarcoma, multiple myeloma

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