Table 2.
Currently approved Gene Therapy Products for Cancer treatment
| Tradename | Proper Name | Approved on | Approval agency | Marketing-authorisation holder | Indication/ Therapeutic area |
|---|---|---|---|---|---|
| REXIN-G | Retroviral Expression Vectors Bearing Inhibitory Genes | September 2003 | U.S. Food & Drug Administration (US-FDA) | Epeius Biotechnologies | Metastatic cancers |
| GENDICINE | Recombinant human p53 oncolytic adenovirus | October 2003 | China State Food & Drug Administration (CFDA) | Shenzhen SiBiono GeneTech | Head and neck cancer |
| ONCORINE | Recombinant Human Adenovirus Type 5 Injection | November 2005 | China State Food & Drug Administration (CFDA) | Shanghai Sunway Biotech | Head and neck and esophagus cancer, Nasopharyngeal cancer, etc |
| PROVENGE | Sipuleucel-T | April 2010 | U.S. Food & Drug Administration (US-FDA) | Dendreon Corporation | Treatment of metastatic castrate resistant (hormone refractory) prostate cancer |
| IMLYGIC | Talimogene laherparepvec |
December 2015 December 2021 |
European Medicines Agency (EMA) U.S. Food & Drug Administration (US-FDA) |
Amgen Europe B.V | Melanoma |
| KYMRIAH | Tisagenlecleucel |
August 2017 August 2018 |
U.S. Food & Drug Administration (US-FDA) European Medicines Agency (EMA) |
Novartis Pharmaceuticals Corporation | Relapsed B-cell acute lymphoblastic leukemia |
| YESCARTA | Axicabtagene ciloleucel |
October 2017 August 2018 |
U.S. Food & Drug Administration (US-FDA) European Medicines Agency (EMA) |
Kite Pharma EU B.V., NL | Relapsed or refractory large B-cell lymphoma |
| TECARTUS | Brexucabtagene autoleucel |
July 2020 December 2020 |
U.S. Food & Drug Administration (US-FDA) European Medicines Agency (EMA) |
Kite Pharma EU B.V., NL | Relapsed or refractory mantle cell lymphoma (MCL) or B-cell precursor acute lymphoblastic leukemia (ALL) |
| BREYANZI | Lisocabtagene maraleucel | February 2021 | U.S. Food & Drug Administration (US-FDA) | Juno Therapeutics, Inc | Relapsed or refractory large B-cell lymphoma |
| ABECMA | Idecabtagene vicleucel | March 2021 | U.S. Food & Drug Administration (US-FDA) and European Medicines Agency (EMA) | Celgene Corporation | Relapsed or refractory multiple myeloma |
| CARVYKTI | Ciltacabtagene autoleucel | February 2022 | U.S. Food & Drug Administration (US-FDA) | Janssen Biotech, Inc | Relapsed or refractory multiple myeloma |
| ADSTILADRIN | nadofaragene firadenovec-vncg | December 2022 | U.S. Food & Drug Administration (US-FDA) | Ferring Pharmaceuticals A/S | High-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) |