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Table 2 Currently approved Gene Therapy Products for Cancer treatment

From: Oncolytic virus-based suicide gene therapy for cancer treatment: a perspective of the clinical trials conducted at Henry Ford Health

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)