Table 1 Gene therapy products approved by the FDA
Company | Product | Brand name | Indication | Approval date |
|---|---|---|---|---|
Amgen | Talimogene laherparepvec (genetically modified, attenuated herpes simplex virus type 1) | Imlygic | Local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after surgery | 27 October 2015 |
Novartis | Tisagenlecleucel | Kymriah | Patients up to 25 years of age with relapsed or refractory B-cell acute lymphoblastic lymphoma; adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy | 30 August 2017 and 1 May 2018 |
Gilead and Kite Pharma | Axicabtagene ciloleucel | Yescarta | Adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy | 18 October 2017 |
Spark Therapeutics | Voretigene neparvovec-rzyl | Luxturna | Confirmed biallelic RPE65-mutation-associated retinal dystrophy | 19 December 2017 |
