Gene Therapy in Cancer and consideration for the initiation of these therapies in Clinical Practice.

Abstract

Cancer is a complex and multifactorial disease which can be associated with both genetic and environmental abnormalities. Gene therapy medicines are classified as advanced therapy medicinal products (ATMPs). The use of ATMPs in cancer is a new era in medicine, which requires the support from specialist and experienced staff and the regulatory authorities to introduce gene therapy medicines safely and effectively into clinical practice. In Europe, the European Medicines Agency (EMA) has approved a Gene therapy Medicinal Product (GTMP), Talimogene Laherperepvec (Imlygic) for melanoma, a Cell Therapy Medicines Product (CTMP), Zalmoxis for patients with haematopoietic Stem Cell Transplantation (SCT) and two Chimeric antigen receptor T-cell therapies (CAR-T cells), Tisagenlecleucel (Kymriah) and Axicabtagene ciloleucel (Yescarta), for the treatment of acute lymphoblastic leukaemia (ALL) and diffuse large B-cell lymphoma (DLBCL). Regulatory authorities, expert members in this field, and experience from clinical trials have come together to build guidance and provide advice on how to initiate these novel therapies in clinical practice. Risk assessments and standard operating procedures should be in place before gene therapy is introduced in healthcare centres. Gene therapy in cancer is an exciting new era, with challenges for healthcare professionals to implement, manage and monitor this new group of therapy. Clinical exposure and extensive research have provided a deeper understanding and improvement of medicines optimisation and safety. Scientific and safety challenges are being explored and answered in clinical trial settings, with safety precautions always being paramount to ensure the efficiency and the safe delivery of these therapies. In this review, we will summarize the gene therapy medicinal products that are licensed in the UK and the challenges that need to be taken into consideration before hospital pharmacy initiates those therapies in clinical practice.