Cynata Therapeutics (ASX:CYP) says FDA approval for Novartis' KYMRIAH (tisagenlecleucel), a chimeric antigen receptor T cell (CAR-T) treatment for relapsed acute lymphoblastic leukaemia in paediatric and adolescent patients, is a positive sign for its own commercialisation plans.
CAR-T treatments are gene therapies manufactured for each individual patient using their own immune cells. The cost of treatment is around half a million dollars.
FDA approval for KYMRIAH follows the announcement of Gilead's US$11.9 billion acquisition of Kite Pharma.
Earlier this week, Gilead announced plans to acquire Kite Pharma in a US$11.9b transaction. Kite is focussed on developing similar CAR-T cell products for cancer. Kite is also developing a CAR-T therapy. It is currently under consideration by the FDA.
Cynata has previously announced its own patent applications around its Cymerus technology in immunotherapy treatments, including chimeric antigen receptor T cell (CAR-T) and checkpoint inhibitor-based therapies.
According to managing director and CEO Ross Macdonald, these recent developments "...have firmly established the use of cells as medicine and confirmed that cellular therapy is a key category and no longer an evolving market."