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European Biopharmaceutical Review

Risk Ratio

On 30 August 2017, the US FDA formally approved the application for Kymriah, a cancer immunotherapy utilising modified human T-cells that express chimeric antigen receptors (CAR-T). This momentous event follows a decade of intense work to commercialise a therapy that was first demonstrated in 2011 in a handful of terminal paediatric leukaemia patients. At this moment, many CAR variants are in development, alongside a biotechnology business frenzy.

Pre-genomic immunotherapy consisted of human immunoglobulin injections to boost immunity during disease outbreaks. Clearly, this was a blunt instrument. Half a century later, a group at the University of Pennsylvania described remission in paediatric patients with refractory chronic lymphocytic leukaemia using genetically modified immune cells. Furthermore, at the beginning of September 2017, the first ever approval of CAR-T therapy was granted by the FDA for cases of acute lymphoblastic leukaemia in children and young adults. This inverts the usual regulatory paradigm by approving paediatric indications first.

In their Harvard Business Review paper ‘How to Spot a Technological Winner’, Graham and White discuss the factors that influence the success of a transformative innovation. The present intensity of the commercial race in cancer immunotherapy and gene-editing reflects a belief within the biopharmaceutical community that the trade-off of business drivers and technical hurdles is favourable. In just a few years, the number of groups working in this field has expanded from just a handful to over 200.

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Emile Bellott is a member of the EBR Industry Advisory Board and an industry consultant with experience in drug discovery, development and pharmaceutical outsourcing.
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Emile Bellott
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