Chimeric antigen receptor T cell (CAR-T) therapy has indisputably become one of the industry’s hottest topics and the next 18 months could see the first CAR-T drugs filed for US approval. But behind the excitement for all things CAR-T lie a number of obstacles in their path to approval.
In its second deep-dive into the CAR-T space EP Vantage explores how much of an advantage it will be for the first company to achieve approval in a market that has never been tested and the ability to charge premium pricing can only be guessed at.
The complexity and expense of manufacturing
The poor durability of many current CAR constructs
The growing ways by which tumour cells can become resistant to CAR-T therapy
The fear of severe toxicities
The cost and reimbursement questions surrounding CAR-T treatments