For those of us watching the emerging treatment landscape, the past two years have seen a particular and exciting boom in the approval of innovative cell and gene therapies.
Across multiple conditions, 2022 saw the US and EU grant 11 new regulatory approvals, with 2023 following closely behind with 7 Food and Drug Administration (FDA) approvals in the space.
Promising recent news has also seen the FDA lift a 2-month partial clinical hold on Iovance Biotherapeutics’ Phase II trial of LN-145 – a tumour-infiltrating lymphocyte therapy designed to target non-small cell lung cancer.
Core to this progression was joint working between the organisation and both the FDA and an independent data monitoring committee as a core component in ensuring additional trial monitoring and safety measures were in place, highlighting the critical value of collaborative approaches when advancing the development pipeline.
