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European Alliance for Personalised Medicine discusses historic FDA approval for CAR T-cell therapy

At a roundtable discussion during the ESMO 2017 Congress in Madrid, European Alliance for Personalised Medicine stakeholders will discuss the recent US Food and Drug Administration (FDA) decision to approve the first treatment aimed at redesigning a patient's own immune system to push it into attacking cancer.

The meeting at the ESMO Congress in the Spanish capital will be the fifth such roundtable conducted by the Alliance, with this interaction being one key aspect of EAPM’s stated goals - to engage with the medical community whenever possible, and at every level.

The FDA approval of CAR-T cell therapy has been described by regulatory members as a “historic” approval, and the EAPM agrees, hailing it as a “new frontier”.

The therapy has been developed to tackle acute lymphoblastic leukaemia when more traditional treatment fails, and has left 83% of such patients free of the blood cancer.

At the moment the price of this "living drug" therapy is out of reach for many healthcare systems but still represents a huge and exciting leap forward, being tailor-made to individual patients.

This is not the case with therapies such as surgery or chemotherapy.

CAR-T cells are made by extracting white blood cells from the patient's blood for genetic reprogramming, adding specific tumour antigen binding sites to deliver cancer therapy with pinpoint accuracy.

These cells are replanted inside the patient’s body, and the reintroduced cells multiply and go to work.

FDA spokesman, Dr Scott Gottlieb, has been quoted as saying "We're entering a new frontier in medical innovation with the ability to re-programme a patient's own cells to attack a deadly cancer. New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses.”

The news is certain to be an important topic attendant to the fact that new discoveries - generated from a deeper understanding of the human genome - are driving a paradigm shift in medicine from a one-size-fits-all approach to one which is personalised and targeted to the individual.

This shift is rapidly progressing in oncology as the FDA decision illustrates.

However, there are many barriers to innovation in clinical practice - including market access, scientific, and/or regulatory challenges - the biggest challenge across the healthcare system is continuing medical education.

Education should be a top priority when it comes to modernising healthcare systems, yet most educational programmes are less than optimal (an area that EAPM has already begun to address through its Summer Schools held in 2016 and earlier this year).

The forthcoming programme of EAPM Congress in Belfast aims to bring together stakeholders from the worlds of genetics, imaging, cutting-edge IVDs, pricing, incentives, reimbursement and more, to build a better healthcare future for all Europeans through, among other things, shared decision making and cooperation.

A key aim is to also allow for cross-fertilisation between the different disease and policy areas, allow delegates to gain a greater depth of knowledge into barriers in the field of personalised medicine, and offer up valuable evidence and stakeholder opinion on which policy makers can base their decision making on how better to integrate personalised medicine into the EU’s healthcare services.

For more on the upcoming event, click here.

Source: EAPM




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