Novartis: EU approve gene-modifying cancer therapy


This week Novartis received approval from the European Commission (EC) for Kymriah, their chimeric antigen receptor T cell (CAR-T) therapy for young people under 25 with cancer of the blood.

Leading the way in innovative cancer cures with an unrivalled portfolio of over 20 approved oncology medicines, Novartis is the only company in the world with an approved cell therapy for young patients with acute lymphoblastic leukaemia (ALL) that is refractory or in second or later relapse.

Continuing with their pioneering endeavours they are also the first big pharma firm to assemble a global business unit dedicated solely to developing and launching ground-breaking oncology medicines.

When speaking to Bruno Strigini, former CEO of Novartis Oncology in an interview last year he said, “One of the aspects that has impressed me the most since I joined Novartis, has been the sense of purpose of our associates and I believe that arises partly from having an organization fully focused on oncology. Looking at our productivity in 2017 alone, which includes three new therapy approvals, it is clear that the model we established makes good sense.”

The EU approval of the breakthrough gene-modifying therapy Kymriah comes just over a year after the drug was approved by the FDA in the US.

“The Kymriah approval is a transformational milestone for patients in Europe in need of new treatment options,” said Liz Barrett, CEO, Novartis Oncology. “Novartis will continue to build a global infrastructure for delivering CAR-T cell therapies where none existed before – remaining steadfast in our goal of reimagining cancer.”

The one-time therapy is a living medicinal product, manufactured individually for each patient by reprogramming his or her own immune system cells.

“Bringing Kymriah to patients in the EU advances the treatment paradigm in an unprecedented way and delivers a lifesaving therapy to young patients with ALL who have not been successfully treated with existing therapies, and who have limited options left,” said Prof. Peter Bader, Head of the Division for Stem Cell Transplantation and Immunology.

As the treatment is made available to more patients globally, Novartis has been actively pursuing options to expand manufacturing capabilities beyond their facility in Morris Plains, New Jersey, including an agreement with CELLforCURE in France.

Kymriah does not come cheap. The one-off treatment prices at US $475,000 making it one of the most expensive drugs of all time. Novartis is currently collaborating with national health and reimbursement authorities across Europe on a fair, value-based pricing approach that is sustainable for national healthcare systems.

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