Novartis’ Kymriah & Gilead’s Yescarta become first EU-approved CAR T therapies

pharmafile | August 28, 2018 | News story | Manufacturing and Production, Sales and Marketing CAR T, CAR-T, Cancer, EU, Gilead, Kymriah, Novartis, UK, Yescarta, blood cancer, pharma 

Almost one full year since the treatment was given a “historic” approval in the US, Novartis’ CAR T therapy Kymriah (tisagenlecleucel) has been awarded marketing authorisation in the EU for the treatment of blood cancer. Its rival, Gilead/Kite Therapeutics’ Yescarta (axicabtagene ciloleucel) has also been authorised, marking the first approval of its kind in the region.

As CAR-T therapies, both are manufactured from immune cells derived from a specific patient’s body. Kymriah has secured approval in patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse, as well as in the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Yescarta has been approved as a treatment for adult patients with relapsed or refractory DLBCL and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.

Given the nature of the treatment, the decisions were based on previous assessments from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) earlier this year.

“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,” commented Professor Peter Bader, Head of the Division for Stem Cell Transplantation and Immunology and Principal Investigator of the ELIANA study at the University Hospital for Children and Adolescents in Frankfurt/Main,” while Liz Barrett, CEO, Novartis Oncology, added: “The Kymriah approval is a transformational milestone for patients in Europe in need of new treatment options. 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.”

Kymriah made headlines for its $475,000 price tag for a one-time treatment, but Novartis gave no indication of what the therapy would cost for patients in Europe. Both treatments were deemed safe, but the primary concern over the risk of potentially lethal cytokine release syndrome (CRS) remains.

Dr Alessandro Riva, Executive Vice President, Oncology Therapeutics & Head, Cell Therapy at Gilead, also remarked: “We are proud to be leading this frontier of cancer innovation that is bringing novel, personalised therapy to people living with these blood cancers. Our vision is for cell therapy to serve as the foundation for treating all cancer types. Today’s milestone is another step on this exciting and important journey.”

Despite the ground-breaking news that both treatments would become available in Europe, UK watchdog NICE has confirmed it will not be recommending either product for use on the NHS as their benefit/cost-effectiveness could not be adequately determined.

Matt Fellows

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