Novartis to boost ability to manufacture new cancer drug in Europe

Switzerland’s Novartis is stepping up manufacturing capabilities in Europe for a pioneering cancer treatment, after winning European Commission approval for its use for children and young adults with a type of leukaemia.

The drug company said it would invest up to SFr90m (€78.8m) in production facilities in Switzerland for cell and gene therapies after winning EU approval for Kymriah, a treatment by which a patient’s own cells are used to fight cancer. The treatment is known as chimeric antigen receptor therapy, or Car-T.

Kymria was the first Car-T therapy approved by the US Food and Drug Administration. When launched in the US last year, Novartis said it would charge as much as $475,000 a patient for the new cancer therapy, putting it among the most expensive drugs of all time.

But on Monday, Novartis gave no indication of likely prices for the treatment in Europe, saying it continued to work with health authorities “on a fair, value-based pricing approach that is sustainable for national healthcare systems.” It also gave no details on when treatments would be launched — or in which EU countries.

The new treatment was authorised for use on patients up to 25 years old with B-cell acute lymphoblastic leukaemia (ALL), as well as for use in adults with a type of lymphoma. The new treatment “delivers a life-saving therapy to young patients with ALL who have not been successfully treated with existing therapies, and who have limited options left,” said Peter Bader at the University Hospital for Children and Adolescents in Frankfurt, Germany.

Novartis’s plans to expand production in Switzerland, which could create up to 450 jobs, followed a decision announced last month to begin producing cell and gene therapies in France.

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

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