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Novartis wins EU approval for blood cancer therapy Kymriah

Written by: | | Dated: Monday, August 27th, 2018


ZURICH (Reuters) – Novartis has received European approval for Kymriah, its gene-modifying therapy for blood cancer, but said its introduction would vary from country to country as the Swiss drugmaker works out payment details and builds manufacturing capacity.

The company aims initially to use the therapy in Europe for young people up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL), and later for adult patients with diffuse large B-cell lymphoma (DLBCL).

The one-time therapy — which works by removing disease fighting T-cells from individual patients, modifying them to attack cancer, and then re-infusing them — is approved in both indications in the United States, where it costs $475,000 for patients with ALL and $373,000 for DLBCL.

The treatment is aimed at patients who have not been helped by other drugs.

Novartis is investing 90 million Swiss francs ($90.4 million) in a new Swiss facility to produce Kymriah, and expects this site to deliver the therapy to European patients by the start of 2020.

Additionally, it has a deal with French contract manufacturer CELLforCURE as well as Germany’s Frauenhofer Institute, which, along with Novartis’s existing site in New Jersey, will support manufacture of the custom-made therapy for European patients.

“This is an individualized therapy made for one patient only,” Pascal Touchon, Novartis’s global head of cell and gene therapies, said in an interview.

“It creates unique challenges from a capacity ramp-up point of view that do not exist with other types of drugs.”

He declined to say how many patients the company hopes to have capacity to treat by 2020.


Reuters source:


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