Novartis wins EU approval for blood cancer therapy Kymriah

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.

Additionally, it has a deal with French contract manufacturer CELL for CURE 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.

In the first half, Kymriah had $28 million in sales in the United States, although the company hopes it will eventually exceed $1 billion in annual revenue as use of the medicine expands. In the United States, Novartis has worked out agreements in which it is reimbursed for Kymriah only if young patients with ALL are still responding by the end of the first month.

For European pricing Touchon said it was too early to say whether there would be similar types of systems or processes as the one Novartis has in the United States. "We are extremely open," he said.
When the US Food and Drug Administration approved it in August 2017, Kymriah was hailed as the first of a new type of gene-modifying immunotherapy for blood cancer.

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