Novartis's Kymriah wins EU approval for blood cancer treatment

[August 27, 2018]  By John Miller

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

The company aims to initially use the therapy in Europe to treat 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 patients, modifying them to better fight cancer, and then re-infusing them, is also approved in both indications in the United States, where it costs $475,000 for patients with ALL and $373,000 for DLBCL.

Novartis has been lauded for groundbreaking work on a last-ditch therapy for dying patients who failed other drugs but also raised eyebrows in the industry with a price that puts it among the most-expense treatments ever. It trails only a couple of gene therapies for ulta-rare diseases.

"Timing for Kymriah availability in each country will depend on multiple factors, including the onboarding of qualified treatment centers for the appropriate indications, as well as the completion of national reimbursement procedures," Novartis said in a statement on Monday.

Novartis said it is investing 90 million Swiss francs ($90.39 million) in a new Swiss facility to produce cell and gene therapies, and expects to deliver Kymriah from the site to European patients by the start of 2020.

In the first half, Kymriah had $28 million in sales in the United States, although the company hopes it will exceed $1 billion in sales as use of the medicine expands.

In the United States, Novartis has worked out agreements in which it is only reimbursed for Kymriah if patients with ALL are still responding by the end of the first month. For European pricing, it said talks are underway.

"Novartis is determining the list price and is committed to pricing Kymriah responsibly, in accordance with our company values," a spokeswoman said.

When the U.S. 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.

It now has a competitor, Gilead Sciences' Yescarta, for the patients with lymphoma in the United States, with European approval pending.

(Reporting by John Miller, Editing by Sherry Jacob-Phillips and Louise Heavens)

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