U.S. approves Novartis cell therapy for lymphoma

[May 02, 2018] By Deena Beasley

(Reuters) - U.S. regulators approved Novartis' cell therapy Kymriah for treatment of patients with a second type of blood cancer, large B-cell lymphoma, that has worsened despite two or more earlier lines of therapy, the Swiss drugmaker said on Tuesday.

The new indication puts Kymriah in direct competition with Gilead Sciences' Yescarta, which was approved by the U.S. Food and Drug Administration in October for treatment of adults with diffuse large B-cell lymphoma who have failed to respond to other treatments.

Both Kymriah and Yescarta are chimeric antigen receptor T-cell therapies, or CAR-Ts, which reprogram the body’s own immune cells to recognize and attack malignant cells.

Kymriah, given as a one-time treatment, was approved in August for patients up to age 25 with acute lymphoblastic leukemia, the most common form of childhood cancer in the United States.

For pediatric leukemia, Novartis priced Kymriah at $475,000 and said it would bill for the therapy only if patients responded within 30 days of treatment. For lymphoma patients, the Swiss company has matched Yescarta's $373,000 price and does not offer any outcomes-based price concessions.

Clinical trials have shown that a significant number of lymphoma patients may not respond to Kymriah until several months after treatment, making it difficult to measure outcomes within a defined period of time, said Pascal Touchon, head of cell and gene oncology at Novartis.

Kymriah is also approved for adults with high grade B-cell lymphoma and diffuse large B-cell lymphoma arising from follicular lymphoma.

The new FDA label for Kymriah notes that clinical trials showed that about 50 percent of patients responded to the treatment, and that the duration of those responses has not yet been determined.

Touchon said the 41 cancer treatment centers so far approved to administer Kymriah for pediatric leukemia are also certified for the lymphoma indication.

(Reporting by Deena Beasley in Los Angeles and Ishita Chigilli Palli in Bengaluru; editing by Jonathan Oatis and Leslie Adler)

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