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Novartis receives US FDA approval for cell therapy to treat lymphoma

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

US regulators have 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.

The new indication puts Kymriah in direct competition with Gilead Sciences’ Yescarta, which was approved by the US Food and Drug Administration (US FDA) 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 reprogramme the body’s own immune cells to recognise 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 paediatric 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 per cent of patients responded to the treatment, and that the duration of those responses has not yet been determined. Touchon said the 41 cancer treatment centres so far approved to administer Kymriah for paediatric leukemia are also certified for the lymphoma indication.

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