Tags: fda | approves | gene-therapy | non-hodgkins

FDA Approves 2nd Cancer Treatment Using Gene Therapy for Non-Hodgkins Lymphomas

FDA Approves 2nd Cancer Treatment Using Gene Therapy for Non-Hodgkins Lymphomas

(Dreamstime)

By    |   Friday, 20 October 2017 09:23 AM

The FDA has approved a second cancer treatment using gene therapy, and the first to target non-Hodgkins lymphomas.

The therapy, Yescarta or axicabtagene ciloleucel, will be used on adult patients with certain types of large B-cell lymphoma after other treatments fail, CNN reported on Thursday.

The cost to treat a patient is $373,000, NBC News reported.

Non-Hodgkin lymphomas account for roughly four percent of all cancers in the United States and an estimated 72,000 new cases are diagnosed each year, CNN said. About half of all patients with large B-cell lymphoma relapse or become resistant to current treatments, which may include chemotherapy, stem cell transplants, and immunotherapy, the broadcaster noted.

In August, the FDA approved a different but similar treatment for B-cell acute lymphoblastic leukemia in patients under the age of 25 who have not been helped by other treatments, NBC News noted.

A statement from the U.S. Food and Drug Administration said each dose of Yescarta will be customized using the patient's own immune system to help fight the lymphoma. The patient's T-cells, a type of white blood cell, are collected, genetically modified to include a new gene that targets and kills the lymphoma cells, and infused back into the patient.

"The approval of Yescarta brings this innovative class of CAR-T cell therapies to an additional group of cancer patients with few other options – those adults with certain types of lymphoma that have not responded to previous treatments," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.

The safety and efficiency of Yescarta were established in a multicenter clinical trial of more than 100 adults with refractory or relapsed large B-cell lymphoma, the FDA said.

"Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases," said FDA commissioner Dr. Scott Gottlieb.

"In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer. This approval demonstrates the continued momentum of this promising new area of medicine and we’re committed to supporting and helping expedite the development of these products."

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The FDA has approved a second cancer treatment using gene therapy, and the first to target non-Hodgkins lymphomas.
fda, approves, gene-therapy, non-hodgkins
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2017-23-20
Friday, 20 October 2017 09:23 AM
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