Gilead cancer immunotherapy wins US approval with 373,000 dollars price

A new therapy for a type of lymphoma developed by Kite Pharma, which was acquired by Gilead Sciences Inc, won U.S. approval on Wednesday, marking the second approval for this potentially revolutionary approach to fighting cancer.

Gilead said the price for the therapy with the one-time administration would be $373,000.

Gilead Sciences shares rose almost 4 percent to $83 in extended trading.

The therapy, to be sold under the brand name Yescarta, is the second in a new class of cancer treatments known as chimeric antigen receptor T-cell therapy, or CAR-T, which reprograms the body's own immune cells to recognize and attack malignant cells.

The first drug in the class, Novartis AG's Kymriah, costs about $475,000 for the one-time treatment. It was approved in August for B-cell acute lymphoblastic leukemia, the most common form of childhood cancer in the United States.

Yescarta is approved to treat adults with relapsed or refractory large B-cell lymphoma, a type of non-Hodgkin lymphoma.

"The approval of Yescarta brings this innovative class of CAR-T cell therapies to an additional group of cancer patients with few other options," Peter Marks, the Food and Drug Administration's director of biologics evaluation, said in a statement.

Potentially curative CAR-T therapies are poised to revolutionize blood cancer treatment, offering therapies tailored to the individual patient.

The treatments are made from a patient's own infection-fighting cells. They are extracted, genetically engineered to recognize cancer cells, and infused back into the patient, where they form an army to attack and destroy malignant cells, potentially for years.

"Gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer," FDA Commissioner Scott Gottlieb said in a statement.

In a pivotal clinical trial of more than 100 adults, 51 percent of patients treated with Yescarta achieved complete remission, far higher than what is typical with current standard-of-care treatments.

"We conducted extensive research with commercial and government payers, as well as targeted cancer centers, to set a price that reflects the value represented by this innovation, and that supports accessibility of this personalized therapy," Gilead spokeswoman Amy Flood said in an emailed statement.

Gilead agreed in August to pay $180 a share, or about $12 billion, for Kite two days before Kymriah won U.S. approval, boosting confidence in the entire CAR-T class.

Similar CAR-T treatments are being developed by Juno Therapeutics Inc, bluebird bio Inc and others.

(Reporting by Toni Clarke and Bill Berkrot; Additional reporting by Deena Beasley in Los Angeles; editing by Leslie Adler and Diane Craft)