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Gilead Sciences CAR-T cell therapy for lymphoma wins US FDA approval

The U.S. Food and Drug Administration approved Gilead Sciences Inc.'s gene therapy Yescarta to treat adult patients with certain types of relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.

Indications for the drug include diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma and diffuse large B-cell lymphoma arising from follicular lymphoma. The drug is not indicated for the treatment of patients with primary central nervous system lymphoma.

Yescarta is a chimeric antigen receptor T cell, or CAR-T cell, therapy, which is manufactured specifically for each individual patient and uses patients' own immune cells to kill cancer cells.

Kite Pharma, which developed the treatment, was acquired by Gilead Sciences for $11.9 billion in October.

Yescarta is the second CAR-T cell therapy to win FDA approval after Novartis AG's Kymriah got the green light in August for treating acute lymphoblastic leukemia.

The therapy has a boxed warning in its product label regarding the risks of cytokine release syndrome and neurologic toxicities. A risk evaluation and mitigation strategy has been approved by the FDA for Yescarta, which will inform and educate healthcare professionals regarding risks associated with the therapy.

Yescarta will have a list price of $373,000 in the U.S., lower than Kymriah's $475,000 price tag. The drug will be manufactured at Kite's facility in El Segundo, Calif.

Gilead said it expects marketing approval for Yescarta from the European Medicines Agency in the first half of 2018.