NVS Novartis AG

   By Donato Paolo Mancini 
 

Novartis AG's (NOVN.EB) cell-therapy cancer drug Kymriah has been approved by the U.S. Food and Drug Administration for use in patients with relapsed large B-cell lymphoma that haven't responded to first-line treatment.

Kymriah, a type of CAR-T drug, was the first of its kind to receive additional approval for therapeutic use from the U.S. regulator, the Swiss pharmaceutical company said Tuesday.

Kymriah was first approved last year for treatment of relapsing, under-25 acute lymphoblastic leukemia patients. It is priced at $475,000.

CAR-T, which stands for chimeric antigen receptor T-cell therapy, is a form of personalized immunotherapy. The treatment works by extracting a patient's immune blood cells, and modifying them to fight off cancer. The cells are then re-injected into the patient's bloodstream to attack the cancer.

First-quarter sales of Kymriah amounted to $12 million, Novartis said last month. Tuesday's FDA approval could buoy sales of the drug in the second quarter.

The approval puts Novartis in competition with Yescarta, a drug made by Gilead Sciences Inc. (GILD) that was approved late last year for the same therapeutic indication and is priced at $373,000.

Write to Donato Paolo Mancini at donatopaolo.mancini@dowjones.com

(END) Dow Jones Newswires

May 02, 2018 02:34 ET (06:34 GMT)

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