FDA approves lymphoma drug tested in Boston

BOSTON -- The Food and Drug Administration gave the green light on Wednesday to a new cancer treatment that was tested in Boston.

Gilead Science's Yescarta is the first chimeric antigen receptor (CAR) T-cell therapy for adult cancers. The drug can now be used to treat adults with advanced non-Hodgkin lymphoma.

"Each dose of Yescarta is a customized treatment created using a patient’s own immune system to help fight the lymphoma. The patient’s T-cells, a type of white blood cell, are collected and genetically modified to include a new gene that targets and kills the lymphoma cells. Once the cells are modified, they are infused back into the patient," according to the FDA.

The safety and efficacy of Yescarta were established in a multicenter clinical trial of more than 100 adults with refractory or relapsed large B-cell lymphoma. The complete remission rate after treatment with Yescarta was 51%.

Dana-Farber/Brigham and Women's Cancer Center was the only facility in the northeast to be part of the clinical trial and is one of a few locations certified to offer this new therapy nationwide.

"The successful development of CAR T-cells as a therapy for cancer, on the heels of the success of immune checkpoint blockade drugs, is a testament to the progress we have made in understanding how our immune system is regulated and how cancer evades the immune system," said Caron A. Jacobson, MD, Medical Director of the Immune Effector Cell Therapy program at Dana-Farber/Brigham and Women's Cancer Center.  "It is a perfect example of how basic science research can fuel clinical progress. Now we need to take what we can from the clinic back to the laboratory to make this therapy even better."

Fox Business reports Yescarta costs $373,000.

Gilead Chief Executive John Milligan said in a statement the approval marks "an important day for patients with relapsed or refractory large B-cell lymphoma who have run out of options and have been waiting for new treatments that may help them in their fight against cancer."

The therapy will have $1.7 billion in world-wide sales in five years, according to EvaluatePharma, a market-research firm.

Cox Media Group