Novartis said on Tuesday it requested Food and Drug Administration
(FDA) approval for Kymriah for adult patients with relapsed or
refractory diffuse large B-cell lymphoma (DLBCL) who do not qualify
for a stem cell transplant.
Kymriah, a chimeric antigen receptor T cell (CAR-T) therapy, in
August won FDA approval against acute lymphoblastic leukemia in
patients up to 25 years old.
As it adds indications, Novartis expects Kymriah to eventually top
annual sales of $1 billion, but the drug has rivals in the DLBCL
setting. Earlier this month, the FDA approved Gilead's Yescarta for
patients with the disease who had failed other treatments.
"Kymriah represents a historic breakthrough in the evolution of
individualized immunotherapy and we are committed to bringing this
innovation to as many patients who may benefit as possible," Vas
Narasimhan, Novartis's chief medical officer and designated CEO,
said in a statement.
With CAR-T therapies, patients' immune cells are taken from their
bodies, genetically re-engineered to fight their cancer and then
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Novartis has set the price for Kymriah at $475,000 for young
patients with ALL, but the Basel-based company has pushed back
announcing the price for adult DLBCL patients until it wins FDA
Novartis also plans to submit an application for Kymriah with
European authorities this year, it said.
(Reporting by Silke Koltrowitz and John Miller; Editing by Michael
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