ZURICH (Reuters) - Swiss drugmaker Novartis is seeking U.S. regulators’ blessing for its Kymriah cell therapy to be used against a second form of blood cancer after winning initial approval for the treatment earlier this year.
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 reinfused.
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 approval.
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 Shields