PHILADELPHIA (WPVI) -- The Food and Drug Administration has expanded its approval for Kymriah, the personalized cancer immunotherapy developed at the University of Pennsylvania.
The new approval is for adult patients with non-Hodgkins lymphoma - large B-cell lymphoma which doesn't respond to 2 types of standard therapy.
Today's approval includes treatment of diffuse large B-cell lymphoma (DLBCL) - the most common form of non-Hodgkin's lymphoma - as well as high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
DLBCL affects approximately 30 percent of patients with NHL, and there are an estimated 27,000 newly diagnosed cases of DLBCL in the U.S. each year.
"This is an exciting event - seeing this lifesaving therapy become available widely to a large patient population with an unmet medical need," said Stephen J. Schuster, MD, director of the Lymphoma program at Penn's Abramson Cancer Center.
Kymriah was approved in August 2017 for B-cell acute lymphoblastic leukemia (ALL).
Penn and Novartis researched, developed, and market Kymriah.
A study on Kymriah presented earlier this year showed an overall response of 53 percent, with 40 percent of the 81 patients achieving a complete response.
While the drug can be a life-saver, it can also have serious side effects.
58 per cent of the patients in the DLBCL trials experienced a side effect called cytokine release syndrome (CRS).
Novartis will create a registry to follow patients for 15 years after being treated to monitor their progress and any potential, future side effects.
Jefferson Health reported another milestone in immunotherapy today - success using CAR T cell treatment on colorectal cancer cells in lab mice.
Researchers at the Sidney Kimmel Cancer Center say the CAR T cell successfully killed tumors and prevented metastases in mouse models of the disease.
"Colorectal cancer rates are exceptionally high in our region, and advanced stage disease is difficult to treat," said Karen Knudsen, PhD, Director of the Sidney Kimmel Cancer Center.
"We are optimistic about the pre-clinical results," she added.
The target in the trials is also seen in several highly-deadly cancers, including pancreatic and esophageal cancer.
The next step is phase 1 safety trials in humans.
No date for that has been set.
Two major advances for CAR T-cell cancer treatment
Kymriah immunotherapy gets FDA OK for non-Hodgkins' lymphoma
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