Cancer And The Immune System: FDA Panel’s Approval Of Pioneering T-Cell Therapy

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The availability of a pioneering T-cell therapy, the first treatment that genetically alters a patient’s cells, moved one step closer recently with FDA approval.

The T-cell therapy, created at the University of Pennsylvania and licensed to the pharmaceutical company Novartis, removes immune cells from the patient’s bloodstream, genetically reengineering them to recognize and kill cancer, multiplying the immune cells and infusing them into the patient’s body.

The therapy was approved for patients ages 3 to 25 with B-cell acute lymphoblastic leukemia that has relapsed or has not responded to standard treatments. The FDA is expected to announce its decision on making the protocol available in the next few months.

“This is an exciting advance that has, and will, save lives,” says Peter Yu, physician-in-chief of the Hartford HealthCare Cancer Institute. “It has been developed over the last four to five years and is part of the growing story of immunotherapy and cancer. We have learned that the immune system has so many weapons at its disposal.”

Yu expects the FDA will make the immunotherapy available at a limited number of sites across the United States, including the Memorial Sloan Kettering Cancer Center in New York, a Hartford HealthCare partner.

“Our doctors will work to identifyHartford HealthCare patients who might benefit from the treatments and facilitate accessing treatment at MSK if appropriate,|” he says.

Besides this new T-cell therapy, which will be marketed as Kymriah, other research studies into perfecting and implementing genetic therapy for cancer patients are ongoing, including a Memorial Sloan Kettering study that Hartford HealthCare patients can join here in Connecticut at the HHC Cancer Institute.

While Dr. Yu says “for the right patient, this treatment is going to be life-changing and life-saving,” the anticipated initial approval of T-cell therapy will be for use in patients whose disease has not been controlled by earlier treatments with conventional therapies, by which time the patient is often weaker and the disease harder to treat.

“They’re looking at the timing of its use,” he says of the T-cell therapy, “whether we can give it sooner so the patients have fewer side effects and it might be more effective.”

Earlier use may also help patients avoid such difficult treatments as bone marrow transplants.

Other studies are investigating the application of this new treatment to cancers such as leukemia not borne in the bloodstream. Approximately 90 percent of patients have so-called “solid tumors” of the lungs, ovaries or other organs. Dr. Yu says immunotherapy with reengineered T-cells may not be as effective in these cases because they may be less able to kill tumors when required to leave the bloodstream and locate their targets in other parts of the body.

“The question is, Can these re-engineered cells get into solid tumors?” says Dr. Yu. “Perhaps there are other kinds of immune cells that may be better subjects for genetic engineering to accomplish this.”

But in some cases, T-cell therapy may be more effective than chemotherapy. The treatment holds promise for use against glioblastoma, the aggressive type of brain cancer afflicting Sen. John McCain, says Dr. Yu. The brain typically has been a challenge for standard cancer treatments, but T-cell therapy may prove effective because immune cells are better able to enter the brain than chemotherapy drugs, which need to get through the blood-brain barrier that protects the brain from many drugs.

Meanwhile, some area leukemia patients at the Cancer Institute locations may soon be referred to Memorial Sloan Kettering to access the advanced, newly-approved therapy.

“T-cell therapy represents a continuation of the renaissance of blood and cancer care,” says Dr. Jeffrey Gordon, an oncologist with Hartford HealthCare Medical Group Oncology. “For my patients who may need this type of therapy, the relationship that Hartford HealthCare has with the Memorial Sloan Kettering Cancer Center opens up a door of opportunity for them. They can get the most up-to-date, technologically advanced therapy while still being connected to their care close to home.”

 

For more information on the Hartford HealthCare Cancer Institute, click here.

 


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