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Top Headlines on CAR-T Cell Therapy

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From FDA concerns to a potential new drug, CAR-T cell therapies were dominating oncology headlines last week.

Blood cancer treatments — and one treatment type, in particular — were the point of much discussion last week. The FDA said that it is investigating instances of secondary malignancies in patients with blood cancers treated with CAR-T cell therapy. Also, the drug manufacturer for a novel CAR-T cell therapy submitted an application to introduce the treatment into the United States market.

Blood cancers will continue to be a hot topic this week, as later in the week we’ll be covering the American Society of Hematology Annual Meeting. And before that, we’ll also be covering the San Antonio Breast Cancer Symposium.

Chance or CAR-T: Expert Weighs in on FDA Investigation

One of the biggest headlines in the cancer space last week was that the Food and Drug Administration (FDA) announced that they are investigating instances of T-cell malignancies — such as CAR-positive lymphoma — occurring in patients with blood cancers that were treated with CAR-T cell therapy.

CAR-T cell therapy is a newer type of blood cancer treatment that involves extracting patients’ blood and reengineering their immune T cells to find and fight cancer. Those new T cells are then multiplied and infused back into the patient. Since the first CAR-T cell product was approved in 2017, this treatment modality has drastically improved outcomes for patients with certain types of blood cancers.

It’s worth mentioning that the FDA’s Nov. 28 report about T-cell malignancies did not definitively say that CAR-T cell therapies are directly causing secondary diseases. They also did not mention the frequency at which these T-cell malignancies are occurring. I spoke with Dr. John Lister, who said that perhaps it’s the manufacturing process that could be the root cause, but perhaps it is also just chance, as research has shown that many patients with cancer hold a higher risk of developing a second cancer. For now, we’re just going to have to wait and see what further data tells us.

FDA Biologics License Application Filed for Obe-Cel for Adult R/R B-ALL

Also in CAR-T cell therapy news, last week a pharmaceutical company submitted a Biologics License Application to the FDA for their CAR-T cell therapy, obe-cel to be used for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL).

When a pharmaceutical company files a Biologics License Application to the FDA, they’re essentially asking the agency to allow them to bring the drug to the market. The company submitting the drug must provide the FDA with multiple pieces of information, including findings from preclinical and clinical studies showing that the drug is safe.

In this instance, the pharmaceutical company cited data from the FELIX study, from which, early data showed that 76% if patients responded to the therapy, including 54.3% who had a complete response, meaning that their disease essentially disappeared. Now, updated findings from the trial will be presented at the upcoming ASH Annual Meeting.

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