Sunday, 22 October, 2017

A Groundbreaking, One-Time Cancer Treatment Is Poised to Save Thousands of Lives

AP License N  A Created 2015:07:09 10:22:28 Novel cancer treatment wins endorsement of FDA advisers
Patty Aguilar | 14 July, 2017, 10:26

The panel claimed the treatment would prove to be useful for children and young adults, between ages of 3 and 25 years, suffering from B-cell acute lymphoblastic leukemia.

A U.S. Food and Drug Administration advisory panel on Wednesday gave unanimous approval to what could soon be the first gene therapy to be marketed in the United States. Of 52 patients who results were analyzed, 83 percent had complete remission. It involves removing a patient's blood and essentially replacing it with a population of blood cells stacked with cancer-fighting immune cells known as T cells. Some patients in that study also had neurological problems, including seizures and delirium.

But despite the financial promise, the commercial barriers are high for developers of CAR-T therapies. After 12 months, 79 percent of them were still alive.

Neither the cancer therapy nor the follow-up is cheap.

An FDA advisory committee today unanimously recommended approval of the vehicle T-cell therapy tisagenlecleucel (CTL019) for pediatric and young-adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). It takes Novartis about 22 days to manufacture each patient's treatment. Health insurers have been implementing more restrictions to patient access lately, while costs of cancer drugs keep rising. The antibodies are spun out of donated blood, and infused into patients, whose risk of infection quickly returns to normal levels. The treatment was developed by the University of Pennsylvania and Novartis Corp and the FDA usually will back up the recommendations made by expert panels but is not compelled by it. No deaths were reported due to refractory CRS, though, and Novartis detailed how better experience managing CRS at clinical sites helped to make most CRS and neurotoxicity reversible.

Dr. Manny Esquilin works at Driscoll Children's Hospital. It will vote on whether to recommend FDA approval.

Last year, when Kite hired Christine Cassiano its new SVP of corporate communications and investor relations, she said that communication around CAR-T therapies is "about making it relatable to patients". If this goes well, Novartis may add more sites to ensure more patients can access CTL019 without traveling far.

People afflicted by B-cell acute lymphoblastic leukemia, the type of blood cancer Novartis's CTL019 is created to combat, are usually treated with methods such as radiotherapy, chemotherapy and bone-marrow transplants. About 85% are cured by chemotherapy, but those whose cancer returns have few options. The T-cells hone in on a protein called CD-19 that is found on the surface of most B-cells.

Novartis is also testing the drug in diffuse large b-cell Lymphoma (DLBCL), the most common form of non-Hodgkin lymphoma, as is Kite. As such, the treatment is tailored for each patient.

Other companies are also pursuing CAR-T cell strategies but have struggled with major complications. "This is a complex product". "Today is about advancing an exciting technology that has the potential to transform cancer treatment".

While the permanence of the manipulated cancer killers is good for eliminating the blood malignancy, it's bad for the immune system. Head to the Industry Snapshot for a closer look at which CAR-T specialists might be at the forefront of a greater biotech rally. "It's bad that it might be permanent". "It represents a paradigm shift in treating cancers", said Maloney, who is extensively involved in vehicle T-cell research but not in the Novartis product. First, a process specific to each patient is conducted where millions of immune system T-cells are removed and frozen at an approved medical center.

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