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'Revolutionary' cancer drug using genetically modified cells approved
A revolutionary cancer therapy that supercharges a patient's immune cells to hunt and destroy cancer cells has been approved for use in Australia, ushering in a new era in medicine.
Desperate patients with aggressive blood cancers who have not responded to conventional treatments have been heading overseas to receive a shot of the "custom-made" drug and experiencing "miraculous" results.
In a last-ditch attempt, Daniel Clarke, 45, and his family dropped everything and travelled to Boston so that he could undergo CAR-T therapy for diffuse large B cell lymphoma (DLBCL). One month later, scans showed the cancer was gone.
"I felt like someone had just handed my life back to me," Mr Clarke, a Qantas engineer from the Sutherland Shire, said.
"It has all happened so quickly. Late September we came here not knowing what to expect, hoping for the best, fearing the worst. Then come November I was in complete remission."
The Therapeutic Goods Administration (TGA) has approved CAR-T therapy - the first of its kind - for use in paediatric and young adult patients with B-cell precursor acute lymphoblastic leukaemia (ALL) and adult patients with DLBCL who have failed other treatments, including chemotherapy.
CAR-T therapy involves extracting a patient's own beleaguered immune cells and genetically re-engineering them before infusing them back into the body. The single-shot "living drug" has generated enormous excitement in the medical world.
TGA's approval was based on two global clinical trials that showed an incredible 62 per cent relapse-free survival rate at 24 months in paediatric ALL patients and a 43 per cent probability of overall survival at 18 months in adult DLBCL patients.
Pharmaceutical giant Novartis, which owns the therapy, commercially known as Kymriah, is increasing lab capabilities to meet growing demand, with Europe, Canada and Switzerland giving their stamp of approval.
"We are focused on ramping up capacity at our US and Switzerland facilities and we recently announced a collaboration agreement for additional manufacturing capacity with Fraunhofer (Germany) and CellforCure (France)," Lauren Carey from Novartis said….
https://www.smh.com.au/national/revolutionary-cancer-drug-using-genetically-modified-cells-approved-20181217-p50msk.html
CAR T Cells: Engineering Patients’ Immune Cells to Treat Their Cancers
For years, the foundations of cancer treatment were surgery, chemotherapy, and radiation therapy. Over the last two decades, targeted therapies like imatinib (Gleevec®) and trastuzumab (Herceptin®)—drugs that target cancer cells by homing in on specific molecular changes seen primarily in those cells—have also cemented themselves as standard treatments for many cancers.
But over the past several years, immunotherapy—therapies that enlist and strengthen the power of a patient’s immune system to attack tumors—has emerged as what many in the cancer community now call the “fifth pillar” of cancer treatment.
A rapidly emerging immunotherapy approach is called adoptive cell transfer (ACT): collecting and using patients’ own immune cells to treat their cancer. There are several types of ACT (see “ACT: TILs, TCRs, and CARs”), but, thus far, the one that has advanced the furthest in clinical development is called CAR T-cell therapy.
Until recently, the use of CAR T-cell therapy has been restricted to small clinical trials, largely in patients with advanced blood cancers. But these treatments have nevertheless captured the attention of researchers and the public alike because of the remarkable responses they have produced in some patients—both children and adults—for whom all other treatments had stopped working.
In 2017, two CAR T-cell therapies were approved by the Food and Drug Administration (FDA), one for the treatment of children with acute lymphoblastic leukemia (ALL) and the other for adults with advanced lymphomas. Nevertheless, researchers caution that, in many respects, it’s still early days for CAR T cells and other forms of ACT, including questions about whether they will ever be effective against solid tumors like breast and colorectal cancer.
The different forms of ACT “are still being developed,” said Steven Rosenberg, M.D., Ph.D., chief of the Surgery Branch in NCI’s Center for Cancer Research (CCR), an immunotherapy pioneer whose lab was the first to report successful cancer treatment with CAR T cells.
But after several decades of painstaking research, the field has reached a tipping point, Dr. Rosenberg continued. In just the last few years, progress with CAR T cells and other ACT approaches has greatly accelerated, with researchers developing a better understanding of how these therapies work in patients and translating that knowledge into improvements in how they are developed and tested.
“In the next few years,” he said, “I think we’re going to see dramatic progress and push the boundaries of what many people thought was possible with these adoptive cell transfer–based treatments.”
https://www.cancer.gov/about-cancer/treatment/research/car-t-cells
CHIMERIC ANTIGEN RECEPTOR (CAR) T-CELL THERAPY
https://www.lls.org/treatment/types-of-treatment/immunotherapy/chimeric-antigen-receptor-car-t-cell-therapy
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just understand that's a pretty huge step in curing cancers
immunotherapy
genetically enhancing our immune cells to target and fight the cancer