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31 August 2017, 01:45 | Rex Hubbard
The logo of Swiss drugmaker Novartis AG is seen at its headquarters in Basel Switzerland
Tisagenlecleucel (Kymriah) is a personalized genetically-modified autologous T cell immunotherapy created to use a patient's own T cells to target and kill leukemia cells with CD19 antigens on the surface, according to a press release. In June, a clinical trial in China showed promise in treating another blood cancer, multiple myeloma, using reprogrammed T-cells in much the same way Kymriah does.
In its announcement, Novartis said it plans to make additional filings for Kymriah in the USA and EU this year, including applications with the FDA and European Medicines Agency for the treatment of adult patients with r/r diffuse large B-cell lymphoma.
ALL is an aggressive cancer that affects some 3,100 people aged 20 and younger each year in the United States, making it the nation's most common childhood cancer.
Most patients with ALL recover through other treatments such as radiation, chemotherapy and stem cells.
This type of immunotherapy, known as a CAR-T cell therapy, was known by the term CTL019 until now.
"We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer", FDA Commissioner Dr. Scott Gottlieb said in an FDA news release. It's these patients for whom Kymriah is intended. Once modified, the cells are infused back into the patient to kill the cancer cells.
The FDA based its decision on a clinical trial involving 63 patients with B-cell ALL.
However, Kymriah comes with the potential for severe side effects. Kymriah will carry a boxed warning for cytokine release syndrome, a potentially lethal systemic response to the activation and proliferation of CAR-T cells, causing high fever and potential for neurological problems.
Kymriah has a $475,000 price tag; however, patients who do not respond within a month of treatment will not be charged, according to Novartis. The drug's maker, Novartis, is required as a condition of approval to conduct a longer-term study of Kymriah's use, the agency said. Researchers hope that this will lead to further CAR-T treatments that can fight more complicated cancers such as pancreatic, breast, and brain cancer.
Other genetic therapies for cancer are also in the research pipeline.
Novartis plans additional filings for Kymriah in the USA and EU later this year, including applications with the FDA and European Medicines Agency, for the treatment of adult patients with r/r diffuse large B-cell lymphoma (DLBCL). "It's not a one-shot deal".
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