FDA approves breakthrough treatment for dire cancers

FDA approves breakthrough treatment for dire cancers

FDA approves breakthrough treatment for dire cancers

The United States approved the first gene therapy in the nation on Wednesday - a treatment that uses a patient's own immune cells to fight childhood leukaemia.

The treatment was approved for certain children and young adult up to the age of 25 who suffer from a form of acute lymphoblastic leukemia (ALL) - a cancer of blood and bone marrow that is the most common childhood cancer in the United States.

The new treatment involves removing immune cells called T cells from a patient's blood and giving them a gene for a protein called a chimeric antigen receptor, or vehicle, that directs the T cells to target leukemia cells.

"We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer", said FDA Commissioner Scott Gottlieb, M.D.in Wednesday's announcement.

"There has been an urgent need for novel treatment options that improve outcomes for patients with relapsed or refractory B-cell precursor ALL", Novartis, the drug company that makes Kymriah, said in a statement. Patients may be at increased risk for infections for a prolonged period of time after infusion as the treatment may also destroy normal B cells.

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"Through our collaboration with Novartis, we are creating the next wave of immunocellular cancer treatments, and are eager to progress CAR-T therapy in a host of hematologic and other cancer types", said Carl June, MD, Professor of Immunotherapy, Director of the Center for Cellular Immunotherapies in Penn's Perelman School of Medicine.

The disease is the most common type of childhood cancer in the USA, making up 25 percent of cancer diagnoses for children under 15 years old, according the National Cancer Institute. More than half were children and teens.

Potential side effects of Kymriah include cytokine release syndrome, a bodily response characterized by high fever and flu-like symptoms. "At the FDA, we're committed to helping expedite the development and review of groundbreaking treatments that have the potential to be life-saving", he said. Novartis said it expects between 30 and 35 centers to be certified to offer the treatment by the end of the year. After three months of treatment, 83 percent of the patients remained cancer-free. The FDA also released a treatment for these side effects on Wednesday.

In the main study that informed the advisory committee's decision in July, roughly half of 68 patients experienced high-grade CRS, though none died from it.

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