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US FDA Panel Endorses First Gene Therapy Treatment For Cancer

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In the latest for cancer treatments, a US based pharmaceuticals company, Novartis has developed the first gene therapy treatment for B-cell Acute Lymphoblastic Leukemia (ALL).

Novartis AG's pioneering cancer drug won the backing of US Food and Drug Administration panel on Wednesday, 12 July.

The treatment is the first ever therapy that helps a patient fight cancer by genetically altering one’s own cells and transforming them into a ‘living drug’ as per the scientists. It will empower the immune system to eventually keep cancer out of the body.

An advisory panel to the Food and Drug Administration voted 10-0 that the drug, tisagenlecleucel, should be approved to treat patients with relapsed B-cell ALL, the most common form of cancer seen in children and young adults aged 3-25.

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How Does It Work?

The drugs are made by extracting and isolating a patient's T cells, genetically engineering them to recognise and target specific cancer cells, and then infusing them back into the patient.

Novartis said the entire process will take 22 days by the time it is launched.

A clinical trial of Novartis's drug showed that 83 per cent of patients who had relapsed or failed chemotherapy, achieved complete or partial remission three months post infusion.

Patients with ALL who fail chemotherapy typically have only a 16 to 30 percent chance of survival.

If approved, the drugs, which are infused just once, are expected to cost up to $5,00,000 and generate billions of dollars for their developers.

Success would also help advance a cancer-fighting technique that scientists have been trying to perfect for decades and lift the broader field of cell therapy.

The FDA is not obliged to follow the recommendations of its advisers, but typically does so.

If approved, this will be the first ever gene therapy treatment to be available for cancer. The agency is expected to rule on the drug by the end of September.

(With inputs from Reuters)

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Topics:  Cancer Treatment   Gene Therapy 

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