US FDA recommends new genetic treatment to fight cancer

Cambridge Thomson Reuters

"If approved, it will be the first-ever true gene therapy treatment made available to the U.S. population and will help accelerate the speed at which we will see even more gene-based therapies come to fruition".

A panel of experts which advises the Food and Drug Administration (FDA) has unanimously voted to recommend approval of a pioneering cancer therapy from Novartis, setting up a likely approval for the first-of-its-kind treatment.

The treatment will be suitable for young people who have not been able to improve on conventional treatments, or those who have suffered a relapse that has caused the recurrence of leukemia after complete recovery, according to the report.

The therapy could be the first of a wave of treatments custom-made to target a patient's cancer.

The new therapy, called chimeric antigen receptor T cell (CAR-T) therapy, provides new hope that the disease won't just be treated, but cured. The FDA doesn't have to follow the advice of the advisory committee, but it often does.

The Swiss drug company Novartis AG, which developed the treatment, is expected to receive a decision on CTL019 by October from the FDA in October, according to Bloomberg.

"When fully commercialized, this [CTL019] therapy will no doubt save the lives of many children and young adults who have had no other effective therapy for relapsed and refractory B-cell acute lymphoblastic leukemia [ALL]", said Dr. John Maris, a pediatric oncologist at The Children's Hospital of Philadelphia.

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"This review by the FDA of CAR-T therapy is a major milestone in the successful treatment of cancer", noted John Walter, CEO and president of ACGT. Called CAR-T, it involves removing immune cells from a patients' blood, reprogramming them to create an army of attack cells and putting them back into the patient.

The unanimous recommendation from the Oncologic Drugs Advisory Committee means the treatment could be approved by the FDA by the end of September, forging a new path in the immunotherapy frontier. The new treatment retrains the patient's immune system to kill tumor cells.

"When other organizations, including the (National Institutes of Health), considered gene therapy too risky, ACGT believed in the science and funded us when no one else would". The company hasn't disclosed how many patients in its trials needed immunoglobulin after treatment.

Once the material of the cells changed, they are fed back to patients. Experts say the approval will pave the way for a new era of gene-based medicines, which has shown promise in treating a wide range of diseases.

Millions T-cells (a type of immune cell) are from removed the patient's blood.

David Maloney, medical director for cellular immunotherapy at Fred Hutchinson Cancer Research Center in Seattle, said he was elated that the field is moving forward. Any lifting of the reservations on the long-term side effects of such support.

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". This is also why companies like GE Healthcare are jumping into cell therapy manufacturing to offer companies like Novartis, Kite, and Juno large-scale production services. Seven dropped due to an insufficient batch of CAR-T formulation, five did not reach a 3-month followup, and four were still in the process of infusion at the data cutoff time point.

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