Gene Therapy Cancer Treatment Given Federal Approval

Mitchell Carson

The FDA approved the first-ever gene therapy in the USA on Wednesday.

USA regulators approved a revolutionary new treatment from Novartis that modifies the body's own immune-system cells and reinjects them to treat, and in many cases cure, patients with deadly blood cancers who have run out of other options.

"We're excited and proud to have moved this vehicle therapy, in collaboration with Novartis and CHOP, through all phases of development and clinical trials, established its efficacy, and now extended its reach to children across the country under this FDA approval", he added.

Shares of Juno Therapeutics Inc, which past year reported a handful of patient deaths during trials of its CAR-T therapy, were down 8.9 percent at $39.92.

Michelle Denault
Michelle Denault

Known as CAR-T therapy, the Novartis treatment is the first of several such drugs under development or review.

Although this move has been widely met with optimism, the treatment's heavy price tag has also attracted its fair share of criticism and left many people pointing towards the "completely broken" drug pricing system in the US.

The treatment, called Kymriah, aims to give some patients a second chance after first-line drugs have failed.

Novartis will create a registry to follow patients for 15 years after being treated to monitor their progress and any potential, future side effects.

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Tisagenlecleucel is a genetically modified autologous T-cell immunotherapy. The overall remission rate within three months of treatment was 83 percent. Satwani - who hasn't delivered the CAR-T therapy but is heading up the program at Columbia, one of the 32 sites Novartis will use - said patients would need to be monitored closely for about a month, meaning they'd need to be less than a two-hour drive from their hospital. This also applies to those patients of this particular leukaemia who have suffered a relapse of the cancer.

The FDA's move to approve the auto T-cell therapy, which will be marketed under the name "Kymriah" by Novartis Pharmaceuticals, opens the door to a new era of cancer medicine, and medicine more broadly. For others, Kymriah serves as a "bridge to transplant", keeping them alive longer enough to undergo this therapy.

"This transformational therapy for patients is the result of true collaboration between industry, academia, healthcare professionals, patients and caregivers", said Bruno Strigini, CEO, Novartis Oncology. Kite, which was recently acquired by Gilead Sciences, is expected to hear back from the FDA about its treatment for aggressive B-cell non-Hodgkin lymphoma by November.

Kymriah does have side effects, causing cytokine release syndrome, a systemic response to the proliferation of auto T-cells that can cause flu-like symptoms such as a high fever, and neurological events.

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The treatment is the first of its kind approved in the U.S. Researchers are trying to get the approach to work for solid tumors. This allows the cells to replicate quickly and zero in on cancer cells, fighting the disease for years.

Shares of Bluebird Bio Inc, which is developing a promising CAR-T treatment, were up 11.1 percent at $113.73. And past year, Juno said five people in its clinical trials had died, all from cerebral edema.

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