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Novartis' Kymriah first cell therapy to win USA green light

31 August 2017

The FDA has approved Novartis' cancer immunotherapy tisagenleucel (CTL019) under the Kymriah brand name, setting a $475,000 price per course for the chimeric antigen receptor T cell (CAR-T) therapy.

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.

Dr. Carl June, director of the center for cellular immunotherapies at University of Pennsylvania's Abramson Cancer Center, who pioneered the therapy, was still emotional an hour after receiving the news of the approval in an email. This is the first time the agency has greenlighted a gene therapy approach for use in the United States. The company also said it anticipates making additional filings beyond the US and European Union next year.

"As a breakthrough immunocellular therapy for children and young adults who desperately need new options, Kymriah truly embodies our mission to discover new ways to improve patient outcomes and the way cancer is treated", said Bruno Strigini, CEO of Novartis, the company that developed Kymriah.

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These re-engineered T-cells are then transfused back into the patient, where they can begin attacking leukaemia. Now 12, she has been free of leukemia for more than five years.

Kymriah is one type of so-called CAR-T cancer therapies.

CAR-T treatment uses gene therapy techniques not to fix disease-causing genes but to turbocharge T cells - immune system soldiers that cancer too often can evade.

The price per person is likely to be much higher when accounting for additional costs, such as drugs to prepare the patient for the treatment and medicines to control potential side-effects.

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Once the cancer-killing cells are reprogrammed, they are inserted back inside the patient, finding their target and multiplying. That's what a researcher is saying following the FDA's approval of America's first-ever treatment that genetically alters a person's cells to fight cancer. Until now, treatments have focused on bringing in drugs, surgery or radiation to weaken the cancer. In trials, the therapy achieved remission in 83% of patients.

Instead, it harnesses a patient's own immune cells, called T-cells and white blood cells, and trains them to recognize and fight cancer.

The safety and effectiveness of the Kymriah have been demonstrated in a clinical trial with 63 patients pediatric and young adults who had not responded to other treatments or had relapsed. However, even patients who achieve an initial response to standard therapy will eventually relapse, and the prognosis is extremely poor for these patients.

According to Gottlieb, the FDA has already granted more than 550 active investigational new drug applications related to gene therapy products, including 76 active investigational new drug applications related to CAR-T cell products like Kymriah. When his blood was analyzed, it turned out that every single CAR-T cell he had had descended from a single T-cell.

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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.

Novartis' Kymriah first cell therapy to win USA green light