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Novartis Gets FDA Nod For Leukemia Gene Cell Therapy

Novartis Gets FDA Nod For Leukemia Gene Cell Therapy

Novartis estimates about 600 patients a year would be eligible for the treatment, which belongs to a class of drugs known as vehicle T-cell therapies.

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

The Food and Drug Administration approved the therapy, called Kymriah, in children and young adults with acute lymphoblastic leukemia whose disease has come back in spite of previous treatments.

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

In this type of therapy, patients' own immune cells are modified ex vivo to include a gene for the auto protein, which directs them to attack leukemia cells carrying the CD19 antigen.

The drug has shown promising remission and survival rates in clinical trials, the FDA said.

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Novartis did not disclose how much it intends to charge for the game-changing drug, but analysts have projected it will likely cost hundreds of thousands of dollars for a course of treatment.

Novartis did not immediately respond to a question about the price.

Rather than wait for Novartis to announce a price, an advocacy group called Patients for Affordable Drugs has launched a pre-emptive strike, asking to meet with company officials to discuss a "fair" price for the therapy. The altered T-cells include a new gene that contains a protein called chimeric antigen receptor, or vehicle, that directs the T-cells to kill leukemia cells with the antigen CD19.

Shares in British biotech Oxford BioMedica jumped more than 10pc today after its partner on a world-first gene therapy for cancer won regulatory approval in the US. Gilead shares were up more than 5 percent on Wednesday as Kite is widely seen as likely to receive the next USA approval of a CAR-T therapy. This innovative immunocellular therapy will offer critically ill patients with an aggressive disease a new treatment option. The company did say that it's made an agreement with the US government to pay for the drug only when pediatric or young adult patients with the cancer respond to treatment by the end of their first month.

Kymriah comes with a boxed warning for cytokine release syndrome (CRS) which causes high fever and flu-like symptoms, as well as other severe side effects including serious infections, low blood pressure, acute kidney injury, fever, and decreased oxygen. Some 83 percent of those given the therapy were in remission within three months of treatment, the agency said. Researchers hope that this will lead to further CAR-T treatments that can fight more complicated cancers such as pancreatic, breast, and brain cancer.


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