Health Care

FDA Panel Recommends Approval for Novartis CAR-T Cell Therapy

FDA Panel Recommends Approval for Novartis CAR-T Cell Therapyā€¯

Those patients typically have a grim prognosis, but in the pivotal trial testing the therapy in nearly a dozen countries, 83 percent of patients went into remission.

Yet it also causes collateral damage. Once infused back into the patient, the cells reproduce at a fierce pace to attack the cancer.

If Novartis can claim approval in ALL and follow-up indications such as diffuse large B-cell lymphoma (DLBCL), analysts reckon CTL019 could become a $1bn-plus product.

"The therapy is being given to people who would be dead if they didn't receive it, and they would be dead within a pretty short period of time", said Edmund Waller, director of Emory University's stem cell and immune therapy division.

Neither the cancer therapy nor the follow-up is cheap.

The therapy could be the first in a wave of treatments that are custom-made to target cancer using a new technology known as CAR-T, or chimeric antigen receptor T-cell therapy. At least three patients died with various infections - including viral, bacterial and fungal - more than a month after the drug's one-time infusion, according to the brief.

In a unanimous vote on 12 July, the panel determined that the benefits of the treatment, called CAR-T therapy, outweigh its risks. "Coverage determination will be made on clinical grounds".

"This is probably the most exciting thing I have seen in my lifetime", said Tim Cripe, chief of hematology and oncology at Ohio State University's Nationwide Children's Hospital.

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The committee has asked Novartis to commit to 15 years of follow-up, given the therapy is following a fast-track approval and no long-term data is available yet.

The panel has recommended this treatment for B-cell acute lymphoblastic leukemia for children and young adults, ages 3 to 25, after multiple studies brought long remissions and possibly some cures to patients.

The vote also underscores ODAC's ingrained acceptance of moderate risk when it comes to treating patients dying of cancer. These include the possible risk that the virus used to engineer the cells could acquire the ability to replicate, or that improper insertion of the foreign gene could turn the T cells cancerous.

If the FDA accepts the recommendation, which is likely, the treatment will be the first gene therapy to reach the market.

Patients with ALL who fail chemotherapy typically have a 16 to 30 percent chance of survival. Of 68 young people receiving it, 52 of them had an excellent response nearly immediately, with their cancer disappearing within the first three months. "This is a complex product". But unlike traditional gene therapy, the new treatment doesn't replace disease-causing genes with healthy ones. "Shire continues to explore ways to address patient demand today and as it looks toward the future". Companies including Merck & Co Inc and Bristol-Myers Squibb Co are logging billions of dollars in annual sales of drugs known as "checkpoint inhibitors" that fight cancer by removing a brake on the body's immune system. "It's bad that it might be permanent".

The drug enables patients' own immune cells to recognize and kill the source of the cancer: a different immune cell gone awry.

Fatalities due to cerebral oedema have occurred with other CAR-T therapies however - notably Juno Therapeutics' JCAR015 which was discontinued in March and another candidate from Kite Pharma - and as a result the safety of CTL019 had been expected to come under close scrutiny.



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