Novartis's new $475000 cancer drug among most expensive ever

by Noah Mcgee September 1, 2017, 1:37
Novartis's new $475000 cancer drug among most expensive ever

Pharma giant Novartis on Wednesday won highly anticipated U.S. approval for the first of a new type of potent gene-modifying immunotherapy for leukemia, an exhorbitantly priced treatment that nevertheless marks the start of a potential new treatment approach for some cancers. The overall remission rate within three months of treatment was 83 percent, the company said.

"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.

About 3,100 Americans aged 20 and younger are diagnosed with acute lymphoblastic leukemia each year, according to the National Cancer Institute.

Novartis Pharmaceuticals, the company behind the treatment, is setting the price for this one-time treatment using "CAR-T cells" at $475,000.

Regulators in the United States have approved the first gene therapy treatment for leukemia, which comes with a price tag of $475,000 (N144.87 million).

"It's a new method of treating cancer that I think we will successfully further exploit over the next decade".

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"It is critical to have a realistic outlook and to have a measured response to the Novartis CAR-T approval". It's also known as CAR-T cell therapy.

The FDA said hospitals and clinics must become certified to distribute the treatment, meaning they are prepared to recognize and treat CRS and other potentially fatal neurological events. The Swiss drugmaker intends to apply for approval in diffuse large b-cell lymphoma later this year, a larger patient population, and will price Kymriah differently depending on the indication.

In CAR-T cell treatment the Patients own blood cells or immune cells are filtered out and sent to lab where they get reprogrammed into a CAR (chimeric antigen receptor) which makes the T cells super active or turbocharge and after that the T cells are again infused into the body so that they could combat with the cancerous cells more efficiently. It carries a boxed warning for cytokine release syndrome (CRS), which is a systemic response to the activation and proliferation of auto T-cells causing high fever and flu-like symptoms, and for neurological events. But speaking earlier this year to The New York Times, drug industry analysts estimated that individualized therapies could cost more than $300,000. Now Novartis has proved it is possible for one therapy to succeed, this proves others will succeed too, and this adds competition to the mix.

The firm also highlighted the "urgent need" for new treatment options that boost outcomes for patients with relapsed or refractory (r/r) B-cell precursor ALL, whose prognosis is poor. Salvage therapies for children with relapsed ALL are highly toxic and only work in about 50 percent of relapsed patients.

For now, Kymriah is only available to a small subsection of cancer patients.

Another group, the Campaign for Sustainable Rx Pricing said in a statement that while the "science behind Kymriah is revolutionary, the business decision to price it at almost half of a million dollars per treatment is not".

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