Last Updated: August 30, 2017.
Novartis AG on Wednesday won highly anticipated US approval for the first of a new type of potent gene-modifying immunotherapy for leukemia, a $475,000 treatment that marks the start of a potential new treatment paradigm for some cancers.
This first use of CAR-T therapy is aimed at patients desperately ill with acute lymphoblastic leukaemia, which strikes more than 3,000 children and young adults in the USA each year. Gilead shares jumped 5.5 percent on Wednesday as Kite is widely seen as likely to receive the next US approval of a CAR-T therapy.
"This is remarkable technology", said Dr. Mikkael Sekeres of the American Society of Hematology. Novartis also considered the cost of bone-marrow transplants, which are now given to many leukemia patients whose cancer relapses. We now have proof that it is possible to eradicate cancer by harnessing the power of a patient's own immune system. Patients may be at increased risk for infections for a prolonged period of time after infusion as the treatment may also destroy normal B cells.
About 3,100 patients 20 and younger are diagnosed with ALL each year, according to the U.S. National Cancer Institute.
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"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". Kymriah handles this turbocharging within the patients body.
This therapy, which is made using a patient's own immune cells, won't be cheap.
However, Anderson noted that "this approval only pertains to a small population of children".
The FDA approved Novartis' Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia. In a trial of Kymriah, 83 percent of 63 patients with hard-to-treat disease were in remission within three months, according to Novartis. An immune overreaction called "cytokine release syndrome" can trigger high fevers, plummeting blood pressure and in severe cases organ damage, requiring special care to tamp down those symptoms without blocking the cancer attack.
And then there's the issue of cost.
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"I don't want to be an apologist for high drug prices in the U.S.", Grupp stressed. In New York, even budget hotels cost more than $200 a night an expense not typically covered by insurance.
Other genetic therapies for cancer are also in the research pipeline.
The drug has shown promising remission and survival rates in clinical trials, the FDA said.
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.
"The theory is they should attack the tumor and continue to grow to become a long-term monitoring and treatment system", Lichtenfeld said.
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