Cancer-killing drug approved, but will you be able to afford it?
01 September 2017, 01:34 | Robert Harris
Novartis' CAR-T gene therapy, the first approved by FDA, to be priced based on cancer patients' outcomes
Truly today's approval of the gene therapy by FDA is a milestone in the treatment of leukemia and it is expected that treatment becomes successful on long term basis.
The new treatment modifies patients' own immune T cells, which are collected and reprogrammed at the Novartis manufacturing facility to potentially seek and destroy the patients' leukemia cells.
The new treatment is the first USA approval of a treatment for genetic modification, and its maker promises some unprecedented pricing options- including offering it for free if it doesn't work quickly.
Gene therapy has been heralded as a powerful new weapon in the fight against cancer with some experts even claiming that eventually it could signal the end of the disease.
While 95 percent or more of children newly diagnosed with ALL can reach remission with standard therapy, between 10 and 15 percent of those children ultimately relapse within five years of being diagnosed.
The approval of Novartis' CAR-T therapy comes just two days after Gilead Sciences Inc. announced an agreement to spend $11.9 billion and buy Kite Pharma Inc., which is developing its own CAR-T therapy scheduled for an FDA ruling by November 29.
Doctors remove T cells from each cancer victim and ship the material to its factory in Morris Plains, New Jersey.
FDA Approves CAR T-Cell Therapy for Leukemia
The high cost of the therapy reflects the fact that the CAR-T procedure is fairly intensive. "The lessons learned from the clinical trials of vehicle T-cell operations will assist us in being able to provide to the larger population".
"The FDA is requiring that hospitals and their associated clinics that dispense Kymriah be specially certified", it added. Based on those results, an FDA advisory panel recommended the approval in July.
Shares of Juno Therapeutics Inc, which a year ago reported a handful of patient deaths during trials of its CAR-T therapy, were down 8.9 percent at $39.92.
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.
The price of the therapy is tagged at around $500,000.
Kymriah will carry a boxed warning because of the treatment's potential to cause deadly side effects, including neurological complications and what's known as cytokine release syndrome, a systemic reaction triggered by the destruction of the cancer cells.
Questions also remain about the drug's possible long-term side effects and ability to prevent ALL from coming back. The treatment costs $475,000. "While payers are developing their coverage policies for [tisagenlecleucel], we will offer an access program in the United States for eligible uninsured or underinsured patients". "The established path to commercialization taken by Novartis will provide considerable motivation for cell therapy scientists and development companies as well as investors looking to benefit from the ongoing success in the industry".
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