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Novartis's CAR-T gene therapy for cancer gets FDA approval

Novartis International AG on Wednesday approved by US Food and Drug Administration for gene-modified leukemia immunotherapy. The US$475,000 treatment marks a new paradigm for some cancers. Treatment called Kymriah approved for patients aged up to 25 years who are unhelpful using previous treatment methods for B-cell acute lymphoblastic leukemia (ALL).

Tinuku Novartis's CAR-T gene therapy for cancer gets FDA approval

The Basel-based biotech giant also announced an agreement with U.S. Centers for Medicare and Medicaid Services where payment for therapy will be based on clinical outcomes. Analysts say the medical expenses are high, but everyone has a chance to save life.

Kymriah belongs to a new treatment class called CAR-T therapy that involves removal of T cells, modifying the genetic to better recognize and attack the cancer, then replace it when it circulates for years to search for this disease.

Shares of other biotech companies such as Gilead Sciences Inc., which this week announced a US$11.9 billion deal to buy Kite Pharma, rose 6.2 percent to US$80.47 late Wednesday. Kite Pharma is widely expected to receive subsequent approval for CAR-T therapy. Shares of Bluebird Bio Inc also gained 11.1 percent to US$113.73.

Clinical trials of CAR-T therapy have shown remarkable efficacy to fight blood cancer. The Novartis experiment showed 83 percent of patients achieved remission with a disease that had historically poor results.

However, this type of therapy carries the risk of severe side effects. Kymriah will have a warning for cytokine release syndrome, a potentially deadly systemic response to activation and proliferation of CAR-T cells, leading to high fever and potential neurological problems.


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