The company also indicated that data from the mid-stage trial was strong enough to file for marketing approval with the FDA. If the FDA gives the green light, then Kite will have the distinction of the first to get approval of a CAR-T therapy.
CAR-T therapy is an approach in immunotherapy, which harnesses the power of a patient's immune system to combat the disease, and is now called the fifth pillar of cancer treatment. CAR-T, or chimeric antigen receptors are proteins that allow the T-cells to recognize a specific protein or antigen on tumor cells.
Novartis AG (ADR) NVS and Juno Therapeutics Inc JUNO are also working for a breakthrough in the novel treatment methodology.
Juno, which is developing a CAR-T therapy for lymphoblastic leukemia, was forced to modify its trial following halting of the trial in June in the wake of deaths of several trial participants. The company reasoned that the deaths were due to neurotoxicity resulting from chemo agent fludarabine used in the CAR-T pre-conditioning regimen. Consequently, the company was forced to push back the target launch date to the first half of 2018 from 2017.
However, Juno's therapy candidate was found to be very effective in an early stage trial and the company is all set to go ahead with the mid-stage trial.
Analysts see a $10 billion annual sales opportunity for the CAR-T therapies.
In pre-market, trading Juno Therapeutics was up 6.61 percent at $31.61 and Kite Pharma was up 9.89 percent at $60.42. Novartis ADS was down 1.15 percent at $79.80.
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