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Positive efficacy and safety for its promising CAR-T therapy sparked optimism that the company can secure an early FDA approval.
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After the company reported positive results from a mid-stage study evaluating its novel approach to tackling blood cancer, shares in Kite Pharma, Inc. (NASDAQ: KITE) surged 34.6% higher in February, according to S&P Global Market Intelligence.
Kite Pharma's lead product candidate is axicabtagene ciloleucel, a chimeric antigen receptor T-cell therapy (CAR-T) under development for the treatment of non-Hodgkin lymphoma.
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CAR-T is a complex approach that involves removing a patient's T-cells, reengineering them so that they can better find and destroy cancer cells, and then putting them back into the patient.
On Feb. 27, Kite Pharma reported that axicabtagene ciloleucel was effective in trials, and that adverse events associated with the therapy were manageable. Specifically, 41% of patients were still responding to the drug at the six-month mark, including 36% who were in complete response.
Although other CAR-T drug developers have stumbled in terms of safety, Kite Pharma reported that the percentage of cases of cytokine response syndrome (CRS) declined between the interim analysis and final analysis of its trial. The rate of neurologic events also declined, and there were no cases of brain swelling, something that previously had derailed Juno Therapeutics' lead CAR-T candidate last year.
Kite Pharma's management plans to finish axicabtagene ciloleucel's application for accelerated approval this month, and based on that timeline, a decision from the U.S. Food and Drug Administration could come as soon as this year.
Because these patients are no longer effectively treated by chemotherapy and they have limited other treatment options, this is a major advance. Kite Pharma has built enough production capacity to serve 4,000 patients in its first year. Given that most new cancer drugs are hitting the market with six-figure price tags, this drug could produce hundreds of millions of dollars in revenue for the company.