It’s the third approval for a specific use for a Kite Pharma cell therapy.
Kite was founded as an independent biopharmaceutical company in 2009 by noted oncologist Arie Belldegrun. It was acquired by Foster City-based pharma giant Gilead Sciences Inc. in 2017 for $11.9 billion.
Since the sale, Kite has operated as a subsidiary of Gilead. Belldegrun and several of Kite’s top scientists left the company to found Allogene Therapeutics, based in South San Francisco.
Early on, Kite Pharma began developing an immunotherapy drug called Yescarta to treat various forms of cancer. The drug consists of a patient’s own immune system cells, called T-cells, which are genetically modified to attack cancer cells. This process is known as chimeric antigen receptor, or CAR, T-cell therapy.
Yescarta was initially designed for patients who have already undergone treatment for acute lymphoblastic leukemias that start in white blood cells. Patients eligible to use Yescarta either still have cancer cells or have gone into remission but experience a relapse.
The FDA granted Yescarta a “breakthrough therapy designation” in late 2015 and approved it for use in 2017. Since then, Kite has sought to expand Yescarta’s application to other cancers.
The application that just received the FDA’s accelerated approval is for indolent follicular lymphoma, a form of non-Hodgkin lymphoma in which malignant tumors slowly grow but can become more aggressive over time. It is the second most common type of lymphoma, accounting for about 22% of all lymphomas diagnosed worldwide, according to the Kite announcement.
Currently, there are limited options for the treatment of this particular lymphoma after two or more types of therapy had already been applied. The five-year survival rate for patients in this situation is about 20%, Caron Jacobson, medical director of the Immune Effector Cell Therapy Program at the Dana-Farber Cancer Institute in Boston, said in the announcement.
The approval was granted after Kite presented clinical trial data showing 91% of patients with relapsed or refractory follicular lymphoma showed improvement after taking the drug; roughly 74% of patients experienced remission of the lymphoma for 18 months.
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