Feds Give Kite Pharma's Pricy Cancer Treatment the Green Light

Frederick Owens
October 20, 2017

Yescarta is approved for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of conventional therapy.

The therapy is called Yescarta - the generic name is axicabtagene ciloleucel. The therapy is not indicated for the treatment of patients with primary central nervous system lymphoma. "This approval would not have been possible without the courageous commitment of patients and clinicians, as well as the ongoing dedication of Kite's employees", Kite founder Dr. Arie Belldegrun said. "Together, Gilead and Kite will accelerate studies of auto T therapy in multiple blood cancers and advance other cell therapy approaches for solid tumors, with the goal of helping patients with diverse cancers benefit from this new era of personalized cancer therapy". "We believe this is only the beginning for auto T therapies". Gilead and Kite are accelerating studies of CAR-T therapy in multiple blood cancers.

But Yescarta is not without risk, and the FDA said it will carry a warning for neurologic toxicities and cytokine release syndrome, a condition in which the body reacts to the CAR-T cells with high fever and other flu-like symptoms.

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Because of these risks, the FDA has approved Yescarta with a risk evaluation and mitigation strategy (REMS), which includes a requirement that hospitals and clinics be specially certified before dispensing the therapy. It is now working to train another 30 centers, with a goal of opening 70 to 90 Yescarta centers across the nation. The most common one accounts for about a third of the estimated 72,000 new cases of non-Hodgkin lymphoma diagnosed each year. Historically, when treated with the current standard of care, patients with refractory large B-cell lymphoma had a median overall survival of approximately six months, with only 7% attaining a complete response. Because of the combination of this process and the innovativeness of the product there were fears until the last minute that the FDA would get cold feet and not approve it, but in the end, thanks to convincing clinical information and the because of the lack of an alternative for the kind of cancer that the product treats, it was approved. That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies. "Now, thanks to this new therapy many patients are in remission for months".

Currently, up to half of all patients with large B-cell lymphoma relapse or become resistant to treatments, which may include chemotherapy, stem cell transplants, and immunotherapy. Gilead states that the T cells can be produced within 17 days with 99% success.

"Engineered cell therapies like Yescarta represent the potential for a changing treatment paradigm for cancer patients", David Chang, MD, PhD, Worldwide Head of Research and Development and Chief Medical Officer at Kite, said in a statement. Returned to the patient, all the revved-up cells can continue multiplying to fight disease for months or years. Other side effects include infections, low blood cell counts, and dampened immune system.

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