FDA Approves Kite Pharma’s Cancer Drug Yescarta

Santa Monica-based Kite Pharma, a subsidiary of biopharma giant Gilead Sciences, announced on Friday that it has received approval from the Food and Drug Administration for a new immunotherapy drug that can be used in the early-stage treatment of certain cancers.

Yescarta, an intravenous CAR-T cell treatment that aims to bolster the immune system to fight cancer cells, is the first therapeutic of its kind to receive FDA approval for the early treatment of large B-cell lymphoma—a type of non-Hodgkin lymphoma—that has either relapsed or can’t be addressed with other cancer treatments like chemoimmunotherapy.

Most CAR-T cell therapies are reserved as a last resort for cancer patients who have exhausted all other options. At that point, however, their immune systems may be too weak to effectively utilize the therapeutic. While most clinical CAR-T cell trials involve patients who are at an advanced stage in their cancer treatments, Yescarta’s clinical trial was filled with patients who used the drug as a second- or third-resort.

CAR-T cell therapies have taken the oncology world by storm as a promising, potentially less invasive route for treating cancers, with many local biotech firms making moves in the space. In January, West Hills-based ImmPACT Bio raised $111 million to further its work of reengineering patients’ cells to boost the immune system. Culver City-based Appia Bio, meanwhile, emerged from stealth last spring to create off-the-shelf cell therapies that can be delivered quicker and cheaper to patients, and inked a deal with Kite Pharma last August to develop CAR-T cell treatments.

Kite Pharma has focused almost exclusively on CAR-T cell therapies since it was founded in 2009. Gilead Sciences acquired Kite for $11.9 billion in 2017.

“Kite started with a very bold goal: creating the hope of survival through cell therapy,” Kite CEO Christi Shaw said in a statement. “Today’s FDA approval brings that hope to more patients by enabling the power of CAR-T cell therapy to be used earlier in the treatment journey. This milestone has been years in the making.”