Gilead's Yescarta Scores FDA Approval As First CAR T-Cell Therapy For Earlier Lymphoma

The FDA approved the expanded use of Gilead Sciences Inc's GILD Yescarta, a cell therapy made by the Kite Pharma unit.
The approval covers Yescarta (axicabtagene ciloleucel) for adult patients with large B-cell lymphoma refractory to first-line chemoimmunotherapy or relapsing within 12 months of first-line chemoimmunotherapy.
Related: Gilead's CAR-T Yescarta Shows 78% Complete Response Rate In First-Line Lymphoma Patients.
The one-time treatment was initially approved in 2017 for patients with large B-cell lymphoma who did not respond to at least two previous rounds of therapy.
The National Comprehensive Cancer Network has already listed Yescarta in the first category of treatments for those patients.
The FDA said the drug's label warns of a serious complication associated with cytokine release syndrome and neurologic toxicities.
Yescarta demonstrated a clinically meaningful and statistically significant improvement in event-free survival (EFS) over the current standard of care (SOC).
Additionally, 2.5 times more patients receiving Yescarta (40.5%) were alive at two years without disease progression or needed additional cancer treatment after a one-time infusion of Yescarta vs. SOC (16.3%).
The median EFS was four-fold greater (8.3 months vs. 2.0 months) with Yescarta vs. SOC.
Price Action: GILD shares closed 0.37% higher at $59.67 on Friday.