Existing CAR-T therapies have been saved for blood cancer patients who’ve tried multiple treatments—until now.
With a first-in-class nod, the FDA has cleared Yescarta, a CD19-directed CAR-T therapy made by Gilead Sciences’ Kite Pharma, for treating patients with large B-cell lymphoma that is refractory to one prior therapy or that relpases within 12 months of first-line chemoimmunotherapy.
Friday’s approval puts Yescarta ahead of Bristol Myers Squibb’s rival drug Breyanzi, which expects an FDA decision for the same second-line lymphoma indication by June 24.
Kite Pharma CEO Christi Shaw has put the eligible U.S. patient population for Yescarta in the second-line setting at 14,000 compared with 8,000 patients for its original third-line use. The new indication could get Yescarta $1.5 billion in peak sales over time, according to analysts at RBC Capital Markets.
The optimism—and the FDA nod—came from the phase 3 Zuma-7 trial. The study showed Yescarta reduced the risk of disease progression, death or the need for a new therapy by 60.2% compared to standard of care, which involves chemotherapy and stem cell transplant. At two years, 40.5% of Yescarta takers were still alive and didn’t require additional cancer treatment or experience cancer progression, versus 16.3% for the control arm.
It’s also worth noting that, while 94% of patients in the Yescarta group successfully received the CAR-T therapy, only 36% of those in the control arm actually made it to stem cell transplant, Shaw noted during an interview.