The FDA approval is based on results from the Phase 3 ZUMA-7 study, evaluating the safety and efficacy of Yescarta compared to the current standard of care (SOC)
Yescarta granted US FDA approval to treat LBCL. (Credit: Julia Koblitz on Unsplash)
Kite Pharma, a biotechnology company of Gilead, has received the US Food and Drug Administration (FDA) approval for Yescarta (axicabtagene ciloleucel) to treat a type of large B-cell lymphoma (LBCL).
Yescarta is a CAR T-cell therapy indicated for adult patients with LBCL, refractory to first-line chemoimmunotherapy or that relapses within 12 months of chemoimmunotherapy.
The drug was previously granted FDA approval in 2017 to treat patients with LBCL who did not respond to two previous rounds of therapy, based on the ZUMA-1 trial.
Earlier this month, the National Comprehensive Cancer Network (NCCN) has amended its guidelines for the treatment of B-cell Lymphomas to include Yescarta.
Yescarta is the first CAR T-cell therapy to receive an NCCN Category 1 recommendation.
Kite chief executive officer Christi Shaw said: “Kite started with a very bold goal: creating the hope of survival through cell therapy. 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.”
The current FDA approval is based on results from the Phase 3 ZUMA-7 study, evaluating the safety and efficacy of Yescarta compared to the current standard of care (SOC).
The SOC includes a platinum-based salvage combination chemoimmunotherapy regimen followed by high-dose therapy and ASCT in those who respond to salvage chemotherapy.
In the study, Yescarta showed a clinically meaningful and statistically significant improvement in event-free survival over the current standard of care (SOC).
The drug has shown a safety profile that was consistent with previous studies.
Yescarta is also being reviewed by regulatory authorities worldwide, for additional indications inclusive of the ZUMA-7 patient population, said the company.
ZUMA-7 principal investigator Frederick L Locke said: “Today’s approval marks an exciting new standard of care. The ZUMA-7 trial enabled us to look at the broader picture of what happens to patients after a decision is made to follow a particular treatment path.
“What we found was that axi-cel resulted in three times as many patients receiving treatment with curative intent (CAR T-cell therapy), and an overall better outcome for patients than the previous standard of care.”