Kite secures FDA approval for second CAR T therapy Tecartus in relapsed or refractory mantle cell lymphoma
pharmafile | July 27, 2020 | News story | Sales and Marketing | CAR T, CAR-T, FDA, Gilead, kite pharma
Kite Pharma has chalked up another regulatory success for its parent company Gilead with the news that the FDA has awarded approval to Tecartus (brexucabtagene autoleucel), the company’s second approved chimeric antigen receptor (CAR) T cell therapy after Yescarta, and the first authorised for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), a rare form of non-Hodgkin lymphoma.
The decision comes on the heels of a priority review and Breakthrough Therapy Designation awarded to the therapy, and was based on trial data which showed that Tecartus demonstrated a clinical response in 87% of 74 adult participants, with 62% achieving a complete response.
“Despite promising advances, there are still major gaps in treatment for patients with MCL who progress following initial therapy,” explained Dr Michael Wang, lead Investigator on the study and a Professor in the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center’s Division of Cancer Medicine. “Many patients have high-risk disease and are more likely to keep progressing, even after subsequent treatments. The availability of Tecartus as the first-ever cell therapy for patients with relapsed/refractory MCL provides an important option with a response rate of nearly 90% and early clinical evidence suggesting durable remissions in later lines of therapy.”
In trials, Kite was able to manufacture the drug with a success rate of 96% with a median turnaround of 15 days from leukapheresis to product delivery. Kite confirmed that the therapy will be manufactured at its manufacturing facility in El Segundo, California.
Matt Fellows
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