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FDA Approves Brexucabtagene Autoleucel for Adults With Relapsed/Refractory MCL
On July 24, 2020, the FDA gave brexucabtagene autoleucel (Tecartus; Kite) accelerated approval for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL). This drug was granted orphan drug designation, breakthrough therapy designation, and priority review by the FDA for this indication.
This approval was based on data from the open-label, multi-center ZUMA-2 clinical trial of 74 patients with relapsed or refractory MCL previously given anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody, and a BTK inhibitor.
After completing lymphodepleting chemotherapy, patients in the study were given a single infusion of brexucabtagene autoleucel. The primary efficacy end point of ZUMA-2 was the objective response rate (ORR) per 2014 Lugano criteria as assessed by an independent review committee.
Overall, the ORR was 80% (95% CI, 69-88), with a CR rate of 55% (95% CI, 43-67).
Among 60 patients deemed evaluable for efficacy based on a minimum duration of follow-up (6 months), the ORR was 87% (95% CI, 75-94), with a complete remission (CR) rate of 62% (95% CI, 48-74).
As of a median follow-up of 8.6 months, the estimated median duration of response was not reached.
The most frequently reported (≥10%) grade ≥3 reactions with brexucabtagene autoleucel were anemia, neutropenia, thrombocytopenia, hypotension, hypophosphatemia, encephalopathy, leukopenia, hypoxia, pyrexia, hyponatremia, hypertension, infection (pathogen unspecified), pneumonia, hypocalcemia, and lymphopenia.—Alexis Hyams
Source: US Food and Drug Administration. FDA approves brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma. July 24, 2020. www.fda.gov/drugs/fda-approves-brexucabtagene-autoleucel-relapsed-or-refractory-mantle-cell-lymphoma. Accessed July 27, 2020.
