First CAR T-Cell Therapy Approved for Mantle Cell Lymphoma

The FDA has now granted accelerated approval to brexucabtagene autoleucel (TecartusTM, Kite Pharma, formerly known as KTE-X19) for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL). Brexucabtagene autoleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, is the first CAR T-cell therapy approved for this rare type of B-cell non-Hodgkin lymphoma. Efficacy was evaluated in the multicenter, open-label phase 2 ZUMA-2 trial (NCT02601313), which enrolled 7...
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Zanubrutinib Approved for Mantle Cell Lymphoma

The FDA has approved zanubrutinib (Brukinsa®, BeiGene) for patients with relapsed/refractory mantle cell lymphoma (MCL) who have received at least one previous therapy. The approval was based on two clinical trials. BGB-3111-206, a single-arm phase 2 trial, enrolled 86 patients with MCL whose disease progressed following at least one prior therapy. Patients received 160 mg of zanubrutinib orally twice daily until unacceptable toxicity or disease progression. The study's primary end point was ove...
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