USA – FDA Approvals Roundup: Tecartus, Breztri Aerosphere, Wynzora

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).

New approvals
Tecartus okayed as first CAR-T therapy for MCL
Kite’s Tecartus (brexucabtagene autoleucel), a customized, one-time therapy derived from a patient’s genetically modified T cells, has received accelerated approval for treating adults with relapsed or refractory mantle cell lymphoma (MCL).
 
It is the first chimeric antigen receptor T-cell (CAR-T) therapy approved by the FDA for the treatment of MCL, a rare form of malignant B-cell non-Hodgkin lymphoma prevalent in older adults. The genetic modifications in the CAR-T therapy allow it to target and destroy the lymphoma cells after its infusion back into the patient.
 
“Tremendous progress has been made in the discovery of new therapies for debilitating diseases that are difficult to treat. This approval is yet another example of customized treatments that use a patient’s own immune system to help fight cancer,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research (CBER).
 
The drug’s safety and efficacy were established in ZUMA-2, a multicenter, single-arm, open-label clinical trial that enrolled 74 patients with previously treated refractory or relapsed MCL who received a single infusion of Tecartus. They were followed for at least 6 months after their first objective disease response. Of those patients, 87% had an objective response to the single infusion, and 62% achieved complete remission.
 
Tecartus has been approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use, because it has a boxed warning for cytokine release syndrome and neurologic toxicity. Its REMS measures are the same as those for Yescarta (axicabtagene ciloleucel, another CAR-T therapy from the Kite stable, approved for treating large B-cell lymphoma…