Autolus Therapeutics’ Aucatzyl is now FDA approved for treating advanced cases of B-cell precursor acute lymphoblastic leukemia. While it goes after the same target as Gilead Sciences’ Tecartus, Autolus engineered its CAR T-therapy with properties that could improve safety, efficacy, and durability.
Still, despite costs largely in line with the therapy's benefits, the study's author and another expert said reimbursement models have not kept up and need improvement.
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In a first, the agency approved Adaptive Biotechnologies' clonoSEQ assay to detect MRD in acute lymphoblastic leukemia and multiple myeloma, a measure that can predict risk of relapse.
The decision is not final, but the Swiss drugmaker's shares were down 1 percent in morning trading. NICE reached a similar decision last month on competitor Gilead's Yescarta.