………… catching up on FDA approvals
The FDA recently approved a new infused therapy, Aucatzyl (obecabtagene autoleucel) from Autolus Inc., indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Aucatzyl is a CD19-directed genetically modified autologous T cell immunotherapy.
Acute lymphoblastic leukemia is a cancer in which B-cell lymphoblasts are found in the bone marrow and blood. ALL accounts for less than 1% of all cancers in the United States. The American Cancer Society estimates that in 2024 there will be about 6,550 new cases of ALL and about 1,330 deaths. Survival rates remain very poor in adult patients with r/r ALL, with median overall survival of eight months.
Aucatzyl was approved with a Black Box warning, however, the FDA did not impose a REMS program which is uncommon.
The company confirmed that the annual wholesale acquisition cost for Aucatzyl is $525,000. It is priced in the same general price bracket as two competing products, Kymriah and Tecartus.
The company did not announce details on its plans for distribution.
CLICK HERE to access prescribing information
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