After gaining approval for Xospata to treat acute myeloid leukemia (AML) in 2018, Astellas has had difficulty expanding its label.
FDA Confirms Paragraph IV Patent Litigation for Gilteritinib Fumarate Tablets
SAN MATEO, Calif., Aug. 22, 2022 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced that the first patient has been dosed in a Phase 1b/2 clinical trial of lanraplenib in combination with gilteritinib in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia (AML).
Gilteritinib is approved for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML) with an FLT3-mutation (FLT3mut+). However, the gilteritinib phase 3 ADMIRAL study (Perl et al NEJM 2019) was conducted prior to widespread adoption of either midostaurin as a component of standard intensive induction and consolidation or posttransplant FLT3 inhibitor maintenance. We performed a retrospective analysis using data from 11 US centers and where we identified 113 patients who received gilteritinib alone or as combination therapy for the treatment of R/R FLT3mut+ AML. The composite complete remission (CR) rate (CRc, defined as CR?+?CRi?+?CR with incomplete platelet recovery [CRp]) was 48.7% (n = 55).
Astellas' Xospata won FDA approval in 2018 for patients who have the FLT3 mutation, and right now it's primarily used in the relapsed/refractory population. In the Lacewing study, Astellas wanted to see if the drug could be effective when paired with Bristol Myers Squibb’s chemo treatment Vidaza earlier in the treatment timeline.