ATHENA study evaluating Rubraca monotherapy versus placebo (ATHENA-MONO) successfully achieved the primary endpoint of improved PFS in both populations in the primary efficacy analyses: HRD-positive and all patients randomized (ITT)
Median PFS of 20.2 months for Rubraca vs 9.2 months for placebo in the ITT population
The exploratory PFS endpoints were also achieved in both HRD-negative and BRCA mutant subgroups of patients
Safety of Rubraca observed in ATHENA-MONO was consistent with both the current US and European labels
ATHENA-MONO results will serve as the basis of a supplemental NDA for US label expansion to be submitted during Q2 2022; European submission to follow during Q3 2022
These data, including additional analyses, have been submitted for presentation at the American Society of Clinical Oncology Annual Meeting in June 2022
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