FDA expands talazoparib use in prostate cancer

The combination with enzalutamide reduced the risk of radiographic progression or death by 52% .

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The FDA approved talazoparib plus enzalutamide for adults with HRR-mutated metastatic androgen pathway modulation-naïve or -sensitive prostate cancer.
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Eligible patients must have an HRR gene mutation identified by an FDA-authorized test; FoundationOneCDx and FoundationOne Liquid CDx are approved companion diagnostics.
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In the 599-patient TALAPRO-3 trial, the combination reduced the risk of radiographic progression or death by 52% versus placebo plus enzalutamide (hazard ratio, 0.48).
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Median radiographic progression-free survival was not reached with talazoparib plus enzalutamide and was 45.8 months with placebo plus enzalutamide; overall survival data were immature.
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Grade 3 or higher anemia occurred in 51% of combination-treated patients versus 3% of controls, and blood counts should be monitored before treatment and monthly thereafter.

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