FDA grants talazoparib priority review for BRCA+ breast cancer

2018-07-01

In the phase III randomized EMBRACA trial (NCT01945775), talazoparib showed a significant PFS benefit compared to physician’s choice of therapy (capecitabine, eribulin, gemcitabine, or vinorelbine). The median PFS was 8.6 months (95% CI, 7.2-9.3) with talazoparib (n=287) compared to 5.6 months (95% CI, 4.2-6.7) with physician’s choice of therapy (n=144) (HR, 0.54; 95% CI, 0.41-0.71; p < 0.0001). The ORR was 62.6% (n=219) (95% CI, 55.8-69.0) versus 27.2% (n=114) (95% CI, 19.3-36.3), respectively (odds ratio, 4.99; 95% CI, 2.9-8.8; p < 0.0001). These results provide a significant option for patients with BRCA mutations and metastatic breast cancer.

http://cancerres.aacrjournals.org/content/78/4_Supplement/GS6-07