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FDA Submission Completed for Niraparib in Ovarian Cancer

Jason M. Broderick @jasoncology
Published: Tuesday, Nov 01, 2016

Mary Lynne Hedley, PhD

Mary Lynne Hedley, PhD

A new drug application (NDA) to the FDA has been completed for niraparib as a maintenance treatment for women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer, according to the company developing the PARP1/2 inhibitor, Tesaro.

Patient demographics were well balanced between the arms for each cohort. In the germline BRCA group, the median age was 57 years and 65.9% had an ECOG performance status (PS) of 0. In the placebo group, the median age was 58 years and 73.8% of patients had an ECOG PS of 0. Overall, 48.6% and 53.8% of patients had received ≥3 prior therapies, in the niraparib and placebo arms, respectively.

Across both cohorts, the majority of patients had stage III cancer (68.8% to 74.1%). Approximately half of patients had achieved a complete response to prior platinum-based therapy and a quarter had received prior bevacizumab. In the non-BRCA-mutant arm, 33.8% and 32.8% of patients had received ≥3 prior therapies.
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