March 27, 2017
The FDA has given approval to Tesaro for the use of its PARP drug niraparib, which will now be marketed as Zejula as a maintenance therapy for the treatment of recurrent ovarian cancer.
Tesaro had argued that the efficacy data for niraparib qualified for an approval for use in patients who are either HRD positive or HRD negative. This approval also helps position Tesaro against AstraZeneca, which has recently delivered stellar Phase III data on its PARP Lynparza.
Mary Lynne Hedley, president and COO of TESARO, said: “With the approval of ZEJULA in hand, we will now begin to execute on our plans to pursue potentially transformational applications of niraparib in a broad range of metastatic cancer indications. We plan to expand our first-line ovarian cancer strategy to include a combination study that assesses the potential benefit of niraparib plus an anti-PD-1 antibody in the maintenance setting and initiate a clinical study of niraparib in combination with bevacizumab in patients with a first recurrence of ovarian cancer, with an intent to replace chemotherapy in this setting. We remain strongly committed to studying niraparib in the breast cancer setting and also expect to initiate a new trial of niraparib in combination with an anti-PD-1 antibody in women with metastatic triple-negative breast cancer. Finally, our goal to move niraparib into indications beyond ovarian and breast cancers encompasses plans to initiate a registration strategy for the first-line treatment of patients with metastatic non-small cell lung cancer that includes a phase 2 trial of niraparib in combination with an anti-PD-1 antibody in patients, regardless of PDL-1 tumor expression, and a phase 3 trial of niraparib in combination with an anti-PD-1 antibody in patients with high levels of PDL-1 tumor expression.”