FDA News

FDA grants priority review to niraparib for gynecologic cancers

The FDA granted priority review to niraparib for the treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer following response to platinum-based chemotherapy, according to the drug’s manufacturer.

“FDA’s acceptance of the niraparib new drug application with a priority review designation is an important milestone for Tesaro, and represents a significant step in our efforts to bring meaningful therapies to women with ovarian cancer,” Mary Lynne Hedley, PhD, president and chief operation officer of TESARO, said in a press release. “We believe niraparib could become an important new treatment option for patients with recurrent ovarian cancer, and we look forward to working with the FDA during the review process.”

The ENGOT-OV16/NOVA trial — a double blind, placebo-controlled, international phase 3 study of niraparib (formerly MK-4827, Tesaro) in 533 patients — achieved its primary endpoint in both cohorts, which were based upon germline BRCA mutation status.

BRCA mutation carriers who underwent niraparib treatment demonstrated superior PFS compared with the control arm (21 months vs. 5.5 months; HR = 0.27; 95% CI, 0.17-0.41).

The non-germline BRCA mutant cohort who underwent treatment also had superior PFS (9.3 months vs. 3.9 months; HR = 0.45; 95% CI, 0.34-0.61).

Therefore, the proposed indication included the use of niraparib regardless of tumor biomarker status.

The BRACAnalysis CDx (Myriad Genetics) and myChoice HRD (Myriad Genetics) tests are anticipated to be available as complementary diagnostics, according to the release.

The most common grade 3 to grade 4 adverse events included thrombocytopenia (33.8%), anemia (25.3%) and neutropenia (19.6%).

An expanded access program for niraparib in the United States is planned to open in January 2017.

The FDA established a target action date of June 30, 2017 to make a decision regarding this application.

The FDA granted priority review to niraparib for the treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer following response to platinum-based chemotherapy, according to the drug’s manufacturer.

“FDA’s acceptance of the niraparib new drug application with a priority review designation is an important milestone for Tesaro, and represents a significant step in our efforts to bring meaningful therapies to women with ovarian cancer,” Mary Lynne Hedley, PhD, president and chief operation officer of TESARO, said in a press release. “We believe niraparib could become an important new treatment option for patients with recurrent ovarian cancer, and we look forward to working with the FDA during the review process.”

The ENGOT-OV16/NOVA trial — a double blind, placebo-controlled, international phase 3 study of niraparib (formerly MK-4827, Tesaro) in 533 patients — achieved its primary endpoint in both cohorts, which were based upon germline BRCA mutation status.

BRCA mutation carriers who underwent niraparib treatment demonstrated superior PFS compared with the control arm (21 months vs. 5.5 months; HR = 0.27; 95% CI, 0.17-0.41).

The non-germline BRCA mutant cohort who underwent treatment also had superior PFS (9.3 months vs. 3.9 months; HR = 0.45; 95% CI, 0.34-0.61).

Therefore, the proposed indication included the use of niraparib regardless of tumor biomarker status.

The BRACAnalysis CDx (Myriad Genetics) and myChoice HRD (Myriad Genetics) tests are anticipated to be available as complementary diagnostics, according to the release.

The most common grade 3 to grade 4 adverse events included thrombocytopenia (33.8%), anemia (25.3%) and neutropenia (19.6%).

An expanded access program for niraparib in the United States is planned to open in January 2017.

The FDA established a target action date of June 30, 2017 to make a decision regarding this application.