FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Zejula (niraparib)

Indication:

Maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who are in a complete or partial response to platinum-based chemotherapy.

Mechanism:

Inhibitor of poly (ADP-ribose) polymerase (PARP), which results in DNA damage, apoptosis, and cell death. Unlike other PARP inhibitors (eg, olaparib, rucaparib), it is active both in patients with and in those without BRCA mutations.

Dosage:

300 mg PO once daily. Continue until disease progression or unacceptable toxicity.

Approval:

Approval was based on results from the NOVA phase 3 trial (n=553). The niraparib group had a significantly longer median duration of progression-free survival (PFS) than did those in the placebo group, including 21.0 vs. 5.5 months in the germline BRCA mutation (gBRCA) cohort; 12.9 months vs. 3.8 months in the non-gBRCA cohort for patients who had tumors with homologous recombination deficiency (HRD); and 9.3 months vs. 3.9 months in the overall non-gBRCA cohort (P<0.001 for all 3 comparisons).

Reference:

Mirza MR, Monk BJ, Herrstedt J, et al. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016; 375:2154-64.

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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.