Article Figures & Data
Figures
- Figure 1.
NOVA study design.
- Figure 2.
A, Kaplain–Meier (K–M) curve of PFS per IRC assessment for the gBRCAm cohort. B, K–M curve of PFS per IRC assessment for the non-gBRCAm cohort.
Tables
- Table 1.
FDA risk–benefit assessment
Dimension Evidence and uncertainties Conclusions and reasons Analysis of condition Ovarian cancer is the fifth cause of cancer death in women and represents 5% of all cancer deaths.
In 2018, it is estimated that there will be 22,240 new cases of ovarian cancer and that 14,070 women will die in the United States.
Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancers are serious, life-threatening, and incurable.
Current treatment options Most patients with ovarian cancer receive primary debulking surgery followed by chemotherapy with platinum plus taxanes with or without bevacizumab. Response rates in the first-line setting are high, but most patients will develop a recurrence within 2 years and die within 3 to 4 years of diagnosis.
Prior to the current approval, bevacizumab was the only FDA-approved maintenance therapy for the treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Benefit Niraparib demonstrated statistically significant and clinically meaningful improvement in PFS over placebo in both the gBRCAm cohort (HR, 0.26; 95% CI, 0.17–0.41; P < 0.0001) and the non-gBRCAm cohort (HR, 0.45; 95% CI, 0.34–0.61; P < 0.0001).
Evidence of effectiveness was supported by a statistically significant and clinically meaningful PFS improvement.
Risk The most common adverse reactions (AR) experienced (≥20%) were thrombocytopenia, anemia, neutropenia, leukopenia, palpitations, nausea, constipation, vomiting, abdominal pain/distention, mucositis/stomatitis, diarrhea, fatigue/asthenia, decreased appetite, headache, insomnia, nasopharyngitis, dyspnea, rash, and hypertension. AML/MDS, bone marrow suppression, and cardiovascular effects are the AR described in the warnings and precautions section of labeling.
The observed PFS benefits outweigh the risks in this patient population, which represents an unmet medical need.
Risk management Niraparib is intended to be prescribed by oncologists who are well versed in the identification and management of the toxicities associated with niraparib.
Labeling details dose interruption, reduction, or discontinuation.
AML/MDS, bone marrow suppression, and cardiovascular effects are the AR being described in the warnings and precautions section of labeling.
Laboratory and vital sign monitoring are recommended before and during treatment.
The safe use of niraparib can be managed through accurate labeling and routine oncology care.
Volume 24, Issue 17
