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CCR Drug Updates

FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy

Gwynn Ison, Lynn J. Howie, Laleh Amiri-Kordestani, Lijun Zhang, Shenghui Tang, Rajeshwari Sridhara, Vadryn Pierre, Rosane Charlab, Anuradha Ramamoorthy, Pengfei Song, Fang Li, Jingyu Yu, Wimolnut Manheng, Todd R. Palmby, Soma Ghosh, Hisani N. Horne, Eunice Y. Lee, Reena Philip, Kaushalkumar Dave, Xiao Hong Chen, Sharon L. Kelly, Kumar G. Janoria, Anamitro Banerjee, Okponanabofa Eradiri, Jeannette Dinin, Kirsten B. Goldberg, William F. Pierce, Amna Ibrahim, Paul G. Kluetz, Gideon M. Blumenthal, Julia A. Beaver and Richard Pazdur
Gwynn Ison
Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
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  • For correspondence: Gwynn.Ison@fda.hhs.gov
Lynn J. Howie
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Laleh Amiri-Kordestani
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Lijun Zhang
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Shenghui Tang
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Rajeshwari Sridhara
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Vadryn Pierre
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Rosane Charlab
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Anuradha Ramamoorthy
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Pengfei Song
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Fang Li
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Jingyu Yu
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Wimolnut Manheng
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Todd R. Palmby
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Soma Ghosh
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Hisani N. Horne
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Eunice Y. Lee
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Reena Philip
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Kaushalkumar Dave
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Xiao Hong Chen
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Sharon L. Kelly
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Kumar G. Janoria
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Anamitro Banerjee
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Okponanabofa Eradiri
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Jeannette Dinin
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Kirsten B. Goldberg
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William F. Pierce
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Amna Ibrahim
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Paul G. Kluetz
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Gideon M. Blumenthal
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Julia A. Beaver
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Richard Pazdur
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DOI: 10.1158/1078-0432.CCR-18-0042 Published September 2018
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    Figure 1.

    NOVA study design.

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    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.

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    FDA risk–benefit assessment

    DimensionEvidence and uncertaintiesConclusions 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.

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Clinical Cancer Research: 24 (17)
September 2018
Volume 24, Issue 17
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FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy
Gwynn Ison, Lynn J. Howie, Laleh Amiri-Kordestani, Lijun Zhang, Shenghui Tang, Rajeshwari Sridhara, Vadryn Pierre, Rosane Charlab, Anuradha Ramamoorthy, Pengfei Song, Fang Li, Jingyu Yu, Wimolnut Manheng, Todd R. Palmby, Soma Ghosh, Hisani N. Horne, Eunice Y. Lee, Reena Philip, Kaushalkumar Dave, Xiao Hong Chen, Sharon L. Kelly, Kumar G. Janoria, Anamitro Banerjee, Okponanabofa Eradiri, Jeannette Dinin, Kirsten B. Goldberg, William F. Pierce, Amna Ibrahim, Paul G. Kluetz, Gideon M. Blumenthal, Julia A. Beaver and Richard Pazdur
Clin Cancer Res September 1 2018 (24) (17) 4066-4071; DOI: 10.1158/1078-0432.CCR-18-0042

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FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy
Gwynn Ison, Lynn J. Howie, Laleh Amiri-Kordestani, Lijun Zhang, Shenghui Tang, Rajeshwari Sridhara, Vadryn Pierre, Rosane Charlab, Anuradha Ramamoorthy, Pengfei Song, Fang Li, Jingyu Yu, Wimolnut Manheng, Todd R. Palmby, Soma Ghosh, Hisani N. Horne, Eunice Y. Lee, Reena Philip, Kaushalkumar Dave, Xiao Hong Chen, Sharon L. Kelly, Kumar G. Janoria, Anamitro Banerjee, Okponanabofa Eradiri, Jeannette Dinin, Kirsten B. Goldberg, William F. Pierce, Amna Ibrahim, Paul G. Kluetz, Gideon M. Blumenthal, Julia A. Beaver and Richard Pazdur
Clin Cancer Res September 1 2018 (24) (17) 4066-4071; DOI: 10.1158/1078-0432.CCR-18-0042
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