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

Publication Date:
2018-09-05
Publisher:
The American Association for Cancer Research (AACR)
Print ISSN:
1078-0432
Electronic ISSN:
1557-3265
Topics:
Medicine
Published by:
http://www.aacr.org/
_version_ 1836399042783870976
autor Ison, G., Howie, L. J., Amiri-Kordestani, L., Zhang, L., Tang, S., Sridhara, R., Pierre, V., Charlab, R., Ramamoorthy, A., Song, P., Li, F., Yu, J., Manheng, W., Palmby, T. R., Ghosh, S., Horne, H. N., Lee, E. Y., Philip, R., Dave, K., Chen, X. H., Kelly, S. L., Janoria, K. G., Banerjee, A., Eradiri, O., Dinin, J., Goldberg, K. B., Pierce, W. F., Ibrahim, A., Kluetz, P. G., Blumenthal, G. M., Beaver, J. A., Pazdur, R.
beschreibung The FDA approved niraparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, on March 27, 2017, for maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based chemotherapy. Approval was based on data from the NOVA trial comparing niraparib with placebo in two independent cohorts, based on germline BRCA mutation status (g BRCA m vs. non-g BRCA m). Progression-free survival (PFS) in each cohort was the primary endpoint. In the g BRCA m cohort, estimated median PFS on niraparib was 21 months versus 5.5 months on placebo [HR, 0.26; 95% confidence interval (CI), 0.17–0.41; P 〈 0.0001]. In the non-g BRCA m cohort, estimated median PFS for niraparib and placebo was 9.3 and 3.9 months, respectively (HR, 0.45; 95% CI, 0.34–0.61; P 〈 0.0001). Common adverse reactions (〉20% and higher incidence in the niraparib arm) with niraparib included thrombocytopenia, anemia, neutropenia, nausea, constipation, vomiting, mucositis, fatigue, decreased appetite, headache, insomnia, nasopharyngitis, dyspnea, rash, and hypertension. There were five cases of myelodysplastic syndrome and acute myeloid leukemia (1.4%) in patients treated with niraparib compared with two cases (1.1%) on placebo. Niraparib is the first PARP inhibitor approved as maintenance therapy for patients with ovarian, fallopian tube, or primary peritoneal cancer, with improvement in PFS, regardless of g BRCA m status. Clin Cancer Res; 24(17); 4066–71. ©2018 AACR . See related commentary by Konstantinopoulos and Matulonis, p. 4062
citation_standardnr 6327872
datenlieferant ipn_articles
feed_id 9363
feed_publisher The American Association for Cancer Research (AACR)
feed_publisher_url http://www.aacr.org/
insertion_date 2018-09-05
journaleissn 1557-3265
journalissn 1078-0432
publikationsjahr_anzeige 2018
publikationsjahr_facette 2018
publikationsjahr_intervall 7984:2015-2019
publikationsjahr_sort 2018
publisher The American Association for Cancer Research (AACR)
quelle Clinical Cancer Research
relation http://clincancerres.aacrjournals.org/cgi/content/short/24/17/4066?rss=1
search_space articles
shingle_author_1 Ison, G., Howie, L. J., Amiri-Kordestani, L., Zhang, L., Tang, S., Sridhara, R., Pierre, V., Charlab, R., Ramamoorthy, A., Song, P., Li, F., Yu, J., Manheng, W., Palmby, T. R., Ghosh, S., Horne, H. N., Lee, E. Y., Philip, R., Dave, K., Chen, X. H., Kelly, S. L., Janoria, K. G., Banerjee, A., Eradiri, O., Dinin, J., Goldberg, K. B., Pierce, W. F., Ibrahim, A., Kluetz, P. G., Blumenthal, G. M., Beaver, J. A., Pazdur, R.
shingle_author_2 Ison, G., Howie, L. J., Amiri-Kordestani, L., Zhang, L., Tang, S., Sridhara, R., Pierre, V., Charlab, R., Ramamoorthy, A., Song, P., Li, F., Yu, J., Manheng, W., Palmby, T. R., Ghosh, S., Horne, H. N., Lee, E. Y., Philip, R., Dave, K., Chen, X. H., Kelly, S. L., Janoria, K. G., Banerjee, A., Eradiri, O., Dinin, J., Goldberg, K. B., Pierce, W. F., Ibrahim, A., Kluetz, P. G., Blumenthal, G. M., Beaver, J. A., Pazdur, R.
shingle_author_3 Ison, G., Howie, L. J., Amiri-Kordestani, L., Zhang, L., Tang, S., Sridhara, R., Pierre, V., Charlab, R., Ramamoorthy, A., Song, P., Li, F., Yu, J., Manheng, W., Palmby, T. R., Ghosh, S., Horne, H. N., Lee, E. Y., Philip, R., Dave, K., Chen, X. H., Kelly, S. L., Janoria, K. G., Banerjee, A., Eradiri, O., Dinin, J., Goldberg, K. B., Pierce, W. F., Ibrahim, A., Kluetz, P. G., Blumenthal, G. M., Beaver, J. A., Pazdur, R.
shingle_author_4 Ison, G., Howie, L. J., Amiri-Kordestani, L., Zhang, L., Tang, S., Sridhara, R., Pierre, V., Charlab, R., Ramamoorthy, A., Song, P., Li, F., Yu, J., Manheng, W., Palmby, T. R., Ghosh, S., Horne, H. N., Lee, E. Y., Philip, R., Dave, K., Chen, X. H., Kelly, S. L., Janoria, K. G., Banerjee, A., Eradiri, O., Dinin, J., Goldberg, K. B., Pierce, W. F., Ibrahim, A., Kluetz, P. G., Blumenthal, G. M., Beaver, J. A., Pazdur, R.
shingle_catch_all_1 FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy
The FDA approved niraparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, on March 27, 2017, for maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based chemotherapy. Approval was based on data from the NOVA trial comparing niraparib with placebo in two independent cohorts, based on germline BRCA mutation status (g BRCA m vs. non-g BRCA m). Progression-free survival (PFS) in each cohort was the primary endpoint. In the g BRCA m cohort, estimated median PFS on niraparib was 21 months versus 5.5 months on placebo [HR, 0.26; 95% confidence interval (CI), 0.17–0.41; P < 0.0001]. In the non-g BRCA m cohort, estimated median PFS for niraparib and placebo was 9.3 and 3.9 months, respectively (HR, 0.45; 95% CI, 0.34–0.61; P < 0.0001). Common adverse reactions (>20% and higher incidence in the niraparib arm) with niraparib included thrombocytopenia, anemia, neutropenia, nausea, constipation, vomiting, mucositis, fatigue, decreased appetite, headache, insomnia, nasopharyngitis, dyspnea, rash, and hypertension. There were five cases of myelodysplastic syndrome and acute myeloid leukemia (1.4%) in patients treated with niraparib compared with two cases (1.1%) on placebo. Niraparib is the first PARP inhibitor approved as maintenance therapy for patients with ovarian, fallopian tube, or primary peritoneal cancer, with improvement in PFS, regardless of g BRCA m status. Clin Cancer Res; 24(17); 4066–71. ©2018 AACR . See related commentary by Konstantinopoulos and Matulonis, p. 4062
Ison, G., Howie, L. J., Amiri-Kordestani, L., Zhang, L., Tang, S., Sridhara, R., Pierre, V., Charlab, R., Ramamoorthy, A., Song, P., Li, F., Yu, J., Manheng, W., Palmby, T. R., Ghosh, S., Horne, H. N., Lee, E. Y., Philip, R., Dave, K., Chen, X. H., Kelly, S. L., Janoria, K. G., Banerjee, A., Eradiri, O., Dinin, J., Goldberg, K. B., Pierce, W. F., Ibrahim, A., Kluetz, P. G., Blumenthal, G. M., Beaver, J. A., Pazdur, R.
The American Association for Cancer Research (AACR)
1078-0432
10780432
1557-3265
15573265
shingle_catch_all_2 FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy
The FDA approved niraparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, on March 27, 2017, for maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based chemotherapy. Approval was based on data from the NOVA trial comparing niraparib with placebo in two independent cohorts, based on germline BRCA mutation status (g BRCA m vs. non-g BRCA m). Progression-free survival (PFS) in each cohort was the primary endpoint. In the g BRCA m cohort, estimated median PFS on niraparib was 21 months versus 5.5 months on placebo [HR, 0.26; 95% confidence interval (CI), 0.17–0.41; P < 0.0001]. In the non-g BRCA m cohort, estimated median PFS for niraparib and placebo was 9.3 and 3.9 months, respectively (HR, 0.45; 95% CI, 0.34–0.61; P < 0.0001). Common adverse reactions (>20% and higher incidence in the niraparib arm) with niraparib included thrombocytopenia, anemia, neutropenia, nausea, constipation, vomiting, mucositis, fatigue, decreased appetite, headache, insomnia, nasopharyngitis, dyspnea, rash, and hypertension. There were five cases of myelodysplastic syndrome and acute myeloid leukemia (1.4%) in patients treated with niraparib compared with two cases (1.1%) on placebo. Niraparib is the first PARP inhibitor approved as maintenance therapy for patients with ovarian, fallopian tube, or primary peritoneal cancer, with improvement in PFS, regardless of g BRCA m status. Clin Cancer Res; 24(17); 4066–71. ©2018 AACR . See related commentary by Konstantinopoulos and Matulonis, p. 4062
Ison, G., Howie, L. J., Amiri-Kordestani, L., Zhang, L., Tang, S., Sridhara, R., Pierre, V., Charlab, R., Ramamoorthy, A., Song, P., Li, F., Yu, J., Manheng, W., Palmby, T. R., Ghosh, S., Horne, H. N., Lee, E. Y., Philip, R., Dave, K., Chen, X. H., Kelly, S. L., Janoria, K. G., Banerjee, A., Eradiri, O., Dinin, J., Goldberg, K. B., Pierce, W. F., Ibrahim, A., Kluetz, P. G., Blumenthal, G. M., Beaver, J. A., Pazdur, R.
The American Association for Cancer Research (AACR)
1078-0432
10780432
1557-3265
15573265
shingle_catch_all_3 FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy
The FDA approved niraparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, on March 27, 2017, for maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based chemotherapy. Approval was based on data from the NOVA trial comparing niraparib with placebo in two independent cohorts, based on germline BRCA mutation status (g BRCA m vs. non-g BRCA m). Progression-free survival (PFS) in each cohort was the primary endpoint. In the g BRCA m cohort, estimated median PFS on niraparib was 21 months versus 5.5 months on placebo [HR, 0.26; 95% confidence interval (CI), 0.17–0.41; P < 0.0001]. In the non-g BRCA m cohort, estimated median PFS for niraparib and placebo was 9.3 and 3.9 months, respectively (HR, 0.45; 95% CI, 0.34–0.61; P < 0.0001). Common adverse reactions (>20% and higher incidence in the niraparib arm) with niraparib included thrombocytopenia, anemia, neutropenia, nausea, constipation, vomiting, mucositis, fatigue, decreased appetite, headache, insomnia, nasopharyngitis, dyspnea, rash, and hypertension. There were five cases of myelodysplastic syndrome and acute myeloid leukemia (1.4%) in patients treated with niraparib compared with two cases (1.1%) on placebo. Niraparib is the first PARP inhibitor approved as maintenance therapy for patients with ovarian, fallopian tube, or primary peritoneal cancer, with improvement in PFS, regardless of g BRCA m status. Clin Cancer Res; 24(17); 4066–71. ©2018 AACR . See related commentary by Konstantinopoulos and Matulonis, p. 4062
Ison, G., Howie, L. J., Amiri-Kordestani, L., Zhang, L., Tang, S., Sridhara, R., Pierre, V., Charlab, R., Ramamoorthy, A., Song, P., Li, F., Yu, J., Manheng, W., Palmby, T. R., Ghosh, S., Horne, H. N., Lee, E. Y., Philip, R., Dave, K., Chen, X. H., Kelly, S. L., Janoria, K. G., Banerjee, A., Eradiri, O., Dinin, J., Goldberg, K. B., Pierce, W. F., Ibrahim, A., Kluetz, P. G., Blumenthal, G. M., Beaver, J. A., Pazdur, R.
The American Association for Cancer Research (AACR)
1078-0432
10780432
1557-3265
15573265
shingle_catch_all_4 FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy
The FDA approved niraparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, on March 27, 2017, for maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based chemotherapy. Approval was based on data from the NOVA trial comparing niraparib with placebo in two independent cohorts, based on germline BRCA mutation status (g BRCA m vs. non-g BRCA m). Progression-free survival (PFS) in each cohort was the primary endpoint. In the g BRCA m cohort, estimated median PFS on niraparib was 21 months versus 5.5 months on placebo [HR, 0.26; 95% confidence interval (CI), 0.17–0.41; P < 0.0001]. In the non-g BRCA m cohort, estimated median PFS for niraparib and placebo was 9.3 and 3.9 months, respectively (HR, 0.45; 95% CI, 0.34–0.61; P < 0.0001). Common adverse reactions (>20% and higher incidence in the niraparib arm) with niraparib included thrombocytopenia, anemia, neutropenia, nausea, constipation, vomiting, mucositis, fatigue, decreased appetite, headache, insomnia, nasopharyngitis, dyspnea, rash, and hypertension. There were five cases of myelodysplastic syndrome and acute myeloid leukemia (1.4%) in patients treated with niraparib compared with two cases (1.1%) on placebo. Niraparib is the first PARP inhibitor approved as maintenance therapy for patients with ovarian, fallopian tube, or primary peritoneal cancer, with improvement in PFS, regardless of g BRCA m status. Clin Cancer Res; 24(17); 4066–71. ©2018 AACR . See related commentary by Konstantinopoulos and Matulonis, p. 4062
Ison, G., Howie, L. J., Amiri-Kordestani, L., Zhang, L., Tang, S., Sridhara, R., Pierre, V., Charlab, R., Ramamoorthy, A., Song, P., Li, F., Yu, J., Manheng, W., Palmby, T. R., Ghosh, S., Horne, H. N., Lee, E. Y., Philip, R., Dave, K., Chen, X. H., Kelly, S. L., Janoria, K. G., Banerjee, A., Eradiri, O., Dinin, J., Goldberg, K. B., Pierce, W. F., Ibrahim, A., Kluetz, P. G., Blumenthal, G. M., Beaver, J. A., Pazdur, R.
The American Association for Cancer Research (AACR)
1078-0432
10780432
1557-3265
15573265
shingle_title_1 FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy
shingle_title_2 FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy
shingle_title_3 FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy
shingle_title_4 FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy
timestamp 2025-06-30T23:36:41.736Z
titel FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy
titel_suche FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy
topic WW-YZ
uid ipn_articles_6327872