TY - JOUR
T1 - FDA approval summary
T2 - Rucaparib for the treatment of patients with deleterious BRCA mutation–associated advanced ovarian cancer
AU - Balasubramaniam, Sanjeeve
AU - Beaver, Julia A.
AU - Horton, Sara
AU - Fernandes, Laura L.
AU - Tang, Shenghui
AU - Horne, Hisani N.
AU - Liu, Jinzhong
AU - Liu, Chao
AU - Schrieber, Sarah J.
AU - Yu, Jingyu
AU - Song, Pengfei
AU - Pierce, William
AU - Robertson, Kim J.
AU - Palmby, Todd R.
AU - Chiu, Haw Jyh
AU - Lee, Eunice Y.
AU - Philip, Reena
AU - Schuck, Robert
AU - Charlab, Rosane
AU - Banerjee, Anamitro
AU - Chen, Xiao Hong
AU - Wang, Xing
AU - Goldberg, Kirsten B.
AU - Sridhara, Rajeshwari
AU - Kim, Geoffrey
AU - Pazdur, Richard
N1 - Publisher Copyright:
©2017 AACR.
Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2017/12/1
Y1 - 2017/12/1
N2 - On December 19, 2016, the FDA granted accelerated approval to rucaparib (RUBRACA; Clovis Oncology, Inc.) for the treatment of patients with deleterious BRCA mutation (germline and/or somatic)–associated advanced ovarian cancer who have been treated with two or more chemotherapies. The FDA also approved the FoundationFocus CDxBRCA test (Foundation Medicine, Inc.), the first next-generation sequencing-based companion diagnostic, for identifying patients with advanced ovarian cancer eligible for treatment with rucaparib based on detection of deleterious BRCA1 and/or BRCA2 mutations in tumor tissue. Rucaparib's approval was based primarily on efficacy data from 106 patients with BRCA mutation–associated ovarian cancer who had prior treatment with two or more chemotherapies and safety data from 377 patients with ovarian cancer treated with rucaparib 600 mg orally twice daily on two open-label, single-arm trials. Investigator-assessed objective response rate was 54% [57/106; 95% confidence interval (CI), 44–64], and median duration of response was 9.2 months (95% CI, 6.6–11.7). The approved companion diagnostic verified tumor BRCA mutation status retrospectively in 96% (64/67) of patients. Common adverse reactions (20%) to rucaparib were nausea, fatigue, vomiting, anemia, abdominal pain, dysgeusia, constipation, decreased appetite, diarrhea, thrombocytopenia, and dyspnea. This article summarizes the FDA review and data supporting rucaparib's accelerated approval.
AB - On December 19, 2016, the FDA granted accelerated approval to rucaparib (RUBRACA; Clovis Oncology, Inc.) for the treatment of patients with deleterious BRCA mutation (germline and/or somatic)–associated advanced ovarian cancer who have been treated with two or more chemotherapies. The FDA also approved the FoundationFocus CDxBRCA test (Foundation Medicine, Inc.), the first next-generation sequencing-based companion diagnostic, for identifying patients with advanced ovarian cancer eligible for treatment with rucaparib based on detection of deleterious BRCA1 and/or BRCA2 mutations in tumor tissue. Rucaparib's approval was based primarily on efficacy data from 106 patients with BRCA mutation–associated ovarian cancer who had prior treatment with two or more chemotherapies and safety data from 377 patients with ovarian cancer treated with rucaparib 600 mg orally twice daily on two open-label, single-arm trials. Investigator-assessed objective response rate was 54% [57/106; 95% confidence interval (CI), 44–64], and median duration of response was 9.2 months (95% CI, 6.6–11.7). The approved companion diagnostic verified tumor BRCA mutation status retrospectively in 96% (64/67) of patients. Common adverse reactions (20%) to rucaparib were nausea, fatigue, vomiting, anemia, abdominal pain, dysgeusia, constipation, decreased appetite, diarrhea, thrombocytopenia, and dyspnea. This article summarizes the FDA review and data supporting rucaparib's accelerated approval.
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U2 - 10.1158/1078-0432.CCR-17-1337
DO - 10.1158/1078-0432.CCR-17-1337
M3 - Short survey
C2 - 28751443
AN - SCOPUS:85031997808
VL - 23
SP - 7165
EP - 7170
JO - Clinical Cancer Research
JF - Clinical Cancer Research
SN - 1078-0432
IS - 23
ER -