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New Indication for Rubraca® (rucaparib) tablets. Learn more
NOW APPROVED FOR MAINTENANCE THERAPY IN RECURRENT OC
Rubraca significantly extended PFS vs placebo,
regardless of BRCA status1
Results with Rubraca® (rucaparib) tablets in a 2:1 randomized, placebo-controlled, double-blind, multicenter phase 3 trial (N=564)1,2
  Primary Endpoint:
Investigator Assessment
Secondary Endpoint:
Independent Radiology Review
  Median PFS
Rubraca vs placebo
Reduction in risk
of disease progression or death
Median PFS
Rubraca vs placebo
Reduction in risk
of disease progression or death
Overall study population
(Rubraca, n=375)
(placebo, n=189)
10.8 vs 5.4
months
64%
HR=0.36
(95% CI, 0.30-0.45); P<0.0001
13.7 vs 5.4
months
65%
HR=0.35
(95% CI, 0.28-0.45); P<0.0001
BRCAmut+ population
(Rubraca, n=130)
(placebo, n=66)
16.6 vs 5.4
months
77%
HR=0.23
(95% CI, 0.16-0.34); P<0.0001
26.8 vs 5.4
months
80%
HR=0.20
(95% CI, 0.13-0.32); P<0.0001
No companion diagnostic required to use Rubraca in the maintenance setting1
ARIEL3 study design:
Maintenance therapy with Rubraca 600 mg BID was investigated in a randomized, placebo-controlled, double-blind, multicenter clinical trial in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (N=564). Patients were randomized 2:1 to receive Rubraca or placebo until unacceptable toxicity or progressive disease. All patients had received ≥2 prior platinum-containing regimens and were in a complete or partial response to their most recent platinum-based therapy. Primary endpoint: PFS by investigator assessment analyzed in 3 prospectively defined molecular subgroups in a step-down manner: 1.) BRCAmut+ patients, 2.) HRD+ patients, and 3.) all randomized patients. PFS by IRR was a secondary endpoint.1,2 Both primary and secondary endpoints were assessed according to RECIST v1.1.1,3
BID=twice a day; BRCA=breast cancer susceptibility gene; BRCAmut+=BRCA-mutation positive, which includes mutations in the BRCA1 and/or BRCA2 gene; HRD+=homologous recombination deficiency positive; IRR=independent radiology review; HR=hazard ratio; PFS=progression-free survival; RECIST=Response Evaluation Criteria In Solid Tumors.
 * In adult patients with platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer who have had a complete or partial response after 2 or more lines of platinum-based therapy, including the most recent line.
SELECT IMPORTANT SAFETY INFORMATION
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) occurred in patients exposed to Rubraca, and some cases were fatal. Monitor patients for hematological toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed.
Rubraca can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.
Access and support
Rubraca offers flexible access options: simply send your Rubraca prescriptions to either a network specialty pharmacy or your in-office dispensing (IOD) pharmacy. Commercially insured patients who need co-pay assistance are eligible to enroll in the Rubraca $0 Co-Pay Program; other programs are available for government and uninsured patients, too.
You can also digitally enroll qualifying patients in these financial support programs and/or prescribe Rubraca online through Rubraca eRx and eSupport Solutions. Visit www.RubracaConnections.com to learn more about all the options and support for accessing Rubraca.
Learn more at www.rubracahcp.com
INDICATION
Rubraca is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
SELECT IMPORTANT SAFETY INFORMATION
Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur uncommonly in patients treated with Rubraca, and are potentially fatal adverse reactions. In approximately 1100 treated patients, MDS/AML occurred in 12 patients (1.1%), including those in long term follow-up. Of these, 5 occurred during treatment or during the 28 day safety follow-up (0.5%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 28 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents.
Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1).
Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose (see Dosage and Administration (2.2) in full Prescribing Information) and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.
Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca.
Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%), and neutropenia (20%).
Most common laboratory abnormalities in ARIEL3 (≥ 25%; Grade 1-4) were increase in creatinine (98%), decrease in hemoglobin (88%), increase in cholesterol (84%), increase in alanine aminotransferase (ALT) (73%), increase in aspartate aminotransferase (AST) (61%), decrease in platelets (44%), decrease in leukocytes (44%), decrease in neutrophils (38%), increase in alkaline phosphatase (37%), and decrease in lymphocytes (29%).
Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.
Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose.
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Clovis Oncology, Inc. at 1-844-258-7662.
Please see full Prescribing Information for additional Important Safety Information.
References: 1. Rubraca [prescribing information]. Boulder, CO: Clovis Oncology; 2018. 2. Coleman RL, Oza AM, Lorusso D, et al; for the ARIEL3 investigators. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017;390(10106):1949-1961. 3. Coleman RL, Oza AM, Lorusso D, et al. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a phase 3, international, randomised, double-blind trial. Online supplementary appendix. Lancet. 2017. Accessed February 20, 2018. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer V.2.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed April 9, 2018. To view the most recent and complete version of the guideline, go online to NCCN.org . NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
clovis
rubraca
© 2018 Clovis Oncology.     PP-RUCA-US-0592   05/2018



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