TREATMENT CAN BE COMPLEX,INVOLVING A VARIETY OF THERAPIES

For patients with mCRPC, PARPis are a standard of care, along with androgen receptor-directed therapies^1-4

Source: Fig et al. Springer; 2010.

Rucaparib is indicated for patients previously treated with any androgen receptor-directed therapy and a taxane-based chemotherapy.⁵

See Important Safety Information for RUBRACA below.

Olaparib is indicated for the treatment of HRR-mutated mCRPC in combination with abiraterone and either prednisone or prednisolone, or as a monotherapy for patients with BRCA-mutated mCRPC who were previously treated with enzalutamide or abiraterone.⁶

Niraparib/abiraterone is a combination tablet of niraparib and abiraterone and is indicated in combination with prednisone for patients with BRCA-mutated mCRPC.⁷

Talazoparib is indicated in combination with enzalutamide for the treatment of adult patients with HRR-mutated mCRPC.⁸

Rucaparib is indicated for patients previously treated with any androgen receptor-directed therapy and a taxane-based chemotherapy.⁵

See Important Safety Information for RUBRACA below.

Niraparib/abiraterone is a combination tablet of niraparib and abiraterone and is indicated in combination with prednisone for patients with BRCA-mutated mCRPC.⁷

Talazoparib is indicated in combination with enzalutamide for the treatment of adult patients with HRR-mutated mCRPC.⁸

ELIGARD can be used as a foundation of treatment for advanced prostate cancer⁹

ELIGARD^® (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer.

ELIGARD may impair fertility in males of reproductive potential.

For Important Safety Information and full Prescribing Information for ELIGARD, visit EligardHCP.com.

Androgen receptor-directed treatments may have limitations for patients¹⁰

Changes in the androgen receptor signaling pathway are a major cause of androgen receptor antagonist resistance. In addition, androgen receptor-directed therapies may have side effects such as seizures and cardiovascular disease.

These events may cause androgen receptor-directed therapies to fail

PARPis induce DNA damage in BRCA-mutated tumor cells, resulting in tumor cell death^5,11,12*

Source: Zheng et al. Biomed Pharmacother. 2020;123:109661.

PARPis like RUBRACA offer a tolerable, efficacious, and flexible alternative to androgen receptor-directed therapies and are beneficial for patients with hereditary risk factors that predispose them to impaired DNA repair, such as BRCA mutations^5-8,13

*Based on in vitro studies.

Patients with BRCA1/2 mutations are at risk for more aggressive disease and poorer outcomes¹⁴

of patients with advanced prostate cancer have a BRCA1/2 mutation¹⁵

Genetic testing is recommended
by the National
Comprehensive Cancer Network^®for advanced prostate cancer¹⁶

Genetic testing is recommended by the National Comprehensive Cancer Network^®for advanced prostate cancer¹⁶

At the time of initial diagnosis, conduct germline testing in patients with:

Positive family history of prostate cancer
Ashkenazi Jewish ancestry
Personal history of breast cancer
High-risk, very high-risk, regional, or metastatic prostate cancer regardless of family history

At the time of metastatic diagnosis, conduct tumor testing for HRR mutations in patients with metastatic prostate cancer if not previously performed, with consideration of re-evaluation upon progression. Also consider:

Tumor mutational burden testing
Tumor testing for microsatellite instability (MSI) or deficient mismatch repair (dMMR)
Multigene molecular testing

NCCN is a trademark owned by the National Comprehensive Cancer Network^® (NCCN^®). 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.

Select patients for treatment with PARPis based on the presence of a deleterious BRCA mutation (germline and/or somatic)^5-8,16

Negative result from a plasma specimen does not mean that the patient’s tumor is negative for BRCA mutations⁵
If the plasma specimen has a negative result, consider performing further genomic testing using tumor specimens as clinically indicated⁵

Multiple genetic tests are commercially available to help you assess BRCA mutations in patients with prostate cancer.

If genetic testing confirms BRCA mutation in your patients with prostate cancer, consider treatment with RUBRACA⁵

VIEW THE EFFICACY DATA FOR RUBRACA

BRCA, BReast CAncer gene; CRPC, castration-resistant prostate cancer; DNA, deoxyribonucleic acid; DSB, double-strand break; HRR, homologous recombination repair; mCSPC, metastatic castration-sensitive prostate cancer; nmCRPC, non-metastatic castration-resistant prostate cancer; nmCSPC, non-metastatic castration-resistant prostate cancer; PARP, poly adenosine diphosphate-ribose polymerase; PSA, prostate-specific antigen; SSB, single-strand break.

REFERENCES: 1. Rebello RJ, Oing C, Knudsen KE, et al. Prostate cancer. Nat Rev Dis Primers. 2021;7(1):9. 2. Gillette CM, Yette GA, Cramer SD, Graham LS. Management of advanced prostate cancer in the precision oncology era. Cancers (Basel). 2023;15(9):2552. 3. Wahner A. OncLive. December 1, 2023. https://www.onclive.com/view/novel-combination-regimens-are-expanding-the-prostate-cancer-treatment-paradigm 4. Tawagi K, Schmolze M, Nguyen B, Laviana A, Reizine N. PARP inhibitors in prostate cancer – understanding the current landscape. IJCCD. 2024;4(1). 5. RUBRACA (rucaparib). Prescribing Information. pharma& Schweiz GmbH. 2023. 6. Lynparza (olaparib). Prescribing Information. AstraZeneca Pharmaceuticals LP. 2023. 7. Akeega (niraparib and abiraterone acetate). Prescribing Information. Janssen Biotech, Inc. 2023. 8. Talzenna (talazoparib). Prescribing Information. Pfizer Inc. 2024. 9. Eligard (leuprolide acetate). Prescribing Information. Tolmar, Inc. 2024. 10. Chen Y, Zhou Q, Hankey W, et al. Second generation androgen receptor antagonists and challenges in prostate cancer treatment. Cell Death Dis . 2022;13(7):632. 11. Messina C, Cattrini Ci, Soldato D, et al. BRCA mutations in prostate cancer: prognostic and predictive implications. J Oncol. 2020;4986365. 12. Zheng F, Zhang Y, Chen S, Weng X, Rao Y, Fang H. Mechanism and current progress of poly ADP-ribose polymerase (PARP) inhibitors in the treatment of ovarian cancer. Biomed Pharmacother. 2020;123:109661. 13. Tisseverashinghe S, Bahoric B, Anidjar M, Probst S, Niazi T. Advances in PARP Inhibitors for prostate cancer. Cancers (Basel). 2023;15(6):1849. 14. Na R, Zheng SL, Han M, et al. Germline mutations in ATM and BRCA1/2 distinguish risk for lethal and indolent prostate cancer and are associated with early age at death. Eur Urol. 2017;71(5):740-747. 15. Lozano R, Castro E, Aragón IM, et al. Genetic aberrations in DNA repair pathways: a cornerstone of precision oncology in prostate cancer. Br J Cancer. 2021;124(3):552-563. 16. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Prostate Cancer V.4.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed August 20, 2024. 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.  

Tap for safety information

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

RUBRACA^® (rucaparib) is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA.

This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

SELECT IMPORTANT SAFETY INFORMATION

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur in patients treated with RUBRACA, and are potentially fatal adverse reactions. In 1594 treated patients with ovarian cancer, MDS/AML occurred in 32 patients (2%), including those in long term follow-up. Of these, 14 occurred during treatment or during the 28-day safety follow-up (0.9%). The duration of RUBRACA treatment prior to the diagnosis of MDS/AML ranged from < 2 months to approximately 72 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing chemotherapy regimens and/or other DNA damaging agents.

In ARIEL3, of patients with a germline and/or somatic BRCA mutation treated with RUBRACA, MDS/AML occurred in 9 out of 129 (7%) patients treated with RUBRACA and 4 out of 66 (6%) patients treated with placebo. The duration of therapy with RUBRACA in patients who developed secondary MDS/cancer therapy-related AML varied from 1.2 to 4.7 years.

In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

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 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 findings from genetic toxicity and animal reproduction studies, RUBRACA can cause fetal harm. Advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of RUBRACA. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of RUBRACA.

Most common adverse reactions of patients with BRCA-mutated mCRPC in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

Concomitant administration of RUBRACA with CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates can increase the systemic exposure of these substrates, which may increase the frequency or severity of adverse reactions of these substrates. If concomitant administration is unavoidable between RUBRACA and substrates of these enzymes where minimal concentration changes may lead to serious adverse reactions, decrease the substrate dosage in accordance with the approved prescribing information.

If concomitant administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing the frequency of international normalized ratio (INR) monitoring.

For medical information inquiries within the U.S., contact pharma& at medinfo.us@pharmaand.com.

You may report adverse events to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Alternatively, to report an adverse event or reaction, contact pharma& by calling 1-800-506-8501 or emailing pv@pharmaand.com.

To report a product complaint, contact pharma& at complaints@pharmaand.com.

Please see full Prescribing Information for RUBRACA.

TREATMENT CAN BE COMPLEX,INVOLVING A VARIETY OF THERAPIES

For patients with mCRPC, PARPis are a standard of care, along with androgen receptor-directed therapies1-4

Androgen receptor-directed treatments may have limitations for patients10

Patients with BRCA1/2 mutations are at risk for more aggressive disease and poorer outcomes14

Genetic testing is recommended by the National Comprehensive Cancer Network® for advanced prostate cancer16

Genetic testing is recommended by the National Comprehensive Cancer Network® for advanced prostate cancer16

Select patients for treatment with PARPis based on the presence of a deleterious BRCA mutation (germline and/or somatic)5-8,16

VIEW THE EFFICACY DATA FOR RUBRACA

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

SELECT IMPORTANT SAFETY INFORMATION

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For patients with mCRPC, PARPis are a standard of care, along with androgen receptor-directed therapies^1-4

Androgen receptor-directed treatments may have limitations for patients¹⁰

Patients with BRCA1/2 mutations are at risk for more aggressive disease and poorer outcomes¹⁴

Genetic testing is recommended
by the National
Comprehensive Cancer Network^®for advanced prostate cancer¹⁶

Genetic testing is recommended by the National Comprehensive Cancer Network^®for advanced prostate cancer¹⁶

Select patients for treatment with PARPis based on the presence of a deleterious BRCA mutation (germline and/or somatic)^5-8,16

RUBRACA PATIENT WEBSITE
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RUBRACA PATIENT
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