Rubraca (rucaparib)

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Rubraca (rucaparib)

Rubraca (rucaparib) is a medication used for the treatment of ovarian, fallopian tube and primary peritoneal cancer.

How to buy Rubraca (
rucaparib): You can order Rubraca (rucaparib) from TheSocialMedwork if the drug has not been approved or is not available in your country. 

Oncology Gynaecological Cancer
Marketing Authorisation Holder Clovis Oncology, Inc.
Mode of Action PARP inhibitor
Administration Oral
Regulatory agency approval Food and Drug Administration (FDA), USA
Package 60 Tablets

What is Rubraca (rucaparib) for?

Rubraca (rucaparib) is indicated as monotherapy 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 chemotherapies1Patients should be selected for therapy based on the FDA-approved FoundationFocus CDxBRCA test (Foundation Medicine Inc.)2,1Approximately 15 to 20% of patients with ovarian cancer have a BRCA gene mutation3.

  • 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 chemotherapy1.

How does Rubraca (rucaparib) work?

BRCA genes are involved with repairing damaged DNA and normally work to prevent tumour development. However, mutations of these genes may lead to certain cancers, including ovarian cancers. Rubraca (rucaparib) is a poly ADP-ribose polymerase (PARP) inhibitor that blocks an enzyme involved in repairing damaged DNA. By blocking this enzyme, DNA inside the cancerous cells with damaged BRCA genes may be less likely to be repaired, leading to cell death and possibly a slowdown or stoppage of tumour growth3.

Where has Rubraca (rucaparib) been approved?

Rubraca (rucaparib) was approved by:

  • Food and Drug Administration (FDA), USA: 
    • on December 19, 2016, 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 chemotherapies1
    • on April 6, 2018, for the 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 chemotherapy1.

How is Rubraca (rucaparib) taken?

The standard dosage is:

  • 600 mg orally twice daily.

Patients should be monitored for hematologic toxicity at baseline and monthly thereafter, and use of Rubraca (rucaparib) should be discontinued if myelodysplastic syndrome (MDS) / acute myeloid leukemia (AML) is confirmed1.

Complete information about Rubraca (rucaparib) dosage and administration can be found in the resources section. 

Note: Consult your treating doctor for personalised dosing.

Are there any known side effects or adverse reactions of Rubraca (rucaparib)?

Common adverse reactions

The most common adverse reactions listed in the prescribing information include:

  • nausea
  • fatigue
  • vomiting
  • anemia
  • abdominal pain
  • dysgeusia (distortion of the sense of taste)
  • constipation
  • decreased appetite
  • diarrhoea
  • thrombocytopenia (deficiency of platelets in the blood)
  • dyspnea (difficult breathing)1.

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:

  • myelodysplastic syndrome/acute myeloid leukemia (MDS/AML).

Use in specific populations

Rubraca (rucaparib) can be fatal for a fetus, it is advised to avoid pregnancies and breast feeding.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1.



More Information
Working ingredient rucaparib
Shipping method Controlled room temperature (temperature controlled)
Package 60
Therapeutic Area Oncology
Oncology Gynaecological Cancer
Indication BRCA+ ovarian cancer, Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
Administration Oral
Mode of Action PARP inhibitor
Regulatory agency approval Food and Drug Administration (FDA), USA
Marketing Authorisation Holder Clovis Oncology, Inc.

BRCA-mutated Ovarian Cancer (treatment)

The approval by the Food and Drug Administration (FDA), USA, of Rubraca (rucaparib) for the treatment of BRCA-mutated ovarian cancer as 3rd line treatment was based on two single-arm (no comparator) open-label clinical trials (Study 10 (NCT01482715) and ARIEL2 (NCT01891344). These studies involved a total of 106 adults with advanced BRCA-mutated ovarian cancer who had been treated with two or more chemotherapy regimens but progressed on or after these1. BRCA gene mutations were confirmed in 96% of tested trial participants with available tumour tissue using the FDA approved diagnostic FoundationFocus CDxBRCA2. All patients received Rubraca (rucaprib) as monotherapy until disease progression or unacceptable toxicity1.

Results

Among the efficacy outcome measures were the objective response rate (ORR) and the duration of response (DOR).

The ORR was1:

  • 54% [95% CI: 44, 64]
  • with 9% compete responses

The median DOR was1:

  • 9.2 months [95% CI: 6.6, 11.6]


On October 12, 2012, the European EMA granted orphan designation to Clovis Oncology UK Limited, United Kingdom, for rucaparib for the treatment of ovarian cancer5, and in March 2018 the European Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Rubraca, intended for the treatment of relapsed or progressive ovarian cancer6.

Recurrent Ovarian Cancer (maintenance treatment)

The approval by the Food and Drug Administration (FDA), USA, of Rubraca (rucaparib) 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 was based on a double-blind, multicentre clinical trial (ARIEL3 (NCT01968213)). This study involved a total of 564 patients who were in response to platinum-based chemotherapy. Patients received either Rubraca tablets 600 mg orally twice daily (n=375) or placebo (n=189). Treatment was continued until disease progression or unacceptable toxicity1.

Results

Among the efficacy outcome measures was the progression-free survival in all patients and in two subgroups: homologous recombination deficiency (HRD) (HRD group) and positive deleterious BRCA mutation (tBRCA group).

The median PFS was1:

  • among all patients
    • 10.2 months with Rubraca (rucaparib) 
    • 5.4 months with placebo
  • in the HRD group:
    • 13.6 months with Rubraca (rucaparib) 
    • 5.4 months with placebo
  • In the tBRCA group:
    • 16.6 months with Rubraca (rucaparib)
    • 5.4 months with placebo

1. Summary of Product Characteristics [FDA]: Rubraca (rucaparib) [PDF]
    Clovis Oncology Inc., Dec. 2016

2. Foundation Focus CDXBRCA
    Foundation Medicine, cited Jan 2017

3. FDA grants accelerated approval to new treatment for advanced ovarian cancer
    FDA, Dec 2016

4. Approved Drugs: Rucaparib
    FDA, Dec 2016

5. Rare disease designations: EU/3/12/1049
    EMA, cited Jan 2017

6. Pending EC decisions: Rubraca
    EMA, 22/03/2018.


Shipping Type Standard
Shipping method Controlled room temperature (temperature controlled)
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.