Rubraca (rucaparib)

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Rubraca (rucaparib)

How to buy Rubraca: You can order Rubraca (rucaparib) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Clovis Oncology Inc.
Disease Ovarian Cancer
Indication Deleterious BRCA mutation associated with advanced ovarian cancer
Mode of Action PARP inhibitor
Approval Status FDA approved (USA)
CAS Number 89-25-8
HS Code 29331990
Strength 300 mg, 200 mg

Who is 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 chemotherapies [1]. Patients should be selected for therapy based on the FDA-approved FoundationFocus CDxBRCA test (Foundation Medicine Inc.) [2][1].

Recommended dose

Complete information about Rubraca (rucaparib) dosage and administration can be found here [1].
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 confirmed [1].
Consult your treating doctor for personalised dosing.

What is rucaparib and how does it work?

Rubraca (rucaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor 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 chemotherapies [1]. Approximately 15 to 20 % of patients with ovarian cancer have a BRCA gene mutation. 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 growth [3].

What is rucaparib's approval status?

Rubraca (rucaparib) was approved by:
  • 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 chemotherapies [1].
The approvals were based on a study involving 106 adults with BRCA-mutated advanced ovarian cancer who had been treated with two or more chemotherapy regimens. BRCA gene mutations were confirmed in 96 % of tested trial participants with available tumour tissue using the FDA approved diagnostic FoundationFocus CDxBRCA [2]. Of the participants who received Rubraca (rucaparib) in the trials, 54 % experienced complete or partial shrinkage of their tumours lasting a median of 9.2 months [4].
The safety of Rubraca (rucaparib) was evaluated in 377 patients with advanced ovarian cancer. The most common adverse reactions (greater than or equal to 20 %) experienced by patients were nausea, fatigue, vomiting, anemia, abdominal pain, dysgeusia, constipation, decreased appetite, diarrhea, thrombocytopenia, and dyspnea. MSD/AML was reported in 2 out of 377 (0.5 %) patients with ovarian cancer. In addition, AML was reported in 2 (<1 %) patients with ovarian cancer enrolled in a blinded, randomised trial evaluating rucaparib versus placebo [4].
On October 12, 2012, the European EMA granted orphan designation to Clovis Oncology UK Limited, United Kingdom, for rucaparib for the treatment of ovarian cancer [5].
References
[1] Summary of Product Characteristics [FDA]: Rubraca (rucaparib), Clovis Oncology Inc., Dec. 2016.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209115s000lbl.pdf
[2] Foundation Medicine. Foundation Focus CDXBRCA. Cited on 30/01/2017.
http://www.foundationmedicine.com/genomic-testing/foundation-focus
[3] FDA News Release: FDA grants accelerated approval to new treatment for advanced ovarian cancer, 19/12/2016.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm533873.htm
[4] FDA. Approved Drugs: Rucaparib, 19/12/2016.
http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm533891.htm
[5] EMA. Rare disease designations: EU/3/12/1049, 16/11/2012, cited on 30/01/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2012/11/human_orphan_001123.jsp&mid=WC0b01ac058001d12b








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