What are the possible benefits of taking Rubraca (rucaparib) tablets?

Rubraca works when your tumor starts to grow again

The effectiveness of Rubraca (rucaparib) tablets was evaluated in 106 women from 2 clinical studies.
In women with BRCA mutation–positive (BRCAmut+) advanced ovarian cancer who had received at least 2 prior chemotherapy medicines,

As reported by the studies' doctors:

More than half of women saw their tumors shrink with Rubraca treatment

  • Rubraca caused tumors to shrink in 54% of patients (95% CI; 44-64)*
  • Of the patients who responded to Rubraca, 9% had a complete response and 45% had a partial response. A complete response is not the same thing as a cure
  • Not all women saw their tumors shrink or responded to Rubraca treatment
54% of 106 women saw tumors shrink (95% CI; 44-64)

Median length of response to treatment with Rubraca was 9.2 months

  • In women who participated in the rucaparib clinical trials, of those who responded to Rubraca, half showed a response to treatment that was less than 9.2 months while half of the women showed a response that was longer than 9.2 months (95% CI; 6.6-11.6)*
Median length of response to treatment with Rubraca was 9.2 months (95% CI; 6.6-11.6)

In a separate review by independent doctors not involved in the clinical studies, Rubraca caused tumors to shrink in 42% of patients (95% CI; 32-52).* Of those who responded, half showed a response to treatment that was less than 6.7 months while half of the women showed a response that was longer than 6.7 months (95% CI; 5.5-11.1).*

*There is a 95% chance that the confidence interval (range of numbers or percentages) may include the true mean of all the women in the study.
Median is a middle point of a range of numbers, half of which are above the middle point, half of which are below it.

BRCA, Breast Cancer susceptibility gene.


Rubraca (rucaparib) tablets may cause serious side effects including a bone marrow disorder called Myelodysplastic Syndrome (MDS) or a type of cancer of the blood called Acute Myeloid Leukemia (AML). Some people who have ovarian cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during or after treatment with Rubraca. MDS or AML may lead to death. If you develop MDS or AML, your doctor will stop treatment with Rubraca.

Symptoms of low blood cell counts are common during treatment with Rubraca but can be a sign of serious problems, including MDS or AML. Tell your doctor if you have any of the following symptoms during treatment with Rubraca:

  • weakness
  • weight loss
  • fever
  • frequent infections
  • blood in urine or stool
  • shortness of breath
  • feeling very tired
  • bruising or bleeding more easily

Your doctor will do blood tests before, and every month during, treatment with Rubraca to monitor your blood cell counts. Weekly blood tests will be performed if you have low blood cell counts for a long time. Your doctor may stop treatment with Rubraca until your blood cell counts improve.

Before you take Rubraca, tell your doctor about all of your medical conditions, including if you:

  • are pregnant or plan to become pregnant. Rubraca can harm your unborn baby and may cause loss of pregnancy (miscarriage). You should not become pregnant during treatment with Rubraca.
    • If you are able to become pregnant, your doctor may do a pregnancy test before you start treatment with Rubraca.
    • Females who are able to become pregnant should use effective birth control during treatment and for at least 6 months after receiving the last dose of Rubraca.
    • Talk to your doctor about birth control methods that may be right for you.
    • Tell your doctor right away if you become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if Rubraca passes into your breast milk. Do not breastfeed during treatment and for 2 weeks after the last dose of Rubraca.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

While taking Rubraca, avoid spending time in sunlight. Rubraca can make your skin sensitive to the sun (photosensitivity). You may burn more easily during treatment with Rubraca. You should wear a hat and clothes that cover your skin and use sunscreen to help protect against sunburn if you have to be in the sunlight.

The most common side effects of Rubraca include:

  • nausea
  • fatigue
  • vomiting
  • stomach-area pain
  • changes in how food tastes
  • constipation
  • decreased appetite
  • diarrhea
  • shortness of breath
  • decrease in hemoglobin (anemia)
  • low blood cell counts
  • changes in liver or kidney function blood tests
  • increased cholesterol levels

These are not all of the possible side effects of Rubraca. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

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, including Patient Information, for additional Important Safety Information.