U.S FDA assigned accelerated approval pathway to new medicine Rubraca that contains active ingredient rucaparib for the treatment of various types of ovarian cancer. According to FDA guidelines this drug should be used in progressive or advance type of ovarian cancer.
According to statistical data ovarian cancer is one of most leading type of cancer in women with high mortality rate. Ovarian cancer has multiple types some of which are idiopathic while others are due to mutation in specific genes e.g BRCA gene. Statistics shows that in United states approximately 20,000 to 22,000 women diagnosed with ovarian cancer annually and about 60 to 70 percent of these women die due to ovarian cancer. In united states most majority of women have ovarian cancer due to mutation of BRCA gene.
Rubraca/rucaparib achieved accelerated approval pathway due to its targeted action. Normally BRCA genes involves in the development of DNA but due to mutation in BRCA genes they produce altered DNA and give rise to tumor cells. rubraca/rucaparib works by blocking the enzyme (polymerase) that is necessary for DNA replication. This blockade will restrict the process of DNA replication or repairing, leading to cell death and possibly a slow-down or stoppage of tumor growth.
Rubraca/rucaparib Side effects
During clinical trails following side effects were reported in patient who were receiving this medicine
- Low platelets count
- Decrease in red blood cells
- Difficulty in breathing
- Changes in taste sensation
- Skin rashes
Rubraca/rucaparib Uses or Prescribing Information
U.S FDA granted its use in women who have advance ovarian cancer and one or more of the mutations of BRCA genes are detected, the patient may be eligible for treatment with Rubraca. However drug should be used with caution in patients who have bone marrow problem because this drug may cause myelodysplastic syndrome in those patients. This drug is not safe for fetus development so, always consult with your health care provide (hcp) before starting any medicine.
This drug is manufacturing in the form of tablets (Oral dosage form) with potency of 200mg and 300mg. Standard dosage frequency of Rubraca/rucaparib is 300mg tablet twice a day (BID) daily until disease progression reduced to maximum level. Dose adjustment may be required in case of severe side effects, hepatic or renal impairment. Safety profile of this drug has not yet evaluated in children.