By Admin at 25 Jan 2017, 14:11 PM

Women with advanced ovarian cancer may have a new option for treatment. The U.S. Food and Drug Administration (FDA) granted accelerated approval to Rubraca (rucaparib), a poly ADP-ribose polymerase (PARP) inhibitor.

Women with advanced ovarian cancer and deleterious BRCA gene mutation who have been treated with two or more chemotherapy regimens are eligible to receive the drug, which is a targeted agent designed specifically for ovarian cancer with this gene mutation.

BRCA genes normally help prevent the development of tumors by helping to repair damaged DNA. BRCA gene mutations, however, may promote tumor development. It’s estimated that up to 20 percent of women with ovarian cancer have a BRCA gene mutation.

Rubraca works by blocking an enzyme involved in repairing damaged DNA, which, according to the FDA, “leaves DNA inside the cancerous cells with damaged BRCA genes … less likely to be repaired, leading to cell death and possibly a slow-down or stoppage of tumor growth.”

Two clinical trials involving 106 women were used to gauge Rubraca’s safety and effectiveness. In the studies, 54 percent of women with BRCA-mutated advanced ovarian cancer who had been treated with two or more chemotherapy regimens experienced complete or partial shrinkage of their tumors. The benefit lasted a median of 9.2 months.

Serious risks, including myelodysplastic syndrome (a bone marrow problem), acute myeloid leukemia (blood cancer) and fetal harm, were noted, although common side effects were less severe and included:

Rubraca was granted accelerated approval because it offers a treatment that is reasonably likely to be beneficial for a serious or life-threatening condition. It will continue to be further studied both in patients with advanced ovarian cancer and those with other cancers.

The FDA also approved a companion diagnostic test for use alongside Rubraca — the FoundationFocus CDxBRCA test. This next-generation-sequencing-based test is used to detect deleterious BRCA gene mutations in ovarian tumors. If such mutations are detected, the patient may be eligible for treatment with Rubraca.

According to the American Cancer Society, about 22,280 women were diagnosed with ovarian cancer in 2016. It’s the ninth most common cancer among U.S. women but accounts for more cancer deaths than any other cancer of the female reproductive system.

Rubraca represents an additional targeted treatment option that may offer a significant benefit over other currently available therapies.

Sources
U.S. Food and Drug Administration December 19, 2016
American Cancer Society, Ovarian Cancer Statistics

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