Published: Tue, December 20, 2016
Health | By Constance Griffith

FDA Approves Clovis Oncology's Ovarian Cancer Treatment

FDA Approves Clovis Oncology's Ovarian Cancer Treatment

Healthy BRCA genes are involved in repairing damaged DNA and typically work to prevent tumor and cancer development, but mutated forms of these genes can actually cause the disease.

More than 22,000 women are projected to be diagnosed with ovarian cancer this year, and more than 14,000 are projected to die from the disease, according to U.S. National Cancer Institute estimates cited by the FDA. However, mutations of these genes may lead to certain cancers, including ovarian cancers. Additionally, the cancer's BRCA status must be confirmed by a companion diagnostic test that the FDA approved at the same time. Rubraca is a poly ADP-ribose polymerase (PARP) inhibitor that blocks an enzyme involved in repairing damaged DNA.

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The agreement "demonstrates that with good will and respect it is possible to make progress and resolve differences", he noted.

Rubraca is created to inhibit a certain enzyme that's produced by a damaged BRCA gene. If one or more of the mutations are detected, the patient may be eligible for treatment with Rubraca.

Rucaparib received accelerated approval on the basis data from two single-arm clinical trials involving a total of 106 patients with advanced, previously treated, BRCA-mutant ovarian cancer. Ninety-six percent of tested trial participants using the FoundationFocus CDxBRCA companion diagnostic exhibited BRCA gene mutations in their tumor tissue. Fifty-four percent of participants given Rubraca had a complete or partial shrinkage of tumors, lasting an average of 9.2 months, the agency said. Rubraca is also associated with serious risks such as bone marrow problems, acute myeloid leukemia, and fetal harm. The Clovis drug targets a genetic mutation found in 15 to 20 percent of ovarian cancer patients. "This indication is approved under accelerated approval based on objective response rate and duration of response", the FDA said in a statement.

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