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FORCE advocates for families facing hereditary breast and ovarian cancer in areas such as access to care, research funding, insurance, and privacy.

Our Role & Impact > Advocacy > Current Actions > FDA review of olaparib

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FDA review of olaparib

On December 19, 2014, the FDA announced approval of Lynparza (also known as olaparib) for women with BRCA mutations who have ovarian, fallopian tube or primary peritoneal cancer, and who have received three or more chemotherapy treatments. FORCE has been a strong advocate for PARP inhibitor research for nearly a decade. This is the first FDA-approved PARP inhibitor, and it is a great win for the HBOC and BRCA community.

FORCE was one of a handful of advocacy organizations to testify in favor of accelerated FDA approval of olaparib at the FDA hearing of the Oncology Drug Advisory Committee (ODAC) in June 2014. ODAC voted against approval at the conclusion of that meeting and early word from the FDA was that more research was needed before it would approve this therapy. The BRCA cancer community is grateful that the FDA reconsidered and approved this treatment.

PARP inhibitors are “targeted therapy” drugs that target tumors based on their unique biology. Developing these “smart” drugs requires a greater understanding of how cancer cells differ from other cells, and identifying cellular vulnerabilities. Targeted therapy uses specific treatments to attack the weaknesses of certain cancers based on their cellular genetic traits. PARP inhibitors block an enzyme used by cells to repair damage to their DNA. In people with BRCA mutations, PARP inhibitors may work by keeping cancer cells from repairing themselves once they’ve been damaged by chemotherapy, while sparing healthy cells.

Despite early positive findings, PARP inhibitor research almost came to a halt several years ago due in part to the challenge of studying drugs that may only benefit small subsets of a larger cancer patient population. Fortunately, thanks to champions within the scientific, advocacy and biotech communities, this important research continued. FDA approval of Lynparza is the culmination of these ongoing efforts, and hopefully only the beginning for this promising class of drugs. See our blog about this decision and read our article on this milestone.


Page updated 01/11/15

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