Today is a landmark for the HBOC community!
After almost a decade of research, AstraZeneca has received FDA approval for Lynparza (also known as olaparib) for women with BRCA mutations who have ovarian, fallopian tube or primary peritoneal cancer, and who responded favorably to their initial treatment. This is the first FDA-approved PARP inhibitor, and it is a great win for the HBOC and BRCA community.
FORCE has been passionately advocating for PARP inhibitor research for the last eight years. At our Joining FORCEs conference in 2009, during our hereditary cancer research plenary, I made a personal vow to our community that FORCE would work tirelessly and do whatever it took to assure that the clinical trials on PARP inhibitors were fully enrolled, that the research was completed, and—if the agents worked—that we would advocate for FDA approval.
This past June, we were one of a handful of advocacy organizations to testify at the FDA hearing of the Oncology Drug Advisory Committee (ODAC) in favor of accelerated FDA approval of this agent. Early word from the FDA was that more research was needed before it would approve olaparib.
PARP inhibitors are “targeted therapy” drugs that target tumors based on their specific 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 unique 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 challenges arising from studying drugs that may only benefit small subsets of a larger cancer patient population. Fortunately, due to champions within the scientific, advocacy and biotech communities, the important research continued. FDA approval of Lynparza is the culmination of these ongoing efforts.
There is still much work to be done. Many clinical trials are enrolling cancer patients to pinpoint the best time to start treatment with PARP inhibitors in patients with ovarian cancer; determine whether these agents work equally well for BRCA-associated breast, pancreatic, and other cancers; and identify whether these agents benefit people who do not have BRCA mutations. We still desperately need our community to participate in these ongoing research studies. Still, FDA approval of olaparib for ovarian cancer sends an encouraging message to researchers that we hope will lead to new innovations for more effective detection, prevention and treatment for people with hereditary cancers.
This is an amazing holiday gift and game-changer for all members of our community. Oncologists now have a new weapon for treating hereditary ovarian cancer. This news will likely produce other benefits as well. We will undoubtedly see an increased uptake of genetic counseling and testing among women who are diagnosed with ovarian cancer, and whose treatment may be impacted by whether or not they carry a mutation. Identifying more people with a BRCA mutation will increase the numbers of people who can take part in lifesaving HBOC research. Having more people who are aware of their positive BRCA status will grow our community, increasing members who can advocate for positive change through resources, policy, and research. Finally, identifying more people who have BRCA mutations will raise the profile of hereditary cancer in the public eye.
On a personal note, as a cancer survivor, a person with a BRCA mutation, a relative of other high-risk family members, and a friend of people currently battling advanced hereditary cancer, this news gives me hope and comfort. Yet even as I celebrate with the community, I need to pause and reflect on the many brave and cherished soles for whom this progress did not come soon enough; Sherry Pedersen, Caryn Rosenberg, Linda Pedraza, Jan Finer, Debra Brooks, and too many more to name. You have all touched me in a profound way and inspired me to work harder to accelerate progress in HBOC research.
Finally, I would like to acknowledge all who played a role in this achievement: the scientists who work tirelessly to advance cancer research, the foundations and agencies that direct funding to HBOC research, the biotech companies that invest in greater options for this subset of the larger cancer community, and the brave people who volunteered for PARP inhibitor research studies. From the bottom of my heart…thank you!
Tags: brca, BRCA 1, BRCA 2, brca testing, BRCA1, BRCA2, breast cancer, facingourrisk, FDA, gene testing, screening and prevention