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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.

Advocacy > Current Actions > FDA Review of Olaparib

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Newsflash

9/22/17
Check out this new video w/FORCE & 15 other cancer orgs representing patients, physicians, nurses, & social workers. Oppose Graham-Cassidy! See Video...

9/14/17
FORCE reps were in St. Louis today for an ICER hearing on the value and cost of PARP inhibitors for ovarian cancer patients.

9/13/17
Advocates took part in the Rally for Medical Research Capitol Hill Day Training, preparing them to advocate for increased NIH research funding.

9/13/17
FORCE participated in the Blueprint for Breakthroughs: Charting the Course for Precision Medicine workshop, providing the perspective of the patient community.

8/9/17
Today, FORCE submitted comments to ICER expressing concerns about its draft report “Poly ADP-ribose polymerase (PARP) Inhibitors for Ovarian Cancer: Effectiveness and Value.”

7/25/17
A FORCE rep spoke today about effectively working with patient groups at the 13th annual Medical Device Coverage & Reimbursement conference.

7/11/17
We joined 133 orgs in supporting the I Am Essential coalition letter in response to the HHS RFI on how to "create a more flexible, streamlined approach to the regulatory structure of the individual and small group markets."

6/15/17
Lisa Schlager, FORCE VP of Community Affairs & Public Policy, attended the NCCN Policy Summit on Ensuring Patient Safety and Access in Cancer Care.
Summit Overview

6/12/17
FORCE joined 60 other orgs in a letter to the FDA with comments on the proposed Office of Patient Affairs.
Read comments...

5/23/17
FORCE joined The Ad Hoc Group for Medical Research, representing over 300 organizations, in recommending a $2 billion FY18 increase for NIH, in addition to funds included in the 21st Century Cures Act for targeted initiatives.

 

FDA Review of Olaparib

Unfortunately, ODAC voted against approval of olaparib at the conclusion of the June 25, 2014 hearing. While olaparib showed improvement in progression-free survival, it did not show an improvement in overall survival for the women who took it in the clinical trials. Because there are no approved maintenance drugs currently on the market for ovarian cancer, the trials compared the side effects of olaparib to a placebo (i.e. no treatment at all). Olaparib had more side effects and adverse events than the placebo, so the advisory committee decided the benefits didn't outweigh the risks.

The panel did not take into account the fact that taking olaparib delays a woman's need to go back on chemotherapy; a treatment shown to be more toxic than olaparib. While this vote is not the final decision, the FDA will likely follow ODAC's recommendation and the therapy will be reconsidered after the conclusion of additional research. See our blog about this decision and learn more about PARP inhibitors.

Page updated 7/28/14

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