2011.6.28 Ovarian Cancer National Alliance Urges FDA Not to Limit Access to Avastin (Bevacizumab) for Women with Ovarian Cancer


June 28, 2011

Ovarian Cancer National Alliance Urges FDA Not to Limit Access to Avastin (Bevacizumab) for Women with Ovarian Cancer

 Washington, DC—On Tuesday, June 28, Dr. Robert Burger testified before a Food and Drug Administration (FDA) panel on behalf of the Ovarian Cancer National Alliance. Dr. Burger, a gynecologic oncologist and Director of the Women’s Cancer Center at Fox Chase Cancer Center, spoke about the impact a proposed label change for the drug Avastin (bevacizumab) could have for women with ovarian cancer. In December 2010, the FDA announced that it intended to remove the metastatic breast cancer indication from the Avastin label. One reason for this decision is that Avastin showed an improvement in Progression Free Survival (PFS) for women with metastatic breast cancer in clinical trials, but did not show an improvement in Overall Survival (OS). Dr. Burger notes in his testimony that PFS may be the best available endpoint in clinical trials for ovarian cancer. If the FDA does not consider PFS a valid endpoint for clinical trials, that decision could affect approvals for drugs used in ovarian cancer.

Ovarian cancer is the deadliest gynecologic cancer and the fifth leading cause of cancer-related deaths among women. Three in four women with ovarian cancer will have a recurrence. In order to properly measure OS in a clinical trial for front line treatment, women would have to be denied further treatment if their ovarian cancer recurred. For this reason, many clinical trials instead measure PFS. Other endpoints used in ovarian cancer trials include CA-125 levels and Patient Reported Outcomes.

Dr. Burger’s testimony notes that several clinical trials involving Avastin have shown an improvement in PFS for women with recurrent ovarian cancer. The FDA’s decision to pull metastatic breast cancer from the Avastin label could make it difficult for ovarian cancer patients to access this therapy. The full text of Dr. Burger’s remarks is included below.

“Good morning. I am Dr. Robert Burger, a gynecologic oncologist, professor and Director of the Women’s Cancer Center at Fox Chase Cancer Center in Philadelphia. I have served as principal investigator for Phase II and Phase III trials of anti-angiogenic therapy in patients with ovarian cancer.

“I am here today on behalf of the Ovarian Cancer National Alliance, a patient advocacy group representing women and men whose lives have been touched by ovarian cancer. I serve on the Scientific and Medical Advisory Board of the Alliance.

“By way of disclosure, the Alliance works closely with Genentech/Roche, the manufacturers of bevacizumab, and with other pharmaceutical companies. We have received funding from this company in the past. Our working relationships in no way influence the positions stated below.

“We all agree that clinical trials are intended to be pure scientific experiments which must have valid endpoints. Progression-free survival, or PFS, is often the most objective and hence most valid primary endpoint in a clinical trial. For example, this is true for frontline Phase III trials of metastatic cancers where multiple active regimens have been demonstrated and where relatively long post-progression survival times have been noted. Considering the multitude of therapies stacked up throughout a disease history, it is becoming more and more difficult to demonstrate that any one active therapy can dramatically improve Overall Survival in a statistically significant sense. With numerous therapies available in metastatic or recurrent cancers, isolating a single agent as the sole variable responsible for an improvement in OS is difficult, if not impossible.

“We are in a new age in oncology where multiple active regimens exist for diseases like metastatic breast and ovarian cancers. For example, the National Comprehensive Cancer Network has listed single agent bevacizumab as a preferred regimen, among others, in the management of recurrent ovarian cancer. However, without Agency approval, the ability to prescribe this agent is limited, highly variable and discriminatory.

“The Alliance is here today because clinical trial data for ovarian cancer are not dissimilar to those for Her-2 negative metastatic breast cancer. Three Phase III clinical trials, two of them placebo-controlled, have demonstrated significant prolongation of PFS with the incorporation of bevacizumab in the primary and secondary treatment of advanced epithelial ovarian and related malignancies. In some cases, these trials have shown trends for prolongation of overall survival. In addition, a consensus statement by the Gynecologic Cancer Intergroup, a global consortium of cooperative groups, lists PFS as the preferred primary endpoint in frontline ovarian cancer Phase III trials, including those involving a maintenance component.

“We feel that if the Agency upholds its decision to disapprove the use of bevacizumab in the frontline treatment of metastatic breast cancer, this could have a negative impact for women with advanced or recurrent ovarian cancer. We urge you not to limit access to this clinically important agent.”

The Ovarian Cancer National Alliance is the foremost advocate for women with ovarian cancer in the United States. To advance the interests of women with ovarian cancer, the organization advocates at a national level for increases in research funding for the development of an early detection test, improved health care practices, and life-saving treatment protocols. The Ovarian Cancer National Alliance educates health care professionals and raises public awareness of the risks, signs and symptoms of ovarian cancer. The Ovarian Cancer National Alliance is a 501 (c) (3) organization established in 1997.



For more information, or to schedule an interview with Dr. Burger, please contact Amanda Davis at adavis@ovariancancer.org or (202) 331-1332.