Update: On June 29, the FDA Oncologic Drugs Advisory Committee voted unanimously to remove metastatic breast cancer from the label for Avastin. Read a response from the Ovarian Cancer National Alliance.
Dr. Robert Burger testified today 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 recent FDA ruling on 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.