Robert Burger, MD, Director, Women’s Cancer Center at Fox Chase Cancer Center

Last summer, an advisory committee to the U.S. Food and Drug Administration (FDA) voted 12 to 1 against the full approval of Avastin, a drug used to treat some but not all forms of cancer, for the treatment of advanced and metastatic breast cancer. This was not the final word, and many oncologists and patients have been waiting for further decisions regarding Avastin and breast cancer.

Then, in June 2011, another FDA panel voted unanimously to revoke Avastin’s approval for treating metastatic breast cancer. The drug was deemed “unsafe and ineffective” by the six-member panel. Again, patients should be aware that this decision is not the final word on Avastin. FDA Commissioner Margaret Hamburg will make the decision sometime after July 28, 2011.

The FDA began taking steps to revoke Avastin’s approval for breast cancer patients back in 2010, but Roche, the pharmaceutical company that manufactures the drug, appealed the decision and lobbied for a second hearing. While Avastin might not have any noticeable or measurable benefits for breast cancer patients, the drug is still an important option for the treatment of cancer. The FDA has approved the drug for treating patients with colon, lung, kidney and brain cancer.

At Fox Chase, my research has shown some very encouraging results when it comes to prescribing Avastin for the treatment of ovarian cancer. (See last year’s article in this blog). Last month, I was invited to testify before the FDA panel in this latest hearing. While my research is primarily focused on ovarian cancer, I cautioned the panel that that Avastin might have benefits beyond prolonging overall survival in breast cancer patients.

Read my complete testimony here (June 28, 2011). In my testimony, I noted that several clinical trials involving Avastin have shown 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 potentially beneficial therapy.

According to the Ovarian Cancer National Alliance, “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.”

Many patients have taken Avastin for breast cancer who have seen positive results, and many of them are understandably concerned by this news. Even if Commissioner Hamburg makes the final decision to revoke Avastin’s approval, it doesn’t mean that Avastin will never again be prescribed for breast cancer patients. However, without FDA approval, it is much less likely that the drug would be covered by health insurance.

Paula D Ryan, MD, PhD

As a surgeon who specializes in gynecologic malignancies, I thought it would be helpful to invite my colleague, Paula D. Ryan, MD, PhD, a medical oncologist who specializes in breast cancer, to share her thoughts on the topic:

“So is this bad news for breast cancer patients? In general the answer is no!”

“The available data suggests that for most women the response of their tumor to Avastin will likely be modest in both magnitude and duration and will come at the risk of potentially significant toxicity and significant cost that patients either directly or indirectly need to cover. Yet some patients, probably a small minority, have more durable responses.

Ideally patients, physicians, and regulatory groups would work together to determine which small subset of patients are likely to enjoy the benefit. Indeed, we currently have good tests for predicting responses to drugs such as tamoxifen and Herceptin but alas the equivalent predictive test doesn’t exist for Avastin.

The ongoing use of Avastin in colon cancer and a variety of other cancers offers the hope that a test may one day be available to identify those patients in whom Avastin may be a life prolonging drug. If that test were to become available it is likely the research examining Avastin in breast cancer would be invigorated. Until then, it is probably more beneficial that women search for options for the treatment of their advanced breast cancer and should consider participation in carefully designed clinical trials.”

As I’ve stated before, Avastin is just one treatment option that has been used in recent years for breast cancer.  It’s important that patients discuss as many different treatment options as possible with their treating physicians. We know that no two cases of breast cancer are exactly alike and that patients respond differently to each treatment option. I encourage you to talk to your physician about specific concerns, or post your questions here.

Be well,
Bob