FDA Changes Ruling on Drug to Treat Breast Cancer

Avastin (bevacizumab), a medication used to treat a certain type of brain cancer and cancers of the kidney, lung, rectum and colon -- and recently, breast cancer -- is not being recommended by the U.S. Food and Drug Administration as of Dec.16.

The FDA reports that Genentech, the pharmaceutical manufacturer of Avastin, has 15 days in which to appeal this decision by the FDA. During this time period, it is unlikely that Avastin will lose its current approval for use in the treatment of breast cancer. Genentech is a subsidiary of the Swiss pharmaceutical company Roche. Bevacizumab in its many uses is the top-selling medication for Roche, bringing in $6.5 billion in revenue in 2009, according to Bloomberg Business Week.

Noteworthy is that on the same date, the European Union's Committee for Medicinal Products for Human Use (CHMP) lauded the virtues of Avastin's use in treatment of breast cancer as long as it is used with another cancer treatment drug, paclitaxil. CHMP issued a statement that the benefits of bevacizumab outweigh its risks and is useful in the treatment of metastatic breast cancer. The committee concluded that Avastin should no longer be used in combination with Taxotere (docetaxel), another anti-cancer medication.

Chemotherapy treatments often combine two or three medications to fight the cancer at hand.

Avastin "Fast-tracked" Approval for Use against Breast Cancer

In 2008, Avastin received accelerated approval by the FDA for use against metastatic breast cancer based on clinical data provided by Genentech that demonstrated "progression-free survival" in study participants who had received the drug. Progression-free survival is an important indicator to the FDA of a cancer drug's effectiveness. The term indicates a longer span of time with no tumor growth which can lead also to an improved quality of life for the patient.

The accelerated approval process requires backup by additional clinical data. In its Dec. 16 report, the FDA cites results of four recent clinical studies which showed minimal to no effectiveness of the drug to decrease tumor size in breast cancer.

Severe Side Effects

In addition to Avastin's failure to control tumor growth associated with metastatic breast cancer, the FDA cites the drug's serious side effects as another reason it determined that risks outweighed benefits. The FDA lists side effects ranging from high blood pressure and nose bleeds as the most common, to massive bleeding that requires blood transfusions, holes developing in the body, myocardial infarction, stroke and kidney damage as less common side effects.

While it is understood that chemotherapy drugs bring with them their own sets of side effects, when the risks of bevacizumab were weighed against the minimal to absent benefits in breast cancer treatment, the FDA moved to revoke its conditional approval for that indication.

Bottom Line

Bloomberg Business Week reports that Roche intends to appeal the FDA's decision. To do so, the company will need to provide clinical data that demonstrates Avastin's effectiveness in treating tumors related to metastatic breast cancer. The FDA recommends that women currently receiving treatment with Avastin for their breast cancer consult their oncologist.

It's likely that the CHMP's data, if different from the FDA's, will be used in Roche's appeal. If the clinical study results both organizations used to make their determinations are the same, does it mean the FDA is more proactive than its European counterpart -- or are other forces at work?

Sources: "Questions and Answers about Avastin"; U.S. Food and Drug Administration.
Dermot Doherty; "EU to Limit Use of Roche's Avastin in Breast Cancer"; Bloomberg Business Week, Dec. 16, 2010.
"CHMP OKs Avastin Use for Breast Cancer"; NASDAQ; Dec. 16, 2010.
Andrew Pollack; "FDA Rejects Use of Avastin in Breast Cancer"; New York Times Business Feed; Dec. 17, 2010.