Health knowledge and news provided by doctors.

FDA To Review Genentech's Avastin For Use As Breast Cancer Treatment

Armen Hareyan's picture

Genentech on Thursday announced that an FDAadvisory panel in December will review its colon and lung cancertreatment Avastin as a first-line treatment for metastatic breastcancer, Reuters reports (Baertlein, Reuters, 9/13).

Follow eMaxHealth on YouTube, Twitter and Facebook.
Please, click to subscribe to our Youtube Channel to be notified about upcoming health and food tips.

Genentechin May 2006 filed for FDA priority review of its application to useAvastin as a breast cancer treatment based on data from a late-stageclinical trial. The trial -- which involved 722 patients withpreviously untreated, locally recurrent or metastatic breast cancer --found that Avastin reduced the risk of disease progression or death by52% for patients who used the treatment with chemotherapy, comparedwith patients who only underwent chemotherapy.

Avastin -- which costs about $50,000 annually as a treatment for colon cancer -- might costas much as $100,000 to treat breast cancer because breast cancerpatients would require a double dose of the drug. FDA in September 2006requested that Genentech provide more thorough data than it gave in thelate-stage trial -- which was organized by National Cancer Institute researchers -- as well as require radiologists not involved in the trial to determine when patients' cancer has worsened (Kaiser Daily Women's Health Policy Report, 9/12/06).

According to Reuters,FDA's Oncologic Drugs Advisory Committee in December will consider theapplication. FDA is expected to take action on the application by Feb.23, 2008 (Reuters, 9/13). Avastin, which is approved as abreast cancer treatment in the European Union, increasingly is beingprescribed off-label to treat breast cancer, Dow Jones reports (Gryta, Dow Jones, 9/13).

Reprinted with permission from kaisernetwork.org. You can view theentire Kaiser DailyWomen's Health Policy Report, search the archives, and sign up for emaildelivery at kaisernetwork.org/email. The Kaiser Daily Women's Health Policy Report is published for kaisernetwork.org, afree service of The Henry J. Kaiser Family Foundation.