Avastin: The Confusion Continues

By Ilene Winkler

From Mets Matters Blog

The FDA has granted Genentech a hearing on its appeal of the agency's decision to remove accelerated approval of Avastin for first-line treatment of metastatic breast cancer. The hearing will be on June 28-29. The FDA had earlier given accelerated approval of Avastin in combination with paclitaxel (Taxol) but in December, 2010 recommended that the approval be withdrawn  when they determined that Genentech's subsequent confirmatory trials of Avastin did not support their original decision. Avastin will remain available until the FDA makes a final decision.

Adding to the confusion are two recent contradictory decisions in Europe. The European Union has confirmed its approval of Avastin for metastatic breast cancer (in Europe, Avastin is made by Roche, the Switzerland-based parent company of Genentech). However, the agency responsible for treatment recommendations in Great Britain, called NICE (National Institute for Health and Clinical Excellence) recently rejected Avastin on similar grounds as the FDA.

So what does this all mean for patients and their doctors? What do you think?

Posted March 3, 2011.