WASHINGTON, June 26 Roche ROG.VX unit
Genentech is appealing a U.S. proposal to withdraw breast
cancer as an approved use for Avastin, the world's best-selling
cancer drug with $6 billion in annual sales. A hearing on the
appeal takes place Tuesday and Wednesday.
Below is a timeline of key developments on Avastin:
February 2004: Avastin wins its first U.S. Food and Drug
Administration approval, for treating colon cancer, after
showing it extended survival by five months when added to
chemotherapy. The drug was the first medicine to work by
starving tumors of blood, a mechanism known as
October 2006: The FDA clears Avastin for lung cancer.
December 2007: Advisory panel votes 5-4 against
recommending approval of Genentech's application to market
Avastin for breast cancer.
February 2008: FDA rejects panel advice and approves
Avastin for treating breast cancer based on study that showed
the drug delayed cancer growth by 5.5 months. Agency requires
two follow-up studies to confirm effectiveness.
May 2009: Avastin wins U.S. approval for glioblastoma, an
aggressive form of brain cancer.
August 2009: The drug is cleared for treating kidney
November 2009: Genentech submits data to the FDA from
follow-up research in breast cancer. Studies show Avastin
delayed cancer growth by one month to three months, a shorter
period than seen in the earlier study. No studies show Avastin
extends survival of breast cancer patients.
July 2010: FDA advisory panel, in a 12-1 vote, urges the
agency to withdraw approval of Avastin for breast cancer, a use
that generates about $1 billion of the drug's annual sales.
Panelists said Avastin did not offer enough improvement in
breast cancer to justify risks such as gastrointestinal
perforations, bleeding and blood clots.
December 2010: U.S. FDA proposes withdrawing approval of
Avastin for breast cancer. Europe recommends restricting the
drug in breast cancer so it is given with only one type of
chemotherapy. Roche requests a hearing to appeal the U.S.
June 2011: FDA to hold hearing on Genentech's appeal.