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Aug 3, 2009

FDA Gives Roche’s Avastin the Go-Ahead for Metastatic Renal Carcinoma

  • FDA approved the use of Roche’s Avastin in combination with interferon alpha (IFN-alpha) for the treatment of metastatic renal cell carcinoma (RCC). FDA clearance was based on Phase III trial data showing that progression-free survival was nearly twice as long (10.2 months) in previously untreated patients who received Avastin in addition to IFN-alpha compared with patients receiving IFN-alpha alone (5.4 months).

    Avastin is an anti-VEGF antibody, already available in the EU for the treatment of colorectal, breast, non-small-cell lung, and kidney cancers. Approval for the metastatic RCC indication was granted in the EU during 2007.  The drug has been cleared in the U.S. for the treatment of the same advanced cancers as well as also glioblastoma.

    Avastin is currently Roche’s second biggest selling pharmaceutical, behind Rituxan/MabThera). Sales of the drug in 2008 reached CHF 5.2 billion (roughly $7.5 billion), up 37% from 2007. Avastin represented some 15% of all Roche’s pharma sales for that year. Particularly strong growth for Avastin in non-U.S. markets, where 2008 sales were up 67%, was largely due to increased use in metastatic breast cancer, Roche notes.

    At the end of 2008, the global development program for Avastin included some 450 clinical trials.  Commenting on today’s approval, William M Burns, CEO of Roche’s pharmaceuticals division, says, “This underscores our belief in the important clinical benefits that Avastin delivers as we push forward with our ongoing research programs in more than 30 tumor types.”


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