Genentech’s Avastin Breast Cancer Phase III Back on Track
Posted on December 13, 2009
Filed Under Angiogenesis Modulators
Genentech resumes enrolment to Avastin’s Phase III trial in early-stage HER2-negative breast cancer after FDA re-approval. The trial, E5103 which began enrolment in November 2007, was temporarily suspended last September due to concerns over possible cardio-toxicity profile.
Close to 3,500, of the planned 4,950, patients have been enrolled to date and the study’s data safety monitoring board concluded that the risk-benefit assessment of Avastin in combination with anthracycline, cyclophosphamide and paclitaxel chemotherapy in this trial remained unchanged.
Avastin, an angiogenesis modulator that works by starving tumors of blood is also indicated for lung and colon cancers, has realized over six billion dollar in revenue in 2009 according to BioStrategy internal estimates. The product is marketed outside the US by Hoffmann-La Roche, Genentech’s parent company.
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