Lessons from Avastin

In the third-quarter of 2010 (3Q10), a US regulatory advisory committee voted twelve to one to rescind Roche/Genentech’s Avastin’s conditional approval on the basis of (tumor) progression – free survival (PFS) to treat advanced breast cancer. This decision followed a review of trial data in which Avastin, in combination with chemotherapy, reliably did not increase overall survival (OS), as compared to chemotherapy only, above chance levels across four new and old studies (bloomberg.com, 7/21/10; pharmalot.com, 2/24/11). In terms of safety, based on clinical trial data across solid tumor types (N = 10,217 patients, randomized in 16 trials), fatal adverse events with Avastin occurred at a rate that was nearly 1% greater absolutely (2.5% vs 1.7%), as compared to chemotherapy alone (Ranpura, etal., 2011). The most common causes of fatal adverse events were hemorrhage (23.5%), neutropenia (12.2%), and gastrointestinal tract perforation (7.1%), and were observed independent of tumor type. On this basis, presumably, the US regulators questioned the efficacy : safety of the biologic in the population with advanced breast cancer.

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