Genentech Thinks Pertuzumab Will Escape Avastin Problem, Despite Similarities

Genentech is confident about a Dec. 6 BLA filing for the monoclonal antibody pertuzumab in HER2 positive metastatic breast cancer with FDA, even though the application is based on a PFS benefit in a single trial.

Genentech Inc.is once again looking for FDA approval for a metastatic breast cancer therapy based on impressive progression-free survival data from a single trial. But the company maintains that the pertuzumab application will not run into the same difficulties as Avastin.

For one thing, the BLA submission is for full approval, not going through the accelerated approval program that led to...

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