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.
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Pertuzumab’s approval came almost a year after FDA and Genentech battled over the future of bevacizumab’s breast cancer claim at an unprecedented public hearing. While both oncologic agents were approved on the basis of a median progression-free survival benefit exceeding five months, the regulatory similarities end there.
Genentech pledges to make new HER2-positive drug Perjeta (pertuzumab) available in the U.S. in two weeks, addresses FDA concerns about production issues and a potential shortage. Firm is already moving forward with plans for integrating Perjeta into its breast cancer portfolio, including combination with antibody-drug conjugate T-DM1.
With the same range of novel product submissions as in 2011, the year ahead could reach an equally healthy tally of new molecular and novel biological entity approvals. But a look at upcoming applications suggests that the makeup of those classes could be very different.