Genentech Thinks Pertuzumab Will Escape Avastin Problem, Despite Similarities
Executive Summary
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.
You may also be interested in...
Perjeta, Avastin Breast Cancer Approvals Are A Study In Contrasts
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.
Perjeta Approval Heralds Roche’s Next Wave Of Breast Cancer Drugs
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.
NME Candidates For 2012 Have Modest Ambitions; Standard Reviews And Small Molecules Dominate
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.