Final Perjeta Overall Survival Data Delayed By Its Efficacy
This article was originally published in Pharmaceutical Approvals Monthly
Overall survival results from the CLEOPATRA study, which produced the progression-free survival data that supported FDA’s decision in June to give Perjeta full approval for use in combination with Herceptin and chemotherapy, were reported at the San Antonio Breast Cancer Symposium Dec. 7.
You may also be interested in...
Roche adjusted regulatory expectations for its pipeline during a third-quarter earnings call Oct. 16, moving up filing plans for onartuzumab (MetMAb) in metastatic non-small cell lung cancer to 2014 and pushing back an ocrelizumab filing in multiple sclerosis to 2015, both based on trial enrollment rates.
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.
Commercialization of the fixed-dose combo buys lifecycle management for Forest and should support future drug development for partner Adamas, the originator of the technology behind the combination.