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Roche Third-Quarter Pipeline Adjustments Include Advancements, Delays

 
• By Shirley Haley

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.

Roche is accelerating plans to file its novel one-armed antibody onartuzumab (MetMAb/RG3638) in an initial indication of metastatic non-small cell lung cancer by a year thanks to speedy recruitment in the Phase III pivotal trial, Pharmaceuticals Chief Operating Officer Daniel O’Day said Oct. 16 during the firm’s quarterly earnings report, but the Swiss drug giant is also facing delays on other programs.

An initial filing in the mNSCLC indication is now anticipated for 2014. Onartuzumab, which inhibits Met signaling that drives tumor...

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