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22 Mar 2011

Roche Tees up New App on Promising Ph2 Cancer Drug

The prospect of using Phase II data from a single-arm study of 104 patients to support a regulatory filing in the U.S. could prove problematic, though, considering Roche's experience with the highly promising 'armed antibody' T-DM1.

Lexington, MA-based Curis announced that its partners at Roche/Genentech have wrapped a positive mid-stage trial for an experimental new treatment for advanced basal cell carcinoma. And the biotech added that Roche has planned to file at least one marketing application for the hedgehog pathway inhibitor, GDC-0449, later this year on the "pivotal" data.

 

Genentech is holding on to the data from the study for a scientific meeting to be announced, but Curis touted the fact that the therapy hit its p

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