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Event – T-DM1 approval virtually assured, but upside tough to find

Date February 15, 2013

Given how certain investors are of US approval for Roche and ImmunoGen’s T-DM1 “smart bomb” in second-line Her2-positive breast cancer, it is becoming difficult to see how expectations for the product can possibly be exceeded.

The FDA is set to decide on approval by its February 26 action date, and based on the strength of the data from the 989-patient Emilia study a positive outcome is widely assumed. T-DM1 is expected to secure Roche’s Herceptin franchise and underline the value of ImmunoGen’s conjugation technology but, given how lofty expectations have become, pleasant surprises could be in short supply.

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