Genentech update on T-DMI early access program

[chrisy]

Genentech has informed us that screening of new patients for enrollment
in T-PAS (T-DM1 Patient Access Study) will be discontinued on
September 6, 2011. Please read this message from Genentech for details:

"This is a difficult decision, but we believe continuing with T-PAS enrollment
would make it difficult to enroll the clinical trials and collect the overall
survival data we believe will be needed for full trastuzumab emtansine (TDM1)
approval in the future. People currently enrolled in T-PAS will
continue to receive trastuzumab emtansine per the protocol.
In addition, Genentech is opening a new Phase III, registrational clinical
trial for people with previously treated HER2-positive mBC (third-line
setting, known as the TH3RESA clinical trial). Screening of new patients in
T-PAS will be discontinued on September 6. This coincides with the
opening of enrollment of the third line trial, TH3RESA, for at least one U.S.
site. TH3RESA will help support FDA approval of trastuzumab emtansine,
as it is designed to confirm if trastuzumab emtansine can improve the
survival of people who have already been treated with other HER2-
targeted medicines. Closing new enrollment in T-PAS was a difficult
decision. However, we believe it is in the best interest of the majority of
people with HER2-positive mBC, as this is necessary to help us conduct
the clinical trials needed to support FDA approval so that access to T-DM1
will not be an issue."