[hutchibk]

UPDATE as of today, 9/15/2011, from Genentech:

Genentech would like to provide an update on the protocol amendment to the T-DM1 patient access study (called T-PAS or TDM4884g) that may allow some patients enrolled in the study to receive T-DM1 closer to their homes. We submitted the proposed amendment to the FDA on August 8, 2011, and have received no questions or concerns to date that would require re-evaluation or revision. As a result, we are proceeding with this amendment. All of the study sites involved have been informed, and the next step is for each site to approve and implement it within their own institutions.

The T-PAS protocol amendment provides T-PAS patients the option to enroll into another, ongoing Genentech/Roche study (called the “extension study” or TDM4529g), which, in essence, doubles the number of sites and locations where T-PAS patients can receive T-DM1.. This option is only available to patients currently enrolled in T-PAS. Transferring to one of the extension study sites is optional and available to patients who have completed at least six cycles (18 weeks) of treatment, are determined stable by their doctor (i.e., not progressing and tolerating T-DM1 without major side effects) and meet other required criteria for the TDM4529g study. Current T-PAS patients interested in receiving T-DM1 at a site closer to home should contact the T-PAS study coordinator at their current site. The study coordinator can help determine if one of the extension study sites is closer and begin the transfer process to the new site. Since the amendment requires IRB approval at each of the original T-PAS and extension study sites, some sites may be able to accommodate the transfer of T-PAS patients more quickly than others.

People not enrolled in T-PAS but still interested in T-DM1 should talk to their doctor about their eligibility for the other T-DM1 studies currently enrolling patients.