UPDATE 9/16/2011 from Genentech re: TDM1 EAP/TPAS
 

UPDATE as of today, 9/16/2011, 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.

Re: UPDATE 9/16/2011 from Genentech re: TDM1 EAP/TPAS
 

New 176 site international t-dm1 vs physician's choice phase III trial now recruiting.

http://www.clinicaltrials.gov/ct2/sh...1419197&rank=1

Re: UPDATE 9/16/2011 from Genentech re: TDM1 EAP/TPAS
 

"We submitted the proposed amendment to the FDA on August 8, 2011, and have received no questions or concerns"

Egad..going forward based on lack of response..you'd think they'd get a green or red light.

Re: UPDATE 9/16/2011 from Genentech re: TDM1 EAP/TPAS
 

Is FDA to blame for not responding or does this imply that Genentech's regulatory department really doesn't understand the requirements and is seeking government intervention were none is called for?
FDA's refusal to even look at phase II data that Genentech hoped to get an early T-DM1 approval for clearly shows a major disconnect between these organizations. What terrible way to conduct business.

Re: UPDATE 9/16/2011 from Genentech re: TDM1 EAP/TPAS
 

I think that they are empowered to move forward if they don't receive concerns for revision or an all out red light from the FDA within a stated time period after submission...

This is just a submission to move traveling patients closer to their home clinics, which TDM1 trials and clinics can be considered for rolling these patients in, and how they intend to account for the TPAS patient's data.