[chrisy]

Just to clarify, anyone who has entered the screening process for the EAP by October 31 and who meets the eligibility requirements will be allowed to enroll.

Lifted this excerpt from the post on another forum:

According to a letter that went out today to the
EAP investigators: "Patients already enrolled in this study by this
date will continue to receive T-DM1 until disease progression or
intolerance per study protocol. Patients may be entered into
screening up until October 31st and will be allowed to enroll should they meet all eligibility requirements."
Here are Genentech's stated reasons for this decision:
"This decision is based on the Refuse to File (RTF) letter that
Roche/Genentech received in response to their T-DM1 Biologics
License Application (BLA). The FDA noted that the BLA did not meet the unmet need criteria for accelerated approval because all
available treatment options approved for metastatic breast cancer had not been exhausted in the study population. Based on its preliminary review of the T-DM1 BLA, based primarily on a single arm study in women who had received at least two prior HER2 directed therapies for HER2 positive metastatic breast cancer, the FDA indicated that data from a large, randomized clinical trial will be required for a future submission. The agency also emphasized the need to demonstrate an overall survival improvement.
"Roche/Genentech is currently enrolling patients with HER2 positive
metastatic breast cancer into a clinical study that could fulfill
these requirements. In this study, known as TDM4370g or EMILIA, patients are randomized to receive either a control regimen or T-DM1; there is no cross-over to T-DM1 for patients in the control arm. It is felt that continuing enrollment in T-PAS could interfere with the conduct of this study by potentially providing access to T-DM1 in the control arm, which could unfavorably impact the survival results of EMILIA.
"Roche/Genentech's priority is the conduct of rigorous clinical
trials to obtain full FDA approval of T-DM1 to ultimately provide
T-DM1 access to more women in the future. Enrollment is not being discontinued for safety or efficacy reasons. Roche/Genentech remains committed to the ongoing development program for T-DM1."