Expanded access is another name for "Compassionate Use"
Christine and I have been meeting with Genentech since last June's ASCO meeting lobbying this issue.
Unfortunately because of liability issues, Genentech could not release the drug for this purpoise until they could provide data to the FDA based on the phase II study.
Here is a copy of their press release from the Symposium:
T-DM1 Press Release
I think this excerpt from ther release sums it all up:
As assessed by independent review, T-DM1 shrank the tumors (also known as objective response) in 33 percent of women with advanced (metastatic) HER2-positive breast cancer that had worsened following previous treatment. Women in the study had already received an average of seven drugs for metastatic disease, including chemotherapy, trastuzumab and lapatinib, prior to receiving T-DM1.
Warmest Regards
Joe