[Joe]

Copied from another BC Board and confirmed with Genentech

I just got off the phone this afternoon with the Genentech advocacy relations person I deal with, and T-DM1 was the #1 topic of conversation. As I'm sure you know, they presented some pretty impressive data in San Antonio on how well
this drug works in "refractory" late-stage HER2+ MBC patients who have been "extensive pretreated." The poster for this Phase II study can be found here: http://www.posters2view.com/sabcs09/viewp.php?nu=5090
It's on the basis of this study that Roche (which now owns Genentech) is applying for an accelerated approval for T-DM1 in late-stage metastatic breast cancer, where these same other treatments have
failed. Accelerated approval is a provisional authorization by to market a drug that permits access to new therapies (but not advertizing) on the basis of so-called "surrogate endpoints" that can be said to reasonably predict clinical benefit. Accelerated approval
requires subsequent confirmatory randomized controlled trials to convert to full approval. That trial that is currently enrolling patients is the EMELIA trial
http://clinicaltrials.gov/ct2/show/NCT00829166?term=t-dm1&rank=4
which compares T-DM1 with lapatinib (Tykerb) + capecitabine (Xeloda).
If FDA approves T-DM1, the drug may be on the market as early as the end of 2010 (although of course things can go awry). In the meantime, Genentech plans to initiate an expanded access (compassionate use) study to serve as a "bridge" for patients who meet the very strict criteria of having had multiple prior treatment
failures as described on the poster as "Patients with HER2+
Metastatic Breast Cancer who were Previously Treated with an Anthracycline, a Taxane, Capecitabine, Lapatinib, and Trastuzumab." At this point, I don't know whether a requirement wil be that brain mets be stable.
There are details to be worked out, treatment sites to be chosen, etc. But their best guess for time of availability will be sometime in May