T-DM! News

[Joe]

I received this info today in a newsletter:

Clinical findings from the trastuzumab-DM1 (T-DM1) Phase II trial have been accepted for presentation at the San Antonio Breast Cancer Symposium in December
2009. Roche has indicated that, if compelling, these data could enable a T-DM1 marketing application to be filed in 2010.
Regards
Joe

[alicem]

Wonderful news Joe!!

[Lori R]

Joe,
Based on your experience what does this mean in terms of "general availability". Does a marketing application mean that if approved by the FDA that my onc could offer this to me as early as next year?

Any idea on how long the application and approval process takes? (months, years)

I realize you don't have a crystal ball, just wondering from a very high level perspective.

Thank you so much for keeping us updated. I am anxiously awaiting this as a possible option.

Lori

[Joe]

Herceptin results were originally announced at the 1998 ASCO meeting and it was FDA approved in October 1998

Herceptin Adjuvant results were announced in June 2005 and FDA approval was in November 2006

Tykerb results were announced in June of2006, It was FDA appoved in March 2007.

All three drugs were fast tracked by the FDA. Also note that these drugs became available for compassionate use shortly after Genentech and GSK applied for approval.

Regards
Joe

[Lori R]

Joe,
I really appreciate such a prompt and informative response.

This is good news indeed.

Thank you...thank you!!! Lori