HER2 Support Group Forums - View Single Post - T-DM1 Compassonate Use

schoonder · 10-22-2009, 06:03 AM

Reading the articles under which the FDA operates I would think that plenty of data have been captured (not all made public) from the T-DM1 phase II trials in 3rd line setting to justify compassionate use of this drug.
Don't believe companies and oncologists are overly eager to take on the additional paperwork to document unapproved drug's performance that is required by such program.

10-22-2009, 06:03 AM	#8
schoonder Senior Member Join Date: Jul 2008 Posts: 186	Re: T-DM1 Compassonate Use Reading the articles under which the FDA operates I would think that plenty of data have been captured (not all made public) from the T-DM1 phase II trials in 3rd line setting to justify compassionate use of this drug. Don't believe companies and oncologists are overly eager to take on the additional paperwork to document unapproved drug's performance that is required by such program.