AMG 706 will not get FDA approval for GIST

By Norman J. Scherzer

The Life Raft Group has been following the AMG 706 phase II trial for GIST patients for quite some time. We reported in the last issue of our Newsletter our disappointment that we did not see data about AMG 706 at the ASCO (American Society of Clinical Oncology) conference this year.

On July 20, we had a conference call with Dr. Daniel Stepan, lead clinical scientist for Amgen for this study. Amgen has decided that the phase II data (which they will formally present at a professional conference in a few months) will not support a filing with the Food and Drug Administration (FDA) for regulatory approval of this drug for GIST.

We have been assured, however, that any GIST patients currently on AMG 706 who continue to derive benefit from it will continue to receive this drug on an indefinite basis.

Clinical trials for AMG 706 are ongoing for other cancers. It is conceivable that if any of these lead to FDA approval, that GIST patients will be able to have this drug prescribed for them on an off-label basis, although that is entirely up to the prescribing physician.

Finally, Amgen will continue to explore other possible trials for AMG 706 and GIST, such as one for GIST patients who develop resistance to both Gleevec and Sutent and one for pediatric GIST patients.

We agreed that the Life Raft Group and Amgen will continue to work together to seek treatments for GIST patients.