HER2 Support Group Forums - View Single Post - Our T DM-1 Story Part 2 Tonight

Rolepaul · 06-05-2012, 10:33 AM

Great drug that took a long time to get to market. The linkage of the mayastine to the Herceptin was considered unstable by some, but the final method of attachment was known in the mid 1980s for use in diagnostic kits. I think there were patent issues with the linkage that ran out and let Roche/Genentech use it. However the problems with the linkers scared the reviewers. In addition, there was some attitude issues in the previous Genentech presentation that did not play well with the reviewers last time around. The transcripts of the hearing are public record and are worth reading. I might agree with the review board having an attitude, but so did the Genentech presentation team. The frustrating part is patients were the ones hurt by this. Time for pompous attitudes by government and industry to be put to the side for the good of patients.

By the way, Brain/Spine Mets will be the next issue with Her2 patients. I hope that we have found a solution to this issue which might affect 20-35% of the HER2+ patient family.

06-05-2012, 10:33 AM	#8
Rolepaul Senior Member Join Date: Jan 2012 Location: Boulder Colorado as of January 2013 Posts: 391	Re: Our T DM-1 Story Part 2 Tonight Great drug that took a long time to get to market. The linkage of the mayastine to the Herceptin was considered unstable by some, but the final method of attachment was known in the mid 1980s for use in diagnostic kits. I think there were patent issues with the linkage that ran out and let Roche/Genentech use it. However the problems with the linkers scared the reviewers. In addition, there was some attitude issues in the previous Genentech presentation that did not play well with the reviewers last time around. The transcripts of the hearing are public record and are worth reading. I might agree with the review board having an attitude, but so did the Genentech presentation team. The frustrating part is patients were the ones hurt by this. Time for pompous attitudes by government and industry to be put to the side for the good of patients. By the way, Brain/Spine Mets will be the next issue with Her2 patients. I hope that we have found a solution to this issue which might affect 20-35% of the HER2+ patient family.