Will the antacid work if I stick it up my butt?
Seriously now. If I am not mistaken, Genentech has license to try both IMGN (not sure) and SGEN (sure) ADCs. For each target, Genentech may be testing both ADCs on the antibodies to find out which combo will work better. In that sense, SGEN technology is in direct competition with IMGN's. I won't be surprised that for some protein targets, specific antibodies, and/or cancer types, one ADC will work better than the other.
Pfizer's Mylotarg may have had lower toxicity and better efficacy if the antibody was linked with either IMGN or SGEN ADCs. Same target, same antibody, same tumor, different ADC.
Again i don't follow your logic. As the previous poster pointed out, not even the same target. How can a breast cancer adc be in competition with a meyloma adc. Also both are already partnered. Its like saying dm1is in competition with dm4.
or in layman terms would you take an antacid for a hemmeroid?
I disagree. This article shows how SGEN was smarter than IMGN:
"Last month, the FDA refused to even consider a breast cancer drug that combined Roche’s Herceptin with a chemotherapy using a linking technology developed by Immunogen, causing shares of Immunogen to plummet.
Seattle Genetics says it expects to avoid Immunogen’s fate, because it has an agreement called a Special Protocol Assessment with the FDA. “The FDA has agreed that our pivotal trial design meets requirements for accelerated approval, including agreement that our pivotal trial population represents an unmet medical need,” a spokeswoman writes. She adds that the company believes the FDA’s decision on the Immunogen drug “relates to the evolving landscape and many therapies approved for the treatment of metastatic breast cancer, rather than any more broadly applicable principles.”
-Long IMGN, wish I was long SGEN. -Biobottom
<"Last month, the FDA refused to even consider a breast cancer drug that combined Roche’s Herceptin with a chemotherapy using a linking technology developed by Immunogen, causing shares of Immunogen to plummet.>
It wasnt the drug they refused to consider, it was the application, big difference.
really, how were they "smarter" Did IMGN design the trials, NO, that was Roche I believe. The only stupid thing IMGN did was buying into the idea FDA would approve a drug based on a single arm 100 pt trial because the patient population needs therapy. Well, it turns out FDA is run my corrupt morons, not a new finding. OREX and potentially SGEN investors will learn about the FDA problems in the near future. Good luck!
It's further evidence for ADC's (I think) I don't follow SGEN all that closely. I am curious to know why SGEN could file based on a trial that was designed similarly to TDM1's single arm trial with roughly the same number of patients. If SGEN has hedge funs shorts they will pay someone at the FDA to slow them down like the did with the weight loss drugs and likely IMGN. Bunch of crooks.
Bio, the fact that the T-DM1 trial was a small single arm trial had nothing to do with the RTF. The FDA decision would have been the same for a large double blinded trial.
It all has to do with the endpoint and the Accelerate Approval rules.
AA is used when the endpoint is not clinically significant, but the FDA believes it likely correlates to a real benefit. This was the case in both trials. But AA can only be used when the patient group does not have alternatives. The FDA is claiming that T-DM1 can not be AA'ed because the patients in the study still had options available, while those in the SGN-35 study did not.
No argument that the FDA seamed whacko on T-DM1, especially RTF'ing it which is very where outside of scam biotechs.
SGEN skates by on this one.
Its simple,fda already told sgen, that they would accept the trial for early bla. The difference between 35 and tdm1is the targeted patients have far less options with meyloma. We know the fda doesn't see that need with tdm1:
Simple... SGEN does not have a partner that recently embarassed the FDA by talking them into an early approval of a drug that didn't work... the ole' saying gets verified once again... paybacks are a MF'er...