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Posted On: 12/13/2018 10:27:04 AM
Post# of 36542
Keytruda is the reason Jimmy Carter is alive today, after being diagnosed with metastatic melanoma that had spread to the brain. Now he is in complete remission.
AE37 alone showed remarkable strength against triple negative breast cancer in the last trial (89% disease free with AE37 after 55 months, vs 0% disease free in the control group). N is only 21, but .05 p value, which means it is significant even with the low n of 21.
If this upcoming trial with metastatic triple negative bc shows good results early on, I wonder if approval could be given early. That is happening more and more with cancer immunological drugs. And metastatic TN BC is considered incurable at present, with a mean survival time after relapse of something like 9 months. So the FDA has plenty of incentive to accelerate approval using one of their designations such as "breakthough therapy".
AE37 alone showed remarkable strength against triple negative breast cancer in the last trial (89% disease free with AE37 after 55 months, vs 0% disease free in the control group). N is only 21, but .05 p value, which means it is significant even with the low n of 21.
If this upcoming trial with metastatic triple negative bc shows good results early on, I wonder if approval could be given early. That is happening more and more with cancer immunological drugs. And metastatic TN BC is considered incurable at present, with a mean survival time after relapse of something like 9 months. So the FDA has plenty of incentive to accelerate approval using one of their designations such as "breakthough therapy".
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