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furbush87

11/29/14 8:19 PM

#26579 RE: twiz0019 #26576

Yervoy has 5 yr data and has completed a phase 3, Keytruda has 1 year data and has only completed a phase 2. The safety of Keytruda is vastly superior, however the 5 yr survival of yervoy is great. So until Keytruda demonstrates either a phase 3 superior response or a 5 yr survival data.... and of course Keytruda like Opdiva has a considerably lower risk of DEATH from treatment than Yervoy has. But hey, some people would prefer to be in the ICU than face 5min of pain that ImmunoPulse offers....wait I might have that mixed up.
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lasers

11/29/14 8:49 PM

#26580 RE: twiz0019 #26576

Long term time survival after treatment can only be proven with the actual time duration. That being said Yervoy has the historical data whereas Keytruda does not. Even though the short-term Keytruda data was great and Yervoy has certain cons against it, the FDA is not convinced yet that Keytruda short term success will not lead to a long term failure. Therefore Keytruda has to go thru the historicsl long term survival proof before the FDA will upgrade its therapy to primary option.

Having said that, IMO IF the short-term success of the Keytruda Combo with EP-IL-12 results in an increase of at least 10% higher survival short-term than keytruda alone, the FDA will want to make additional allowances in endorsing the therapy and granting BLA Commercial license.