['lizbeth]

Laurie,

Well I didn't want everyone to be quite that generous, as in not receiving Perjeta for years. But this potential FDA approval could save many early stagers from progressing to stage IV, and as Lani pointed out - it is quite novel, a paradigm shift, to base an approval on pCR. Some mother who is diagnosed in 3 months or 6 months might not needlessly suffer because of this approval. With this blessing of receiving Perjeta early she could become another one of the long time survivors who never had a recurrence.


I've been mulling on this issue. I thought Herceptin was approved for all stage IV, and then years later the earlier stages.

Now I see this piecemeal approval process where you can get this drug if you are first line, that one second line and so on . . .
and again the neoadjuvant Perjeta seems quite limited, only 2cm or larger. So if you are lucky enough to have early detection you are not lucky enough to receive Perjeta?

I was looking at the Perjeta trials for stage IV to share. I found a promising one internationally, but for the US - am I missing something?

And to be honest, I don't understand the compassionate use policies. It seems to me that I see so many postings that yet another stage IV cancer patient was denied a drug that is in clinical study. Why? Why do we as a society allow people to die when a possible treatment exist and a person is willing to try it? Cost, legalites, risk of delay treatment approval?

It all sucks right now, especially with Mandamoo struggling.

But if Perjeta gets fast-tracked based on pCR - it could really change the fast-track approval process. Could you imagine a stage IV trial based on pCR and not OS? This could be the start of what you wish for, faster FDA approvals of medicine for those who are in critical need.