['lizbeth]

The title could have been clearer, but if one reads the post they will realize it is the advisory committee, not the FDA gave Perjeta the thumbs up.

40 days to Halloween, a lot could happen in 40 days - world wide floods, who knows? So excited.

@Lani, you did ask why they didn't respond to your 2 prior posts. We know how you scientific minded individuals love recognition. And I am taking the "first to scoop status back" - I actually posted about this in August and forgot (chemo brain/senior moment?)

This is an enormous shift in medicine and drug approvals if it gets the green light. We are very happy that you are involved enough in keeping up with the latest - to bring it to our attention. "Groundbreaking" - I would totally agree.

I am very excited about the change to pCR, instead of DFS or OS. It gets the industry out of the mindset of sacrificing patients' lives to prove that a medicine works in order to get the FDA stamp of approval.

I see that the stage IVs are struggling with the approval for early stage when not all of them are eligible. I can tell you that I look at Tykerb and Kadcyla and realize that they are not available to early stagers without a clinical trial. And Perjeta is not available to all early stage either. If the tumor size is below 2cm, or if the patient has done surgery first - they will likely not qualify.

Be generous of spirit - the Herceptin, Perjeta and Taxotere combination will likely prevent many from progressing to stage IV, and if carboplatin is added (like the Tryphaena study) another 20 women per 100 could reach pCR.

The more patients this drug is approved for, the more likely it will be approved for other uses, like all stage IV patients.

I eagerly await the news from the FDA, like the rest of you.