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Old 10-02-2013, 04:52 PM   #6
'lizbeth
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Re: Fda has approved perjeta for neoadjuvant use!!

Quote:
FDA approves Perjeta for type of late-stage breast cancer
The U.S. Food and Drug Administration today approved Perjeta (pertuzumab), a new anti-HER2 therapy, to treat patients with HER2-positive late-stage (metastatic) breast cancer.
Intended for patients who have not received prior treatment for metastatic breast cancer with an anti-HER2 therapy or chemotherapy, Perjeta is combined with trastuzumab, another anti-HER2 therapy, and docetaxel, a type of chemotherapy.
@Leah - I think you would qualify. You haven't received any treatment other than for Stage I/II breast cancer, correct?
Knock on wood - that you will never, ever need Perjeta!

I agree with Phil about how piecemeal the approvals are becoming. Why Perjeta only for firstline MBC treatment? This is so frustrating.

I checked Genentech's pipeline for phase III trials for MBC.
I see there is an ongoing trial for Perjeta for 2nd line MBC, and TDM1 for 1st and 3rd line MBC.

The system is the system. I try and post all the clinical trials I come across. The way the system is - we need to work to get full enrollment in the trials as quickly as possible.

With Pcr as an outcome, FastTrack could open up the treatment options for early breast cancer in rapid succession. Hopefully more & more options will enter into the pipeline since the cost of these trials will be dropping significantly. Having income years earlier than typical must be a huge boost to Roche. I hope this helps Genentech move more early breast cancer targeted therapies into the pipeline.

I remember when I was searching for clinical trials in 2007, I felt left out because it seemed that I had to wait until the clinical trial for MBC ended, and then the early breast cancer trial had to start and end. I wondered why the trials couldn't start at the same time. Things have really changed in the last 6 years. This fast track on neoadjuvant studies is quite a shift for the FDA.

So what change would help the stage IV/MBC patients the most? I dislike the system of trying one toxic chemo, then another in the hopes that it will work. Isn't there a company in Greece that can extract CTCs and then run tests (similar to Rational Therapeutics solid tumor cell death end points) to determine which treatments are the most effective?

That is my wish, to use the cancer cells as the test dummy for treatments, and not the MBC patient. The current system truly makes them suffer, and it need to change.

Last edited by 'lizbeth; 10-02-2013 at 04:54 PM.. Reason: clarification
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