Good news….

[Sunnydrinking]

cancernetwork.com/view/fda-...

[Pbsoup]

What does fast track mean? How soon will it be available? This is interesting as I was supposed to go on a trial for a similar drug...

[Sunnydrinking in reply to Pbsoup]

Hi

Sorry I don’t have further information but a friend with MBC emailed me the link so I thought I would share it.

Best wishes

Jo xx

[Sunnydrinking]

Not for me either here in the UK but thought it was worth sharing in the hope that it may help some ladies in the forum.

Jo xx

[Hidden]

Hi! I’ve worked in the oncology targeted therapy area for many years. FDA fast track designation is one of a number of programs to get drugs that fulfills an unmet medical need through the FDA approval process more quickly. You can read more about the programs here:

fda.gov/patients/fast-track...

Fast track is an early stage designation that allows more frequent meetings with FDA on drug development issues and faster review of submissions to FDA regarding these issues. It also makes the drug eligible to apply for two other designations breakthrough designation and accelerated approval. These are both very important when the drug approval is filed after completion of registration clinical study (usually Phase 3 but sometimes Phase 2) . These designations reduce the FDA review time for approval from approx 14 months to 6 months.

[Hazelgreen]

Thanks for the interesting reference, Jo. I hadn't realized that there were breast cancers with strong androgen links. This new drug may help some (52%?) of those individuals once it is through all the approval channels.

[love2golfwell]

This sounds very promising, thanks for sharing the information.

[mariootsi]

How do we find out if we are AR positive? I'm not familiar with this? Do I ask my onc to test for this?

[Tolife_18 in reply to mariootsi]

It’s part of pathology report

[Tolife_18]

That you so much for sharing. Fast track program facilitate the collaboration between the pharma company and FDA to facilitate the development and review of the data. This is not necessary means that the drug will be approved. It’s always a subject of data review, but getting this designation is promising.

Hopefully this novel drug will provide the additional effective line of therapy for MBC patients (2nd or 3rd line).

Although this program is FDA specific, the health authorities communication is much better now days. If the ph3 study results are positive, the international submissions will likely follow.

We just need to hang out there!