FDA Grants Priority Review of Pertuzumab

[KDR]

http://www.modernmedicine.com/modernmedicine/Clinical+News/FDA-grants-priority-review-to-breast-cancer-therap/ArticleStandard/Article/detail/759039?contextCategoryId=40153

Action Date: 8 June 2012

[Rich66]

The pertuzumab application is based on results from the pivotal phase 3 CLEOPATRA study. The study demonstrated a 6.1-month improvement in median progression-free survival (PFS) for people who received a pertuzumab-based regimen (pertuzumab combined with Herceptin and docetaxel chemotherapy) compared to those who received Herceptin and chemotherapy alone (median PFS 18.5 vs 12.4 months). People who received the combination also experienced a 38% reduction in the risk of their disease worsening or death (HR=0.62; P<.0001, according to independent review).

Hopefully they can expedite it beyond solely in combination with docetaxel, one of the harshest chemos.

[ElaineM]

Good news !! Many people are waiting for this drug.

[schoolteacher]

I need this drug.

Amelia

[Adriana Mangus]

I need it too!!!

[yanyan]

Does it mean the approval can be around July? How long does it take for them to make a decision and how long does it take to access patients once is approved. Thanks

[Ellie F]

Great news. Hopefully once approved in the States it will also get approved in the EU and sisters in England may also be able to benefit. i am hoping the bean counters do not stop this happening as was the case with tykerb!
Just to pick up Rich's point I would also be pleased to see it tested against other less toxic combos.
Ellie

[karen z]

Thanks so much for posting.
Good news.