HER2 Support Group Forums - View Single Post - From the NEJM: The FDA's New “Breakthrough Therapy” Designation

'lizbeth · 11-19-2013, 10:50 AM

I am looking at paclociclib and I see the Phase III NCT01740427 trial just started February 2013.

Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure):
Outcome Measures: Progression-Free Survival (PFS) [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.

Completion date of the study is March 2016.

My question for you clinical trial savy people - how does the Breakthrough therapy affect the timeline. Will the approval likely be 4 months from the completion of the primary outcome? I calculate June or July 2015.

Yes, I'm a bit mystified about Perjeta. The approvals are becoming specific and restrictive. I do see this posting about the first line treatment of MBC:

http://www.perjeta.com/hcp/clinical

I don't understand why it is not available to all who have metastatic cancer.

11-19-2013, 10:50 AM	#3
'lizbeth Senior Member Join Date: Apr 2008 Location: Sunny San Diego Posts: 2,214	Re: From the NEJM: The FDA's New “Breakthrough Therapy” Designation I am looking at paclociclib and I see the Phase III NCT01740427 trial just started February 2013. Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure): Outcome Measures: Progression-Free Survival (PFS) [ Time Frame: Baseline up to 2.5 years ] [ Designated as safety issue: No ]Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Completion date of the study is March 2016. My question for you clinical trial savy people - how does the Breakthrough therapy affect the timeline. Will the approval likely be 4 months from the completion of the primary outcome? I calculate June or July 2015. Yes, I'm a bit mystified about Perjeta. The approvals are becoming specific and restrictive. I do see this posting about the first line treatment of MBC: http://www.perjeta.com/hcp/clinical I don't understand why it is not available to all who have metastatic cancer.