Lola -Zarnestra - New drug for myelodysplasia

[StephN]

Good morning, Lola -
Well, you have had a night to sleep on your news. I am sure your attitude is even better today!
I did a quick search and came up with some very recent news on Zarnestra. The jargon is more like our normal English, so should be easier to read!
At least this is something to watch and be aware of as there may be a way for you to benefit at some point.


"NDA Submitted for Zarnestra


Jan 24,2005


Today, Johnson & Johnson announced the completion of a NDA submission to the FDA for Zarnestra (tipifarnib), an oral farnesyltransferase inhibitor, for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients 65 years of age and older.

The NDA submission for this indication was based on data from a Phase II study that used measurements of activity and disease responsiveness as endpoints instead of survival. An international Phase III trial, initiated in October 2004, is also being conducted to illustrate the clinical benefit of Zarnestra.

In addition to receiving Fast Track and Orphan Designation, Zarnestra has been entered into the Pilot 1 Program. This program is designed to expedite the rolling NDA concept by allowing the submission of a limited number of "Reviewable Units" of a NDA in advance of the complete application. The FDA is committed to initiating the review of these sections within six months of notification of Pilot 1 status. Products that have been designated Fast Track status and have demonstrated significant therapeutic potential in clinical trials compared to available therapies for the disease or condition are eligible for the Pilot 1 Program. The ultimate goal is to get the drugs through the FDA process and onto the market more quickly.

Zarnestra is also in lower phases of development for multiple other cancer types. "

Another link to a report on the MD Anderson trial from Dec. 2004:
http://www.thedoctorslounge.net/hemalounge...rnestra_aml.htm

There is also a good report I found from a multi-center international trial, so this all looks good for this drug's approval.