CHEMGENEX, THE FDA AND TOUGH QUESTIONS
March 12th 2010 01:58
Biotech Daily
Tuesday February 9, 2010
Daily news on ASX-listed biotechnology companies
Tuesday February 9, 2010
Daily news on ASX-listed biotechnology companies
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MARC SINATRA’S BIOGUIDE BRIEF: CHEMGENEX
The US Food and Drug Administration has released its briefing document for the oncologic drugs advisory committee meeting to review the data on Chemgenex’s Omapro for chronic myeloid leukaemia in patients with the T315I mutation.
In short, after reviewing Chemgenex’s data and the medical data collected from the patients on whom it is based, the FDA has produced its own data set.
Most notably, it believes that only six of 40 (15%) patients in the chronic stage of the disease, rather than the 10 of 40 (25%) collated by Chemgenex, demonstrated a major cytogenetic response to treatment with Omapro.
The FDA also did not consider the two of 10 (20%) blast phase patients that responded to treatment according to Chemgenex, to be true responders, leaving Omapro with none of 10 on this count and it appears that Chemgenex’s data is much more sparse than hoped.
While not the death of Omapro by any means, it does look like more data will need to be collected. Omapro's saving grace may be that ODAC isn't bound by the FDA's slicing and dicing of the data.
The most impressive piece of data in the Omapro package is that 85 percent of the 40 chronic phase patients studied exhibited a complete haematologic response.
The FDA hasn't considered this point because they don't view haematological responses as a suitable end-point for chronic phase patients.
The medical literature does, however, and I believe ODAC's recommendation will hinge on this point. While the FDA is not bound by ODAC's recommendation, positive or negative, it does generally follow it.
Despite the FDA's aggressive stance toward Omapro's NDA, I still think they will approve it, most likely with some hefty post-approval surveillance requirements.
Marc Sinatra
Analyst
Analyst
Marc Sinatra and Biotech Daily editor David Langsam both hold Chemgenex stock.
Email Marc here
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