The following details from the 22 March meeting have been...

The following details from the 22 March meeting have been published on the FDA site. I don't think we have seen some of the discussion details before:

"Question to ODAC (VOTE):
A well characterized in vitro diagnostic test is defined as a test for which analytical performance characteristics (e.g., sensitivity, specificity, limit of detection, reproducibility) have been adequately demonstrated and shown to support clinical use. This information has not been provided to the FDA at this time. Two different in vitro tests were used in trial CML-202. The comparability of these tests is unknown. Furthermore, 23 of the 66 patients (including 5 of 11 responders) did not have central laboratory confirmation of the mutation at enrollment at either site.
VOTE: Should a well characterized in vitro diagnostic to identify patients with the T315I mutation be required and reviewed by the FDA and correlated to clinical trial results prior to approval of omacetaxine for the proposed indication?
Vote : Yes=7 No = 1 Abstain = 0

It was noted that the Sponsor should be commended for development of omacetaxine.

Members agreed that the population studied is a population that needs treatments available.

Most members had issues with the assay used being non-standardized that could result in variability between institutions and sites. It was noted by one member that although there may be variability, the results can be interpreted accurately.

One member noted that it would take a prolonged amount of time to develop a standardized assay for the T315I mutation and that there is an immediate need for a new treatment in this population. Some members disagreed noting that the standardized assay could be developed in a shorter period of time.

There was a concern that patients may receive omacetaxine when they could still benefit from other 2nd line therapies. Most felt that a standardized in vitro diagnostic was needed in order to select the right patients for treatment with omacetaxine.

Members agreed that omacetaxine has biologic activity and it was noted that the expanded access route may be a possibility for this product in those that may benefit from treatment."

Regards