wins Orphan drug status 1/09 with expected submission of rolling NDA in mid-2009; NDA submitted 9/09 and accepted 11/09; EU accepts MAA 11/09; FDA advisory board to review 2/10/2010, but rescheduled due to extreme weather (2/10); FDA released a briefing document ahead of the review questioning the low response rate; FDA advisory board voted 7-1, requiring a validated test to identify the T315I mutation should be reviewed by the FDA prior to approval of Omapro (3/10); Complete response letter received 4/10, with no new clinical trial needed, concerns raised similar to those of Advisory board; met with FDA and agreed to combine data from its two pivotal studies and submit NDA for CML patients who have failed prior treatment 2 or more TKIs, regardless of their mutation status (7/10)
Brand Omapro Generic omacetaxine mepesuccinate
Company name ChemGenex Pharmaceuticals Product type Speciality
Therapeutic category Antineoplastics Key uses chronic myelogenous leukemia (CML)
Other Uses N/A Drug Class induces apoptosis by inhibition of protein synthesis, particularly Mcl-1
Dosage From SC Expected Approval 2011-Q1
FDA Filing 7/08 Last Update date July 26,2010
Link to news release
Link to clinicaltrials.gov
Link to press releases