ODAC meeting with ChemGenex expected on March 22 (ASX:CXS) (Nasdaq:CXSPY)

OMAPRO™ (omacetaxine mepesuccinate) is a drug developed and manufactured by ChemGenex Pharmaceuticals Limited (ASX: CXS). The drug is used to treat patients who are suffering from CML (chronic myeloid leukemia) and who, as a result of previous treatment from imatinib, have experienced Bcr-Abl T315I mutation. The company wanted to commercialize the drug in the United States of America. For this purpose, it submitted a new drug application (NDA) to the country’s toughest regulator – the Food and Drug Administration (FDA). Currently, the Oncologic Drugs Advisory Committee (ODAC) of the FDA is reviewing the NDA. The committee is planning to hold a meeting with ChemGenex on March 22.

The ODAC is an independent committee whose members or experts are unbiased and not influenced by any pharmaceutical company. When an NDA is submitted to the FDA, the ODAC analyze the information – regarding the safety and the efficiency of the drug – and send its feedback to the FDA. This feedback is one of the tools that the FDA uses to decide whether to approve the NDA or not. However, there have been many cases in which the FDA approved a particular NDA, even if the feedback from the ODAC regarding the application had been negative.

On March 22 – that is, on the ODAC meeting – the experts would check the information related to the efficiency and the safety of the drug from various sources – the applicant or sponsor (that is, ChemGenex), the staff from the FDA who have already conducted a review on the NDA, and other third party experts who specialize in oncology.

Greg Collier, PhD, who is the Managing Director as well as the Chief Executive Officer of ChemGenex, said:

“The ODAC meeting is a significant milestone in the review process for OMAPRO, our team is well-prepared and we are looking forward to presenting to the ODAC panel.”