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The FDA's Oncologic Drugs Advisory Committee this week (March 24, 2010) voted 7 to 1 in favor of requiring ChemGenex to submit "a well characterized" in vitro diagnostic to identify patients with T315I mutations prior to the approval of Omapro. "The lack of having a uniform in vitro diagnostic test creates uncertainty about patient selection both in this trial and, more importantly, in a post-approval setting... Most felt that a standardized in vitro diagnostic was needed in order to select the right patients for treatment with omacetaxine."

The FDA is committed to new regulatory requirements that include co-development of companion diagnostics for new therapeutic agents. As we hold the exclusive license for intellectual property around testing for the FLT3 biomarker, a companion diagnostic that identifies FLT3 positive AML patients will be our first companion diagnostic product.

We are currently working with Novartis to develop and commercialize a companion diagnostic test. The test aims to identify FLT3 positive acute myeloid leukemia (AML) patients for specific use in connection with the Novartis development compound, midostaurin (PKC412).  Midostaurin, a targeted small molecule inhibitor of FLT3 tyrosine kinase, is currently in Phase III clinical development for newly diagnosed patients with FLT3 mutated AML who are receiving midostaurin or a placebo in combination with chemotherapy (NCT00651261). FLT3 is mutated in approximately one-third of all AML patients and FLT3 mutations are associated with poor prognosis.

Consistent with the new regulatory landscape, we believe it is important that pharmaceutical companies work hand-in-hand with diagnostic companies to develop the drug with the companion Dx from the outset of clinical trial design.  Clinical investigators and clinical trial sites simply have no capacity to offer a commercial, IP-protected companion diagnostic for FLT3.

Contact us to learn more about how we are building companion Dx around our portfolio of exclusive licensed intellectual property.  To date our portfolio of IP covered targets include the following biomarkers: IGH, IGK, IGL, IGSH, TCRB, TCRG, TCRD, FLT3, NPM1, BCL1/JH (BCL1), and BCL2/JH (BCL2).


Biomarkers are used to tailor treatments for the disease in an individual.

Which Biomarkers should you be tested for if you have been diagnosed with Leukemia, Lymphoma or a Lymphoproliferative disease?

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26 Dec 2011 - A Push to Tie New Drugs to Testing by Andrew Pollack