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Early Accelerated Approval for Highly Targeted Cancer Drugs
N Engl J Med 2011; 364:1087-1089
We generally support the perspective of the author, who opines, "Given trialist's ability to define patient subgroups with responsive tumors in phase 1 trials, I propose that for diseases lacking therapies that meaningfully extend survival, the FDA should set flexible standards permittiing accelerated approval of new drugs and after phase 1... This strategy requires the early evaluation and validation of a companion biomarker for patient selection...  1. High response rates (>50%), high disease control rates (>75%), and an acceptable toxicity profile in a biomarker-defined population of 75 to 100 subjects should be sufficient for accelerated approval if there's a clear unmet need."

Companion Dx - Targeted Rx Co-development

To ensure timely, cost-effective drug development it is critical that standardized molecular diagnostic tests are used from the outset to properly stratify patients for targeted drug studies. The new regulatory landscape requires companion diagnostic and drug co-development. Consistent with this new regulatory landscape Invivoscribe is on the forefront leading the way.  Biomarker testing done at clinical trial sites, which have no capacity to produce and commercialize a companion diagnostic, simply put drug approval at risk.


Invivoscribe commits substantial resources to understand testing parameters around our biomarkers and changes that occur in testing parameters around our biomarkers in response to drug treatment and therapy. We feel it is a moral imperative and the socially responsible way forward.


Invivoscribe and its subsidiaries have invested and committed substantial resources to ensure we adequately and completely investigate and understand our biomarkers and the changes that occur at the molecular level in these biomarkers in response to drug treatment and therapy. No other company in the Personalized Molecular Diagnostics area has made such a commitment. 

Currently, we are working to develop and validate a companion diagnostic for the FLT3 biomarker and we have commited resources to identify additional mutations in FLT3 and other of our IP protected, clinically-relevant biomarkers.


 



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CE-Marked Assays

Our CE-marked IVD products target biomarkers that have demonstrated clinical utility. These tests are used to identify, stratify and monitor hematologic cancers. Available for sale and use only outside of North America through Invivoscribe Technologies, SARL.

CE-Marked Assays