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Devimistat Granted Orphan Drug Status for Biliary Cancer The Food and Drug Administration (FDA) has granted Orphan Drug designation to CPI-613 ® (devimistat) for the treatment of biliary cancer. Devimistat targets the mitochondrial tricarboxylic acid cycle selectively in cancer cells and is expected to increase the sensitivity of cancer cells to chemotherapeutic agents. The investigational drug may potentially be used in combination with lower doses of generally toxic drugs with greater efficacy and lower side effects.  The Company is investigating the efficacy and safety of devimistat for the treatment of adults with advanced biliary tract cancer in an ongoing multicenter, randomized phase 1/2 trial (ClinicalTrials.gov Identifier: NCT04203160). Participants will receive either devimistat in combination with standard of care chemotherapy (gemcitabine plus cisplatin) or standard of care chemotherapy alone. 

United statesVaibhav sahaiUniversity of michigan medicineDrug administrationOrphan drugAssociate professorMedical oncologyMichigan medicineஒன்றுபட்டது மாநிலங்களில்வைபவ் சஹாய்பல்கலைக்கழகம் ஆஃப் மிச்சிகன் மருந்துஆர்ஃபந் மருந்துஇணை ப்ரொஃபெஸர்மருத்துவ புற்றுநோயியல்மிச்சிகன் மருந்து