publication date: May. 22, 2015

FDA Grants Fast Track To AG-120 in Leukemia 


FDA granted Fast Track designation to AG-120 for the treatment of patients with acute myelogenous leukemia who harbor an isocitrate dehydrogenase-1 (IDH1) mutation.

AG-120 is a first-in-class oral inhibitor of the mutated IDH1 protein being evaluated in two phase I clinical trials, one in hematologic malignancies that recently initiated three expansion cohorts, and one in advanced solid tumors, including glioma.

“We look forward to presenting new data from the ongoing phase I study at the EHA Annual Congress next month and remain on track to initiate a global, registration-enabling phase III study in collaboration with Celgene in AML patients who harbor an IDH1 mutation in the first half of 2016,” said Chris Bowden, chief medical officer of Agios Pharmaceuticals Inc., the drug’s sponsor.


Palmetto GBA issued a draft local coverage determination for the Oncotype DX prostate cancer test developed by Genomic Health Inc. Palmetto is a Medicare Administrative Contractor that assesses molecular diagnostic technologies.

The draft LCD recommends coverage of the Oncotype DX prostate cancer test for qualified Medicare patients throughout the U.S. “to help determine which patients with early-stage, needle biopsy proven prostate cancer, can be conservatively managed rather than treated with definitive surgery or radiation therapy.”

The draft will go through Medicare’s review process, which includes a public comment period, finalization and notification.


Baylor Research Institute and the Translational Genomics Research Institute extended … Continue reading 41-20 FDA Grants Fast Track to AG-120

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