TCGA Data Leveraged for Developing FDA-Designated Breakthrough Therapy

LOXO-101, a promising new drug developed by Loxo Oncology, received FDA breakthrough therapy designation in July, 2016, for the treatment of metastatic cancers with tropomyosin receptor kinase (TRK) fusions. Using publically available data, including those from The Cancer Genome Atlas (TCGA), Loxo Oncology identified TRK fusions as prime targets for drug development, says Loxo Oncology's Chief Executive Officer, Josh Bilenker, M.D.

"We found that TCGA efforts had contributed to a better understanding of the clinical settings in which TRK fusions occur. Also, TCGA data helped confirm that TRK fusions were typically present in the absence of other known oncogenic drivers," said Dr. Bilenker. "Taken together, these insights helped point the way to clinical settings we might not have considered, while increasing our confidence that TRK fusions were likely to be oncogenic drivers susceptible to therapeutic intervention."

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