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FDA Approves New Treatment for Leukemia

06:06 EDT 2 Aug 2017 | Genetic Engineering News

Celgene and Agios Pharmaceuticals have won FDA approval for an acute myeloid leukemia (AML) treatment intended for patients with specific mutations of the isocitrate dehydrogenase 2 (IDH2) gene. Idhifa ® (enasidenib) is an IDH2 inhibitor approved yesterday as a treatment for adults with relapsed or refractory AML who show IDH2 mutations in blood or bone marrow samples following use of a companion diagnostic, Abbott Laboratories’ RealTime IDH2 Assay. While Celgene received the formal FDA approval, the biotech giant has worked with Agios over seven years to develop Idhifa, previously known as AG-221 and CC-90007. Idhifa is the first development candidate developed through the first of several collaborations between the companies, launched in April 2010. Celgene offered $130 million upfront, including an equity investment, for rights to co-develop an unspecified number of drugs discovered through Agios’ cancer metabolism research platform, based on the concept of “starving” ...

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