Ivosidenib Approved in Combination With Azacitidine for Treatment of Acute Myeloid Leukemia

The FDA has approved ivosidenib (Tibsovo®, Servier Pharmaceuticals) in combination with azacitidine (Vidaza®, Celgene) for patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) who are at least 75 years old or who have comorbidities preventing them from receiving intensive induction chemotherapy. "Mutant IDH1 catalyzes the production of D-2-hydroxyglutarate, leading to disruption in cellular metabolism and epigenetic regulation and contributing to oncogenesis," wrote Pau Montes...

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Azacitidine Approved for Treatment of Pediatric Patients with Newly Diagnosed Myelomonocytic Leukemia

The FDA has approved azacitidine (Vidaza®, Celgene) for patients with newly diagnosed juvenile myelomonocytic leukemia (JMML), prior to allogeneic hematopoietic stem cell transplantation (HSCT). "JMML is a rare, unique myeloproliferative/myelodysplastic neoplasia of early childhood driven by canonical Ras-pathway mutations in PTPN11, NRAS, KRAS, NF1, or CBL," wrote Charlotte M. Niemeyer, MD, Professor and Medical Director in the Department of Pediatric Hematology and Oncology at Medical Center F...

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Acute Myeloid Leukemia: Oral Azacitidine Maintenance Approved

The FDA has now approved azacitidine tablets (Onureg®, Celgene) for the maintenance treatment of acute myeloid leukemia (AML) after intensive induction chemotherapy in patients who are unable to complete intensive curative therapy and who have achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi). The approval was based on data from the multicenter, double-blind phase 3 QUAZAR trial (NCT01757535), in which 472 patients with AML who achieved CR or CRi w...

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