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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CC-486 Effective for Acute Myeloid Leukemia

The oral hypomethylating agent CC-486, when administered in an escalated dosing schedule (>7 days per 28-day treatment cycle), has been shown to be effective and well tolerated for patients with acute myeloid leukemia (AML) experiencing their first relapse, according to results of a study presented at American Society of Hematology (ASH) Annual Meeting. For the phase 3 international, randomized, double-blind QUAZAR AML-001 trial (NCT01757535), 472 patients with AML were enrolled. To be eligib...

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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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Sorafenib Maintenance Effective at Preventing Relapse in Acute Myeloid Leukemia

Sorafenib maintenance after transplant has shown to be effective in decreasing chance of relapse for patients with acute myeloid leukemia (AML) that have a FLT3 internal tandem duplication (FLT3-ITD) and who are undergoing allogeneic hematopoietic stem-cell transplantation (HSCT), according to recent phase 3 study results published in The Lancet Oncology. A total of 202 patients with FLT3-ITD AML were enrolled. To be eligible, patients had to be aged 18 to 60 years old, currently undergoing allo...

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