FDA approves generic decitabine for MDS

Micrograph showing MDS
The U.S. Food and Drug Administration has approved Lupin’s decitabine product, a generic version of Otsuka Pharmaceutical Co. Ltd.’s Dacogen, to treat patients with myelodysplastic syndromes (MDS). Lupin’s decitabine for injection (50 mg, single-dose vial) is approved to treat patients with intermediate-1, intermediate-2, and high-risk MDS. This includes previously treated, untreated, de novo, and secondary MDS of all French-American-British subtypes. [Read Article]

Score can predict thrombosis in ITP

Thrombus
Image by Andre E.X. Brown
New research suggests a scoring system can predict the risk of thrombosis in patients with immune thrombocytopenia (ITP) who are taking anticoagulants. Researchers tested their Thrombosis and Thrombocytopenia (TH2) risk assessment score in a small group of ITP patients on anticoagulants, and the score identified all seven patients who developed thrombosis. The researchers also found that patients’ TH2 scores changed quickly—within a matter of days—which suggests they should be re-evaluated for thrombosis risk frequently. [Read Article]

Health Canada approves two tests for CML patients

CML cells
Image by Difu Wu
Health Canada has approved the use of two tests designed to detect BCR-ABL transcripts in patients with chronic myeloid leukemia (CML)—the MRDx® BCR-ABL Test and the QuantideX qPCR BCR-ABL IS Kit. MolecularMD’s MRDx® BCR-ABL Test is approved as an aid to monitor tyrosine kinase inhibitor (TKI) therapy in Philadelphia chromosome-positive CML patients. This test is also approved to identify CML patients in the chronic phase being treated with nilotinib who, after sustaining a deep molecular response of MR4.5, may be eligible to stop treatment and be monitored for treatment-free remission. [Read Article]