FDA Oncology Announcements

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6 Announcements

FDA approves ivosidenib in combination with azacitidine for newly diagnosed acute myeloid leukemia

Trial: AGILE
Drugs: Tibsovo (ivosidenib) · IDH inhibitor, azacitidine · DNA methyltransferase inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves azacitidine for newly diagnosed juvenile myelomonocytic leukemia

Drug: Vidaza (azacitidine) · DNA methyltransferase inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA grants regular approval to venetoclax in combination for untreated acute myeloid leukemia

Trial: Viale-a
Drugs: VENCLEXTA (venetoclax) · Bcl-2 inhibitor, azacitidine · DNA methyltransferase inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves Onureg (azacitidine tablets) for acute myeloid leukemia

Trial: QUAZAR AML-001
Drug: ONUREG (azacitidine) · DNA methyltransferase inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves oral combination of decitabine and cedazuridine for myelodysplastic syndromes

Drug: INQOVI (decitabine and cedazuridine) · DNA methyltransferase inhibitor
Condition: Myeloid

FDA Approves Decitabine for Injection (Dacogen) to Treat Myelodysplastic Syndromes

Drugs: Dacogen (decitabine) · DNA methyltransferase inhibitor, Dacogen (injection)
Condition: Myeloid