FDA Oncology Announcements

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40 Announcements

FDA approves ziftomenib for relapsed or refractory acute myeloid leukemia with a NPM1 mutation

Drug: Komzifti (ziftomenib) · KMT2A inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves revumenib for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation

Trial: AUGMENT-101
Drug: Revuforj (revumenib) · KMT2A inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and pediatric patients with AML or MDS

Drugs: Grafapex (treosulfan) · Alkylating agent, fludarabine · Purine analog
Condition: Myeloid

FDA approves revumenib for relapsed or refractory acute leukemia with a KMT2A translocation

Drug: Revuforj (revumenib) · KMT2A inhibitor
Conditions: LymphoidMyeloidOther hematologic neoplasm

FDA grants accelerated approval to asciminib for newly diagnosed chronic myeloid leukemia

Drug: Scemblix (asciminib) · STAMP inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves imetelstat for low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia

Drug: Rytelo (imetelstat) · Telomerase inhibitor
Conditions: Classical hematologyMyeloid

FDA approves ivosidenib for myelodysplastic syndromes

Drug: Tibsovo (ivosidenib) · IDH inhibitor
Condition: Myeloid

FDA approves bosutinib for pediatric patients with chronic myelogenous leukemia

Drug: Bosulif (bosutinib) · Bcr-Abl inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves quizartinib for newly diagnosed acute myeloid leukemia

Trial: QuANTUM-First
Drug: Vanflyta (quizartinib) · FLT3 inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves olutasidenib for relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation

Drug: Rezlidhia (olutasidenib) · IDH inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves pemigatinib for relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement

Drug: Pemazyre (pemigatinib) · FGFR inhibitor
Conditions: LymphoidMyeloid

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 approves asciminib for Philadelphia chromosome-positive chronic myeloid leukemia

Drug: Scemblix (asciminib) · STAMP inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves avapritinib for advanced systemic mastocytosis

Drug: Ayvakit (avapritinib) · PDGFR inhibitor
Condition: Myeloid

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 gemtuzumab ozogamicin for CD33-positive AML in pediatric patients

Drug: MYLOTARG (gemtuzumab ozogamicin) · Anti-CD33 antibody-drug conjugate
Condition: Myeloid

FDA approves luspatercept-aamt for anemia in adults with MDS

Trial: MEDALIST
Drug: REBLOZYL (luspatercept-aamt) · TGF-beta inhibitor
Conditions: Classical hematologyMyeloid

FDA approves tagraxofusp-erzs for blastic plasmacytoid dendritic cell neoplasm

Drug: ELZONRIS (tagraxofusp-erzs) · IL-3 fused immunotoxin
Condition: Myeloid

FDA approves fedratinib for myelofibrosis

Trial: JAKARTA
Drug: INREBIC (fedratinib) · JAK inhibitor
Condition: Myeloid

FDA approves addition of survival data to gilteritinib label for refractory AML with a FLT3 mutation

Drug: XOSPATA (gilteritinib) · FLT3 inhibitor
Condition: Myeloid

FDA approves ivosidenib as first-line treatment for AML with IDH1 mutation

Drug: TIBSOVO (ivosidenib) · IDH inhibitor
Condition: Myeloid

FDA approves tagraxofusp-erzs for blastic plasmacytoid dendritic cell neoplasm

Drug: ELZONRIS (tagraxofusp-erzs) · IL-3 fused immunotoxin
Condition: Myeloid

FDA approves gilteritinib for relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutatation

Drug: XOSPATA (gilteritinib) · FLT3 inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves glasdegib for AML in adults age 75 or older or who have comorbidities

Drug: DAURISMO (glasdegib) · Hedgehog pathway inhibitor
Condition: Myeloid

FDA approves emapalumab for hemophagocytic lymphohistiocytosis

Drugs: GAMIFANT (emapalumab) · Anti-IFNg antibody, refractory
Conditions: Classical hematologyMyeloid

FDA approves ivosidenib for relapsed or refractory acute myeloid leukemia

Drug: Tibsovo (ivosidenib) · IDH inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves nilotinib for pediatric patients with newly diagnosed or resistant/intolerant Ph+ CML in chronic phase

Trial: DIALOG
Drug: TASIGNA (nilotinib) · Bcr-Abl inhibitor
Condition: Myeloid

Nilotinib label update to include treatment discontinuation recommendations for CML with sustained molecular responses

Trials: ENESTfreedom, ENESTop
Drug: Tasigna (nilotinib) · Bcr-Abl inhibitor
Condition: Myeloid

FDA grants accelerated approval to bosutinib for treatment of newly-diagnosed PH+ CML

Drug: BOSULIF (bosutinib) · Bcr-Abl inhibitor
Condition: Myeloid

FDA approves dasatinib for pediatric patients with CML

Drug: SPRYCEL (dasatinib) · Bcr-Abl inhibitor
Condition: Myeloid

FDA granted approval to vemurafenib for Erdheim-Chester Disease

Drug: ZELBORAF (vemurafenib) · BRAF inhibitor
Condition: Myeloid

FDA Approves Gemtuzumab Ozogamicin for CD33-positive AML

Drugs: Mylotarg (gemtuzumab ozogamicin) · Anti-CD33 antibody-drug conjugate, daunorubicin · Anthracycline, cytarabine · Pyrimidine analog
Condition: Myeloid

FDA approves liposome-encapsulated combination of daunorubicin-cytarabine for adults with some types of poor prognosis AML

Trial: 301
Drug: VYXEOS (daunorubicin and cytarabine) · Anthracycline
Condition: Myeloid

FDA granted regular approval to enasidenib for the treatment of relapsed or refractory AML

Drug: IDHIFA (enasidenib) · IDH inhibitor
Condition: Myeloid

FDA approves imatinib mesylate (Gleevec) to treat pediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia

Drug: Gleevec (imatinib mesylate) · Bcr-Abl inhibitor
Conditions: MyeloidOther hematologic neoplasm

FDA approves dasatinib (Sprycel) for use in the treatment of adults with chronic phase, accelerated phase, or myeloid or lymphoid blast phase chronic myeloid leukemia

Drug: Sprycel (dasatinib) · Bcr-Abl inhibitor
Conditions: MyeloidOther hematologic neoplasm

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

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