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Acute Myeloid Leukemia News

Related terms: Acute Granulocytic Leukemia, Acute Myelogenous Leukemia, ANLL, Cancer, Acute Granulocytic Leukemia, Cancer, Acute Myelogenous Leukemia, Cancer, Acute Myeloid Leukemia, Leukemia, Acute Granulocytic, Leukemia, Acute Myelogenous, Leukemia, Acute Myeloid, AML

FDA Medwatch Alert: FDA Warns That Symptoms of a Serious Condition Affecting the Blood Cells Are Not Being Recognized with the Leukemia Medicine Idhifa (enasidenib)

Posted 13 days ago by Drugs.com

The U.S. Food and Drug Administration (FDA) is warning that signs and symptoms of a life-threatening side effect called differentiation syndrome are not being recognized in patients receiving the acute myeloid leukemia medicine Idhifa (enasidenib). The Idhifa prescribing information and patient Medication Guide already contain a warning about differentiation syndrome. However, we have become ...

FDA Approves Xospata (gilteritinib) for Acute Myeloid Leukemia (AML) with a FLT3 Mutation

Posted 15 days ago by Drugs.com

November 28, 2018 – The U.S. Food and Drug Administration today approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. The FDA also approved an expanded indication for a companion diagnostic, to include use with Xospata. The LeukoStrat CDx FLT3 Mutation ...

Genentech Announces FDA Grants Venclexta Accelerated Approval for People With Newly-Diagnosed Acute Myeloid Leukemia or Those Who Are Ineligible For Intensive Induction Chemotherapy

Posted 17 days ago by Drugs.com

South San Francisco, CA – November 21, 2018 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Venclexta (venetoclax), in combination with a hypomethylating agent (azacitidine or decitabine), or low-dose cytarabine (LDAC), for the treatment of people with newly-diagnosed ...

FDA Approves Daurismo (glasdegib) for Patients with Acute Myeloid Leukemia

Posted 21 Nov 2018 by Drugs.com

November 21, 2018 – The U.S. Food and Drug Administration today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of ...

Why Fewer Blacks and Hispanics Survive Some Childhood Cancers

Posted 22 Aug 2018 by Drugs.com

WEDNESDAY, Aug. 22, 2018 – Poverty is a major reason black and Hispanic children with some types of cancer have lower survival rates than white patients, a new study finds. Researchers examined U.S. government data on nearly 32,000 black, Hispanic and white children who were diagnosed with cancer between 2000 and 2011. For several cancers, whites were much more likely to survive than blacks and ...

Tibsovo Approved for Acute Myeloid Leukemia

Posted 22 Jul 2018 by Drugs.com

FRIDAY, July 20, 2018 – Tibsovo (ivosidenib) tablets have been approved by the U.S. Food and Drug Administration to treat relapsed or refractory acute myeloid leukemia (AML) among people with a defective IDH1 gene. "The use of Tibsovo is associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions," said Dr. Richard Pazdur, ...

FDA Approves Tibsovo (ivosidenib) for Relapsed or Refractory Acute Myeloid Leukemia with an IDH1 Mutation

Posted 20 Jul 2018 by Drugs.com

July 20, 2018 – The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion diagnostic used to detect specific mutations in the IDH1 ...

Are You Sure That's What the Doctor Said About Your Leukemia?

Posted 3 Nov 2017 by Drugs.com

THURSDAY, Nov. 2, 2017 – The stress of a frightening leukemia diagnosis may impede clear doctor-patient communication, a new study suggests. Patients undergoing chemotherapy treatment for acute myeloid leukemia (AML) tend to view their illness and prognosis through a different lens from their doctors, researchers say. Investigators found that patients are inclined to overestimate their risk of ...

FDA Approves Mylotarg (gemtuzumab ozogamicin) for the Treatment of Acute Myeloid Leukemia

Posted 1 Sep 2017 by Drugs.com

September 1, 2017 – The U.S. Food and Drug Administration today approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not ...

FDA OKs Return of Once-Withdrawn Leukemia Drug, Mylotarg

Posted 1 Sep 2017 by Drugs.com

FRIDAY, Sept. 1, 2017 – The U.S. Food and Drug Administration on Friday approved an altered dose of the drug Mylotarg to treat a distinctive type of acute myeloid leukemia – CD33-positive AML. An earlier version of the drug had been withdrawn from the market when health risks started to emerge. Known generically as gemtuzumab ozogamicin, the drug received the go-ahead to treat adults newly ...

FDA Approves Vyxeos (daunorubicin and cytarabine) Liposome for Injection for Certain Types of Poor-Prognosis Acute Myeloid Leukemia

Posted 3 Aug 2017 by Drugs.com

August 3, 2017 – The U.S. Food and Drug Administration today approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos is a fixed-combination of chemotherapy drugs daunorubicin and cytarabine. “This is the first approved treatment specifically for patients w ...

New Combination Treatment, Vyxeos, Approved for Acute Myeloid Leukemia

Posted 3 Aug 2017 by Drugs.com

THURSDAY, Aug. 3, 2017 – The combination chemotherapy drug Vyxeos (daunorubicin and cytarabine) has been approved by the U.S. Food and Drug Administration as the first treatment for certain high-risk types of acute myeloid leukemia (AML). AML is an aggressive blood cancer that forms in the bone marrow. "Vyxeos combines two commonly used chemotherapies into a single formulation that may help some ...

FDA Approves Idhifa (enasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with IDH2 Mutation

Posted 1 Aug 2017 by Drugs.com

August 1, 2017 – The U.S. Food and Drug Administration today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML. “Idhifa is a ...

Idhifa Approved for Some With Acute Myeloid Leukemia

Posted 1 Aug 2017 by Drugs.com

TUESDAY, Aug. 1, 2017 – Idhifa (enasidenib) has been approved by the U.S. Food and Drug Administration to treat adults with a specific genetic mutation that leads to relapsed or refractory acute myeloid leukemia (AML). The mutation in the IDH2 gene can be diagnosed with a newly approved companion diagnostic, the RealTime IDH2 Assay, the agency said in a news release Tuesday. "The use of Idhifa ...

Rydapt Approved for Adults With Acute Myeloid Leukemia

Posted 28 Apr 2017 by Drugs.com

FRIDAY, April 28, 2017 – Rydapt (midostaurin) has been approved by the U.S. Food and Drug Administration, in combination with chemotherapy, to treat adults with acute myeloid leukemia (AML) who have a specific genetic mutation dubbed FLT3. AML, a rapidly spreading cancer that forms in the blood marrow and spikes white blood cells, is projected to be diagnosed in just under 20,000 people, and ...

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cytarabine, glasdegib, Daurismo, Tibsovo, Vyxeos, Idhifa, Venclexta, daunorubicin, gilteritinib, view more... Xospata, ivosidenib, gemtuzumab, vincristine, Oncovin, decitabine, idarubicin, Rydapt, venetoclax, Idamycin, Cytosar, cytarabine liposomal / daunorubicin liposomal, Tarabine PFS, Cytosar-U, Vincasar PFS, Idamycin PFS, midostaurin, Cerubidine, enasidenib, Mylotarg