Cancer News

Vaccine for Acute Myeloid Leukemia? (08/14/2019)

A personalized cancer vaccine markedly improved outcomes for patients suffering from acute myeloid leukemia (AML), a potentially lethal blood cancer, in a clinical trial led by investigators at Beth Israel Deaconess Medical Center (BIDMC). The product of a long-term collaboration among investigators at the Cancer Center at BIDMC and Dana-Farber Cancer Institute, the vaccine stimulated... Continue Reading

Gilteritinib Approved for Advanced Acute Myeloid Leukemia (AML) with a FLT3 Mutation (11/29/2018)

The U.S. Food and Drug Administration approved Xospata (gilteritinib) for treatment of adult patients who have recurrent or refractory acute myeloid leukemia (AML) with a FLT3 mutation. About Xospata Xospata has demonstrated inhibitory activity against FLT3 internal tandem duplication (ITD) as well as FLT3 tyrosine kinase domain (TKD), two common types of FLT3 mutations that …

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FDA Approves Venclexta Combination for AML in Adults (11/26/2018)

The Food and Drug Administration granted accelerated approval to Venclexta (venetoclax) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Approval was based on two open-label …

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Tibsovo Approved for Treatment of Relapsed/Refractory Acute Myeloid Leukemia and an IGH1 Mutation (07/23/2018)

Tibsovo® (ivosidenib) has been granted approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA approved test. Data leading to the FDA approval was from a trial that included …

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U.S. FDA Approves Trisenox® Injection for First Line Treatment of Acute Promyelocytic Leukemia (01/31/2018)

CancerConnect News: the U.S. Food and Drug Administration (FDA) has approved the use of Trisenox® (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the (15;17) translocation or PML/RAR-alpha gene expression. The approval was based on a Priority Review by …

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FDA Approves IDHIFA A new Targeted Treatment for Acute Myeloid Leukemia (08/10/2017)

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 Real Time IDH2 Assay, which is used to detect specific mutations in the IDH2 …

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Precision Therapy Enasidenib Effective in Treating Acute Myeloid Leukemia (06/20/2017)

According to early clinical trial results published in the journal Blood, some patients with relapsed or treatment-resistant acute myeloid leukemia may achieve remission with an experimental targeted therapy. AML is the most lethal of the blood cancers, which together are the third leading cause of cancer deaths in the U.S.; AML is responsible for more …

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Venclexta® and Low-doses of Cytarabine Effective in Elderly with Acute Myeloid Leukemia (01/26/2017)

The treatment combination consisting of Venclexta® (venetoclax) plus low-doses of the chemotherapy agent cytarabine appears to be an effective and tolerable treatment regimen for elderly patients with acute myeloid leukemia (AML) who are not eligible for intensive therapy. These results were presented at the 2016 annual meeting of the American Society of Hematology (ASH). AML …

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FDA Priority Review Granted for Midostaurin in Leukemia (11/17/2016)

The United States Food and Drug Administration (FDA) has granted priority review to PKC412 (midostaurin) in the treatment of newly diagnosed acute myeloid leukemia (AML) with the FLT3 mutation, as well as for the treatment of advanced systemic mastocytosis (SM). The diagnostic test to detect the FLT3 mutation has also been accepted for review by … Continue reading "FDA Priority Review Granted for Midostaurin in Leukemia"

Pracinostat Receives Breakthrough Therapy Designation from FDA for Treatment in Combination with Azacitidine of Patients with Newly Diagnosed Acute Myeloid Leukemia (08/09/2016)

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the investigational drug Pracinostat in combination with azacitidine for the treatment of elderly patients with newly diagnosed acute myeloid leukemia (AML). Acute myeloid leukemia (AML) is a cancer of the bone marrow (spongy portion found in the middle of bones) and blood … Continue reading "Pracinostat Receives Breakthrough Therapy Designation from FDA for Treatment in Combination with Azacitidine of Patients with Newly Diagnosed Acute Myeloid Leukemia"