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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 responded to initial treatment (refractory). Mylotarg originally received accelerated approval in May 2000 as a stand-alone treatment for older patients with CD33-positive AML who had experienced a relapse. Mylotarg was voluntarily withdrawn from the market after subsequent confirmatory trials failed to verify clinical benefit and demonstrated safety concerns, including a high number of early deaths. Today’s approval includes a lower recommended dose, a different schedule in combination with c ... Read more

Related support groups: Cancer, Leukemia, Acute Myeloid Leukemia, Gemtuzumab, Mylotarg

FDA OKs Return of Once-Withdrawn Leukemia Drug, Mylotarg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 An earlier version of the drug had been withdrawn from the market when health risks started to emerge.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 diagnosed with CD33-positive AML. It also can treat children aged 2 years and older with the disease if they've relapsed or have not responded to initial treatment, the FDA said in a news release. AML is a rapidly progressing cancer. It forms in the bone marrow and elevates the number of white blood cells in the bloodstream. More than 21,000 people will be diagnosed with AML this year in the United States, and about 10,600 will die of it, according to the U.S. National Cancer Institute. This isn't ... Read more

Related support groups: Cancer, Leukemia, Acute Myeloid Leukemia, Acute Promyelocytic Leukemia, Mylotarg

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 with certain types of high-risk AML,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Vyxeos combines two commonly used chemotherapies into a single formulation that may help some patients live longer than if they were to receive the two therapies separately.” AML is a rapidly progressing cancer that forms in the bone marrow and results in an i ... Read more

Related support groups: Cancer, Leukemia, Acute Myeloid Leukemia, Blood Cancer, Cytarabine, Daunorubicin, Vyxeos, Cytarabine/daunorubicin, Cytarabine Liposomal, Daunorubicin Liposomal

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 patients live longer than if they were to receive the two therapies separately," said Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence. In a news release Thursday, the agency said more than 21,000 people will be diagnosed this year with AML, and more than 10,000 will die from it, according to projections from the U.S. National Cancer Institute. The new therapy is sanctioned for high-risk forms of newly-diagnosed therapy-related AML (t-AML) or AML with ... Read more

Related support groups: Leukemia, Acute Myeloid Leukemia, Cytarabine, Daunorubicin, Cytosar-U, Cytosar, Tarabine PFS, Cerubidine

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 targeted therapy that fills an unmet need for patients with relapsed or refractory AML who have an IDH2 mutation,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The use of Idhifa was associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions.” AML is a rapidly progressing c ... Read more

Related support groups: Cancer, Leukemia, Acute Myeloid Leukemia, Blood Cancer, Idhifa, Enasidenib

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 was 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, director of the FDA's Oncology Center of Excellence. AML is a rapidly progressing cancer that begins in the bone marrow and causes an abnormally high number of white blood cells. More than 21,000 people in the United States are projected to be diagnosed with the disease this year, and more than 10,000 are likely to die from it, the U.S. ... Read more

Related support groups: Acute Myeloid Leukemia, Acute Promyelocytic Leukemia

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 more than 10,000 are expected to die of the disease annually, the FDA said. Rydapt is among a class of drugs called kinase inhibitors that are designed to block enzymes that foster cancer cell growth. It was evaluated in a clinical study of more than 700 people who hadn't been treated previously for AML. Common side effects included low white cell count, fever, nausea, headache and muscular/bone pain. A more serious side effect could include lung damage. Women who are pregnant or nursing shouldn't ... Read more

Related support groups: Acute Myeloid Leukemia, Systemic Mastocytosis, Rydapt, Midostaurin

FDA Approves Rydapt (midostaurin) for FLT3-Mutated Acute Myeloid Leukemia and Systemic Mastocytosis

Posted 28 Apr 2017 by Drugs.com

April 28, 2017 – The U.S. Food and Drug Administration today approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy. The drug is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with AML. AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of white blood cells in the bloodstream. The National Cancer Institute estimated that approximately 19,930 people would be diagnosed with AML in 2016 and 10,430 were projected to die of the disease. “Rydapt is the first targeted therapy to treat patients with AML, in combination with chemotherapy,” said Richard Pazdur, M.D., acting director of the Office of Hematology an ... Read more

Related support groups: Leukemia, Acute Myeloid Leukemia, Systemic Mastocytosis, Rydapt, Midostaurin

Gleevec Keeps a Leukemia in Check for More Than a Decade: Study

Posted 9 Mar 2017 by Drugs.com

WEDNESDAY, March 8, 2017 – The cancer drug Gleevec appears to keep chronic myeloid leukemia at bay a decade into treatment – with no signs of additional safety risks, a new study finds. Gleevec – known generically as imatinib – was hailed as a "wonder drug" when it was introduced in 2001 for treating chronic myeloid leukemia (CML). CML is a type of blood cancer that strikes about 5,000 Americans each year, according to the U.S. National Cancer Institute (NCI). Before Gleevec, a CML diagnosis "amounted to a death sentence," the institute said. Now, most cases can be controlled, with either Gleevec or related drugs that have been developed since then. The new findings offer more evidence that the early "hype" around Gleevec was correct, said lead researcher Dr. Andreas Hochhaus, of Jena University Hospital in Germany. Of more than 500 CML patients given Gleevec as their initial ... Read more

Related support groups: Leukemia, Chronic Myelogenous Leukemia (CML), Gleevec, Lung Cancer, Non-Small Cell Lung Cancer, Melanoma, Chronic Lymphocytic Leukemia (CLL), Tasigna, Sprycel, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Dasatinib, Imatinib, Nilotinib, Acute Lymphocytic Leukemia, Acute Myeloblastic Leukemia

Gene Therapy Helps 2 Babies Fight Type of Leukemia

Posted 25 Jan 2017 by Drugs.com

WEDNESDAY, Jan. 25, 2017 – Two infants with an advanced form of leukemia are in remission after treatment with genetically tweaked immune system cells, British researchers report. Both babies had run out of treatment options for their cancer, known as B-cell acute lymphoblastic leukemia, or ALL. But, after treatment with genetically altered T-cells – a type of immune system cell – both went into remission. The babies are now "at home and doing well," said Dr. Waseem Qasim, one of the doctors reporting on the cases. They will still have to be monitored for "some time," said Qasim, a professor of cell and gene therapy at University College London. Small trials are under way, he said, to see if the therapy can be more widely applied. ALL is a cancer of the white blood cells that strikes roughly 6,000 U.S. adults and children each year, according to the American Cancer Society. The ... Read more

Related support groups: Leukemia, Chronic Lymphocytic Leukemia (CLL), Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia, Acute Nonlymphocytic Leukemia, Acute Promyelocytic Leukemia, Acute Myeloblastic Leukemia

Ovarian Cancer Drug Given Fast-Track Approval

Posted 19 Dec 2016 by Drugs.com

MONDAY, Dec. 19, 2016 – The anti-cancer drug Rubraca (rucaparib) has been granted accelerated approval by the U.S. Food and Drug Administration to treat advanced ovarian cancer. The approval is limited to cases where the cancer is caused by specific gene mutations known as "deleterious BRCA." BRCA genes normally repair damaged DNA and are designed to prevent tumor growth, the agency said Monday in a news release. But mutations in these genes could lead to cancer. Rubraca is designed to inhibit a certain enzyme that's produced by a damaged BRCA gene. More than 22,000 women are projected to be diagnosed with ovarian cancer this year, and more than 14,000 are projected to die from the disease, according to U.S. National Cancer Institute estimates cited by the FDA. The FDA simultaneously approved the FoundationFocus CDxBRCA diagnostic screen. This screen detects the presence of deleterious ... Read more

Related support groups: Ovarian Cancer, Acute Myeloid Leukemia

Therapeutic Vaccine Shows 'Game-Changing' Promise Against a Leukemia

Posted 7 Dec 2016 by Drugs.com

WEDNESDAY, Dec. 7, 2016 – An anti-cancer vaccine made from a leukemia patient's own cells can dramatically increase the chance of long-term survival against the deadly disease, a new study indicates. Patients with acute myeloid leukemia – one of the most aggressive blood cancers – must undergo intense chemotherapy to beat back the disease. And then they almost always relapse within a couple of years, explained senior researcher Dr. David Avigan. He is chief of hematological malignancies and director of the Cancer Vaccine Program at the Beth Israel Deaconess Medical Center in Boston. But a handful of leukemia patients have been in remission for nearly five years now, thanks to a new vaccine created from a fusion of leukemia cells and immune cells drawn from their own bodies. The vaccine has produced long-term remission for 70 percent of a small group of 17 vaccinated patients with an ... Read more

Related support groups: Leukemia, Acute Myeloid Leukemia, Diagnosis and Investigation, Acute Promyelocytic Leukemia, Bone Marrow Depression/Low Blood Counts

Experimental Immune Cell Rx Shows Promise for Leukemia

Posted 21 Sep 2016 by Drugs.com

WEDNESDAY, Sept. 21, 2016 – An experimental therapy that revs up the immune system's cancer-fighting ability may help treat some leukemia patients who face a grim prognosis, a small study suggests. The treatment involves infusions of "natural killer" (NK) cells taken from a healthy donor and chemically "trained" to go after tumor cells. Researchers found that of nine patients with acute myeloid leukemia (AML) who received the therapy, four went into complete remission for as long as six months. The findings are preliminary, and the therapy remains experimental, the researchers pointed out. But experts said the results are encouraging considering the outlook these AML patients faced before the trial. Their cancer had either failed to respond to standard chemotherapy or had come back, and they had run out of options. "When you see this kind of response in these patients, it's ... Read more

Related support groups: Leukemia, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Diagnosis and Investigation

Exercise May Cut Risk of 13 Cancers, Study Suggests

Posted 16 May 2016 by Drugs.com

MONDAY, May 16, 2016 – Exercise may significantly reduce your risk for many types of cancer, including some of the most lethal forms of the disease, a large review suggests. Working out for even a couple of hours a week appears to shrink the risk of breast, colon and lung cancer, said researchers who looked at 1.4 million adults. "Those are three of the four major cancers that affect Americans today," said Marilie Gammon. She is a professor of epidemiology with the University of North Carolina at Chapel Hill Gillings School of Public Health. And fitness buffs, take heart – your cancer risk appears to continue to decline as you rack up hours of physical activity, with no apparent upper plateau, said study lead author Steven Moore, an investigator with the U.S. National Cancer Institute. "The more activity, the more the benefit," Moore said. "As people did more, their risk continued to ... Read more

Related support groups: Cancer, Breast Cancer, Leukemia, Lung Cancer, Colorectal Cancer, Non-Small Cell Lung Cancer, Multiple Myeloma, Endometrial Cancer, Small Cell Lung Cancer, Acute Myeloid Leukemia, Bladder Cancer, Stomach Cancer, Breast Cancer, Prevention, Acute Lymphoblastic Leukemia, Head and Neck Cancer, Gastric Cancer, Osteolytic Bone Lesions of Multiple Myeloma, Urinary Tract Cancer, Acute Myeloblastic Leukemia

New Immune Therapy Achieves Complete Remission in Blood Cancer Patients

Posted 16 Feb 2016 by Drugs.com

A new therapy that uses a person's immune system to attack tumors led to complete remission in terminally ill blood cancer patients, according to researchers. In a clinical trial, symptoms vanished in 94 percent of leukemia patients who received the treatment. The response rate was more than 80 percent in patients with other blood cancers, and half achieved total remission, CNBC reported. The results were presented Monday at the annual meeting of the American Association for the Advancement of Science. Detailed data will be published later this year. They therapy involves removing immune system T-cells from patients, loading them with anti-cancer molecules, and placing them back in the body. The altered T-cells then seek and destroy cancer, CNBC reported. The results are unprecedented, according to researcher Stanley Riddell. "In the laboratory and in clinical trials, we are seeing ... Read more

Related support groups: Blood Disorders, Cancer, Hairy Cell Leukemia, Leukemia, Chronic Myelogenous Leukemia (CML), Chronic Lymphocytic Leukemia (CLL), Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Diagnosis and Investigation, Acute Lymphocytic Leukemia, Chronic Eosinophilic Leukemia, Acute Nonlymphocytic Leukemia, Acute Promyelocytic Leukemia, Infection Prophylaxis, Chronic Lymphocytic Leukemia, Meningeal Leukemia, Acute Myeloblastic Leukemia

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vincristine, decitabine, cytarabine, daunorubicin, Rydapt, Oncovin, Cytosar, Cytosar-U, Mylotarg, view more... Idhifa, gemtuzumab, Cerubidine, cytarabine liposomal / daunorubicin liposomal, Idamycin PFS, Vincasar PFS, enasidenib, Tarabine PFS, midostaurin, idarubicin, Idamycin