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Acute Lymphoblastic Leukemia News

FDA Approves Genentech’s Actemra (tocilizumab) for the Treatment of CAR T Cell-Induced Cytokine Release Syndrome

Posted 31 Aug 2017 by Drugs.com

South San Francisco, CA – August 30, 2017 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Actemra® (tocilizumab) intravenous injection for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in patients two years of age and older. CRS, which is caused by an overactive immune response, has been identified as a potentially severe and life-threatening side effect of CAR T cell therapy for certain cancers.1 “Until today, there has never been an FDA-approved treatment to manage severe cytokine release syndrome associated with CAR T cell therapy, which is marked by a rapid onset and can cause life-threatening complications,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Today's ... Read more

Related support groups: Cancer, Leukemia, Actemra, Acute Lymphoblastic Leukemia, Tocilizumab, Cytokine Release Syndrome

First Gene Therapy Kymriah (tisagenlecleucel) Approved in U.S.

Posted 30 Aug 2017 by Drugs.com

WEDNESDAY, Aug. 30, 2017 – The U.S. Food and Drug Administration on Wednesday approved the first gene therapy in the United States, to treat children and young adults with a particularly tough type of leukemia. Kymriah (tisagenlecleucel) is for B-cell acute lymphoblastic leukemia (ALL), the agency said in a news release. "We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer," said FDA Commissioner Dr. Scott Gottlieb. "New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses." Each dose of Kymriah is created using the person's own immune system T-cells. These cells are lab-modified and then reinfused into the patient to target and kill leukemia cells, the FDA explained. ALL is an ... Read more

Related support groups: Cancer, Leukemia, Acute Lymphoblastic Leukemia, Kymriah, Tisagenlecleucel

FDA Approves Kymriah (tisagenlecleucel) CAR-T Gene Therapy for Acute Lymphoblastic Leukemia

Posted 30 Aug 2017 by Drugs.com

August 30, 2017 – The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases. The FDA approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL). “We’re entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer,” said FDA Commissioner Scott Gottlieb, M.D. “New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses. At the FDA, we’re committed to helping expedite the development and review of groundbreaking treatments that have the potential to be li ... Read more

Related support groups: Cancer, Leukemia, Acute Lymphoblastic Leukemia, Kymriah, Tisagenlecleucel

FDA Approves Besponsa (inotuzumab ozogamicin) for Relapsed or Refractory Acute Lymphoblastic Leukemia

Posted 21 Aug 2017 by Drugs.com

August 17, 2017 – The U.S. Food and Drug Administration today approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). “For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment, life expectancy is typically low,” 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. “These patients have few treatments available and today’s approval provides a new, targeted treatment option.” B-cell precursor ALL is a rapidly progressing type of cancer in which the bone marrow makes too many B-cell lymphocytes, an immature type of white blood cell. The National Cancer Institute estimates that approximate ... Read more

Related support groups: Leukemia, Acute Lymphoblastic Leukemia, Besponsa, Inotuzumab Ozogamicin

Besponsa (Inotuzumab Ozogamicin) Approved for Deadly Blood Cancer

Posted 18 Aug 2017 by Drugs.com

THURSDAY, Aug. 17, 2017 – The U.S. Food and Drug Adminstration on Thursday approved the anti-cancer drug Besponsa (inotuzumab ozogamicin) to treat B-cell acute lymphoblastic leukemia (ALL). B-cell ALL is a rapidly growing cancer that occurs when the bone marrow makes too many B-cell lymphocytes, a type of white blood cell. Almost 6,000 people in the United States are likely to be diagnosed with the disease this year, and more than 1,400 are projected to die from it, according to estimates from the U.S. National Cancer Institute. "For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment, life expectancy is typically low," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence, said in an agency news release. "These patients have few treatments available and today's approval provides a new, targeted treatment ... Read more

Related support groups: Cancer, Acute Lymphoblastic Leukemia

FDA Panel OKs What May Soon Be First Gene Therapy Approved in U.S.

Posted 13 Jul 2017 by Drugs.com

WEDNESDAY, July 12, 2017 – A U.S. Food and Drug Administration advisory panel on Wednesday gave unanimous approval to what could soon be the first gene therapy to be marketed in the United States. The treatment, called CTL019, genetically tweaks a patient's own immune system cells into what scientists call "a living drug" to battle a form of acute lymphoblastic leukemia (ALL), The New York Times reported. The FDA's probable acceptance of such a strong recommendation may open a new era of gene-based medicines, which have for so long held only promise against a range of diseases. "When fully commercialized, this [CTL019] therapy will no doubt save the lives of many children and young adults who have had no other effective therapy for relapsed and refractory B-cell acute lymphoblastic leukemia [ALL]," said Dr. John Maris, a pediatric oncologist at The Children's Hospital of Philadelphia. ... Read more

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

FDA Grants Full Approval for Blincyto (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children

Posted 12 Jul 2017 by Drugs.com

THOUSAND OAKS, Calif., July 11, 2017 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) to include overall survival (OS) data from the Phase 3 TOWER study. The approval converts Blincyto's accelerated approval to a full approval. The sBLA approval also included data from the Phase 2 ALCANTARA study supporting the treatment of patients with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The approval expands the indication of Blincyto for the treatment of relapsed or refractory B-cell precursor ALL in adults and children. "For researchers and physicians, overall survival is the primary goal of treatment and the gold standard of outcomes, demonstrating a clear value to patients," ... Read more

Related support groups: Leukemia, Acute Lymphoblastic Leukemia, Blinatumomab, Blincyto

Childhood Cancer Survivors Now Living Healthier Lives

Posted 2 Jun 2017 by Drugs.com

FRIDAY, June 2, 2017 – For people who battled cancer in childhood, the prospects for a long life without cancer recurrence or chronic illness are better than ever, a new study finds. That's largely due to changes in cancer treatment protocols that have meant less toxicity to children and less chance for long-term side effects, researchers said. This is the first "comprehensive" study on the issue, said study author Dr. Todd Gibson, who's with the cancer control department at St. Jude Children's Research Hospital in Memphis, Tenn. As the researchers explained, more children are surviving cancer, but the chemotherapy and radiation they receive as treatment can raise their risk for adult illness years later. So, cancer specialists have worked hard over time to modify treatments to maximize benefits but minimize long-term risks. And it seems to have paid off. In the new study, Gibson's ... Read more

Related support groups: Cancer, Leukemia, Non-Hodgkin's Lymphoma, Acute Lymphoblastic Leukemia, Hodgkin's Lymphoma, Wilms' Tumor, History - Radiation Therapy

FDA Approves Xatmep (methotrexate) Oral Solution

Posted 27 Apr 2017 by Drugs.com

Denver, April 26, 2017 — Silvergate Pharmaceuticals, Inc. leaders in the development and commercialization of innovative and safe medicines for children, today announced that the United States Food and Drug Administration (FDA) approved Xatmep (methotrexate) Oral Solution, the first and only FDA-approved methotrexate oral solution. Xatmep is indicated for the treatment of acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA) in pediatric patients. “Xatmep is an exciting product in that it provides an FDA-approved, ready-to-use oral solution of methotrexate for children without the need for needles, crushing of tablets or compounding into a liquid formulation,” said Frank Segrave, President & CEO, Silvergate Pharmaceuticals, Inc. “As a company, we continue to focus on pediatric medications that are safe, effective, and readily available.” Xatmep (meth ... Read more

Related support groups: Methotrexate, Leukemia, Juvenile Idiopathic Arthritis, Acute Lymphoblastic Leukemia, Xatmep

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, Chronic Lymphocytic Leukemia (CLL), Melanoma, Tasigna, Sprycel, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Imatinib, Dasatinib, 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

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

FDA Approves Blincyto (blinatumomab) For Use In Pediatric Patients With Philadelphia Chromosome-Negative Relapsed Or Refractory B-cell Precursor Acute Lymphoblastic Leukemia

Posted 5 Sep 2016 by Drugs.com

THOUSAND OAKS, Calif., Sept. 1, 2016 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval, and continued approval may be contingent upon verification of clinical benefit in subsequent trials. The approval is based on results from the Phase 1/2 '205, an open-label, multicenter, single-arm trial, which evaluated the efficacy and safety of Blincyto in pediatric patients with relapsed or refractory B-cell precursor ALL. About Study '205 Study '205 evaluated the safety and efficacy of BLINCYTO in a Phase 1/2 ... Read more

Related support groups: Acute Lymphoblastic Leukemia, Blincyto, Blinatumomab

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, Bladder Cancer, Acute Myeloid Leukemia, Breast Cancer, Prevention, Stomach Cancer, Head and Neck Cancer, Acute Lymphoblastic Leukemia, Gastric Cancer, Osteolytic Bone Lesions of Multiple Myeloma, Urinary Tract Cancer, Acute Myeloblastic Leukemia

Certain Cancers Seem Less Likely for Kids of Hispanic Moms Born Outside U.S.

Posted 25 Apr 2016 by Drugs.com

MONDAY, April 25, 2016 – Children of Hispanic mothers who weren't born in the United States may be at lower risk for some types of childhood cancers, a new study suggests. "Incorporating the immigrant experience into studies of childhood cancer may help to inform research on disease [causes], identify vulnerable populations and highlight opportunities for cancer prevention," said Julia Heck, of the University of California, Los Angeles, and her study co-authors. It is important to evaluate childhood cancer risk in the large and growing Hispanic population, the research team said. For the study, the investigators analyzed data from children born in California between 1983 and 2012. The analysis was limited to children of U.S.-born white, U.S.-born Hispanic, or non-U.S.-born Hispanic mothers. Among the children, there were about 13,600 cancer diagnoses before age 6, and more than 15.5 ... Read more

Related support groups: Cancer, Acute Lymphoblastic Leukemia, Wilms' Tumor, Malignant Glioma, Neuroblastoma, Anaplastic Astrocytoma

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methotrexate, Gleevec, Sprycel, mercaptopurine, imatinib, doxorubicin, dasatinib, Adriamycin, Kymriah, view more... Oncaspar, Iclusig, Purinethol, Besponsa, Methotrexate LPF Sodium, tisagenlecleucel, Adriamycin RDF, Marqibo, Adriamycin PFS, Erwinaze, Purixan, Blincyto, Xatmep, Folex PFS, clofarabine, Arranon, Clolar, Vumon, inotuzumab ozogamicin, blinatumomab, ponatinib, vincristine liposomal, asparaginase erwinia chrysanthemi, teniposide, pegaspargase, nelarabine, Trexall