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

Posted 12 days ago 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 13 days ago 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

FDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and Lymphomas

Posted 19 days ago by Drugs.com

June 29, 2017 – The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN). “This represents a major step forward for the hematology-oncology community,” said Alberto Gutierrez, Ph.D., Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Laboratories and health care professionals now have access to an FDA-validated test that provides consistent results to aid in the diagnoses of these serious cancers.” According to the National Cancer Institute, leukemia is a cancer of the blood that originates in immatu ... Read more

Related support groups: Leukemia, Lymphoma, Diagnosis and Investigation

FDA Approves Rituxan Hycela (rituximab and hyaluronidase human) for Subcutaneous Injection in Certain Blood Cancers

Posted 26 Jun 2017 by Drugs.com

South San Francisco, CA – June 22, 2017 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved Rituxan Hycela (rituximab and hyaluronidase human) for subcutaneous (under the skin) injection for the treatment of adults with the following blood cancers: previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), and previously untreated and previously treated chronic lymphocytic leukemia (CLL). This new treatment includes the same monoclonal antibody as intravenous Rituxan® (rituximab) in combination with hyaluronidase human, an enzyme that helps to deliver rituximab under the skin. “With today’s approval of Rituxan Hycela, people with three of the most common blood cancers now have a new treatment option which provides efficacy c ... Read more

Related support groups: Cancer, Leukemia, Rituxan, Lymphoma, Rituximab, Chronic Lymphocytic Leukemia (CLL), Follicular Lymphoma, Diffuse Large B-Cell Lymphoma, Rituxan Hycela, Hyaluronidase/rituximab

Childhood Chemo May Have Lasting Effects on Memory

Posted 20 Jun 2017 by Drugs.com

TUESDAY, June 20, 2017 – Childhood cancer survivors who had chemotherapy may have certain types of thinking and memory problems as young adults, a small study suggests. Belgian researchers assessed 31 young adults who had undergone chemotherapy. They were at an average age of slightly over 6 when they had the treatment. The researchers compared them with a control group of young adults who hadn't received chemotherapy. Both groups had similar scores on tests of long-term memory and ability to concentrate. Those are skills that developed before the cancer survivors underwent chemotherapy, the researchers said. But compared to the control group, the cancer survivors had poorer thinking flexibility and short-term memory. These skills develop at a later age, the researchers explained. "Tests that require quick switching between tasks or remembering new information for a short amount of ... Read more

Related support groups: Cancer, Methotrexate, Leukemia, Fluorouracil, Xeloda, Hydroxyurea, Mercaptopurine, Hydrea, Carboplatin, Cisplatin, Cytoxan, Cyclophosphamide, Capecitabine, Dacogen, Temodar, Bendamustine, Oxaliplatin, Gemcitabine, Treanda, Gemzar

Cancer Drug, Dasatinib, Helps Some Kids With Rare Type of Leukemia

Posted 5 Jun 2017 by Drugs.com

MONDAY, June 5, 2017 – The cancer drug dasatinib shows promise in treating children with chronic myeloid leukemia (CML) caused by the gene BCR-ABL, also known as the Philadelphia chromosome, researchers report. "Despite the fact that there is a common molecular driver – BCR-ABL – for this disease in adults and in children, the manifestation in children is different. Pediatric patients tend to have more aggressive disease," said study senior author Dr. Lia Gore. She is co-director of the University of Colorado Cancer Center's Hematological Malignancies Program. "What we saw from the patients we enrolled at Children's Hospital Colorado and around the world was that patients had great disease control, minimal toxicities and were really able to move into normal activities, a normal daily life," Gore said in a university news release. "One of our long-term patients is in college now and ... Read more

Related support groups: Leukemia, Chronic Myelogenous Leukemia (CML), Sprycel, Dasatinib

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, Hodgkin's Lymphoma, Acute Lymphoblastic Leukemia, Wilms' Tumor, History - Radiation Therapy

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

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

Cancer Risk Rises After Childhood Organ Transplant: Study

Posted 26 Apr 2017 by Drugs.com

WEDNESDAY, April 26, 2017 – Children given an organ transplant have a substantially higher risk of developing cancer – in some cases up to 200 times higher – than the general population, a new study finds. But the individual risk of any one child getting cancer still remains very small, the study authors stressed. Overall, the U.S. National Cancer Institute (NCI) study found that the risk for cancer among children who received transplants was 19 times higher than in the general population. Non-Hodgkin's lymphoma was the cancer with a 200 times higher risk. Seventy-one percent of those who developed cancer after a pediatric organ transplant had non-Hodgkin's lymphoma, the study findings showed. "We knew going into the study that the risk of lymphoma would be very high," explained Dr. Eric Engels, the study's senior investigator. "That's been seen in much smaller studies, and it's been ... Read more

Related support groups: Cancer, Leukemia, Renal Transplant, Non-Hodgkin's Lymphoma, Organ Transplant - Rejection Prophylaxis, Viral Infection, Organ Transplant, Kidney Transplant, Organ Transplant - Rejection Reversal, Rejection Prophylaxis, Rejection Reversal

Black Americans' Cancer Rates Differ by Birthplace

Posted 13 Apr 2017 by Drugs.com

THURSDAY, April 13, 2017 – Cancer rates differ between African- and U.S.-born black Americans, a new study finds. "Typically, cancer occurrence among blacks in the United States is presented as one homogenous group, with no breakdown by country or region of birth," said study co-author Dr. Ahmedin Jemal, an American Cancer Society epidemiologist. "Our study shows that approach masks important potential differences that may be key to guiding cancer prevention programs for African-born black immigrants," Jemal added. The researchers analyzed 2000-2012 U.S. data to compare rates of the top 15 cancers in African-born blacks to U.S.-born blacks. Blacks born in sub-Sahara Africa had much higher rates of infection-related cancers (liver, stomach and Kaposi sarcoma) than U.S.-born blacks. They also had higher rates of blood cancers (leukemia and non-Hodgkin lymphoma), prostate cancer and ... Read more

Related support groups: Cancer, Prostate Cancer, Leukemia, Thyroid Cancer, Kaposi's Sarcoma

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

Childhood Cancer Survivors Living Longer

Posted 28 Feb 2017 by Drugs.com

TUESDAY, Feb. 28, 2017 – Children who survive cancer are living longer. And one reason may be that fewer childhood cancers are treated with radiation today than were 20 years ago, researchers suggest. Although the study can't prove a cause-and-effect link, the researchers found that as use of radiation in childhood cancers declined dramatically, so did the number of kids with cancers that returned. "The most ominous late effect of pediatric cancer treatment is a second [cancer]. This study shows efforts to reduce the late effects of treatment are paying off," said study leader Dr. Gregory Armstrong. He's with St. Jude Children's Research Hospital's Department of Epidemiology and Cancer Control in Memphis, Tenn. "The risk of second cancers for survivors increases with age, so it is good to see the reduction emerging early in survivorship while survivors are still young," Armstrong said ... Read more

Related support groups: Cancer, Leukemia, History - Radiation Therapy, Neutropenia Associated with Radiation

Most Adult Survivors of Childhood Cancers Enjoy Good Sexual Health

Posted 6 Feb 2017 by Drugs.com

MONDAY, Feb. 6, 2017 – Treatment received in childhood to help fight cancer can have an impact on sexual health in adulthood, a new report suggests. However, the study also found that most adult survivors of childhood cancer report having satisfying sexual and romantic lives. "As positive as it is to see this, we still should be closely monitoring sexual health in adults who did have cancer treatment as children, especially those needing high-dose neurotoxic [brain-harming] treatments," said Dr. Matthew Lorber, who reviewed the new findings. He directs child and adolescent psychiatry at Lenox Hill Hospital in New York City. The new research was published online Feb. 6 in the journal Cancer and was led by Vicky Lehmann, of Nationwide Children's Hospital and Ohio State University in Columbus. Lehmann's team noted that treatment for childhood cancer can harm the developing brain in a way ... Read more

Related support groups: Birth Control, Contraception, Cancer, Erectile Dysfunction, Methotrexate, Sexually Transmitted Diseases, Female Infertility, Leukemia, Fluorouracil, Xeloda, Hydroxyurea, Ovulation Induction, Mercaptopurine, Hydrea, Capecitabine, Dacogen, Gemcitabine, Gemzar, Sexual Deviations or Disorders, Hypoactive Sexual Desire Disorder

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

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