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Showing 351 - 387Leukemia & Lymphoma Society Applauds FDA's Approval of Ibrutinib for CLL
In response to FDA's approval earlier this week of ibrutinib (Imbruvica) to treat patients with chronic lymphocytic leukemia (CLL) who had received at least one prior therapy, The Leukemia & Lymphoma Society (LLS) issued the following statement: "After the FDA designated ibrutinib as a...
Researchers Discover Preleukemic Stem Cell at Root of AML Relapse
Researchers have discovered a preleukemic stem cell that may be the first step in initiating disease and also the culprit that evades therapy and triggers relapse in patients with acute myeloid leukemia (AML). The research, published online in Nature, is a significant step forward in...
Omacetaxine Mepesuccinate Receives Full FDA Approval for CML
The U.S. Food and Drug Administration (FDA) has granted full approval to omacetaxine mepesuccinate (Synribo) for injection. The full approval was based on the final analysis of two phase II trials that evaluated the efficacy and tolerability data of omacetaxine. The agent received an accelerated...
FDA Approves Ibrutinib for the Treatment of Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) today expanded the approved use of ibrutinib (Imbruvica) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one previous therapy. Ibrutinib, an oral Bruton’s tyrosine kinase inhibitor, was previously...
FDA Approves Revised Prescribing Information for Ponatinib, Authorizes Resumption of Drug Sales and Distribution
The U.S. Food and Drug Administration (FDA) has approved revised prescribing information and a Risk Evaluation and Mitigation Strategy (REMS) for ponatinib (Iclusig) that allows immediate resumption of its marketing and commercial distribution. The prescribing information includes a revised...
Ibrutinib/Rituximab Combination Leads to High Response Rate Among Patients With CLL
Nearly all of the patients with high-risk chronic lymphocytic leukemia (CLL) in a phase II clinical trial responded to treatment with the targeted therapy ibrutinib (Imbruvica) and the antibody rituximab (Rituxan), researchers reported at the 55th American Society of Hematology (ASH) Annual Meeting ...
Gemtuzumab Ozogamicin Reduces Minimal Residual Disease in Children With High-Risk Acute Myeloid Leukemia
Combining gemtuzumab ozogamicin (Mylotarg) with conventional chemotherapy may improve the outcome of bone marrow transplantation for some children battling high-risk acute myeloid leukemia (AML), according to a study led by St. Jude Children’s Research Hospital. The results appear in the...
FDA Approves Obinutuzumab for Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) today approved obinutuzumab (Gazyva) for use in combination with chlorambucil (Leukeran) to treat patients with previously untreated chronic lymphocytic leukemia (CLL). Obinutuzumab is the first drug with Breakthrough Therapy designation to receive FDA...
Sale of Ponatinib Suspended Due to Risk of Life-Threatening Blood Clots
The U.S. Food and Drug Administration (FDA) has asked the manufacturer of the tyrosine kinase inhibitor ponatinib (Iclusig) to suspend marketing and sales of the drug because of the risk of life-threatening blood clots and severe narrowing of blood vessels. Ariad Pharmaceuticals has agreed to...
FDA Investigating Ponatinib After Increased Reports of Serious Blood Clots in Arteries and Veins
The U.S. Food and Drug Administration (FDA) is investigating an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels of patients taking the antileukemia drug ponatinib (Iclusig). Ponatinib is indicated for the treatment of patients with...
FDA Grants Volasertib Breakthrough Therapy Designation in Acute Myeloid Leukemia
Boehringer Ingelheim Pharmaceuticals, Inc, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to volasertib, an investigational inhibitor of polo-like kinase (Plk), which being evaluated for the treatment of patients aged 65 or older with...
FDA Grants Ofatumumab Breakthrough Therapy Designation for Previously Untreated CLL
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for ofatumumab (Arzerra) in combination with chlorambucil (Leukeran) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have not received prior treatment and are inappropriate for...
Researchers Uncover Genetic Cause of Childhood Acute Lymphoblastic Leukemia
For the first time, a genetic link specific to risk of childhood leukemia has been identified, according to a team of researchers from Memorial Sloan-Kettering Cancer Center, St. Jude Children’s Research Hospital, University of Washington, and other institutions. The discovery was reported...
St. Jude's Study Yields New Strategy Against High-Risk Leukemia
St. Jude Children’s Research Hospital investigators have identified a protein that certain high-risk acute lymphoblastic leukemia (ALL) cells need to survive and have used that knowledge to fashion a more effective method of killing tumor cells. The findings appear in the August 29 edition of ...
Preclinical Study Finds Tumor Suppressor May Actually Fuel Aggressive Acute Myeloid Leukemia
A study published this week in the Journal of Clinical Investigation suggests that blocking the RUNX1 protein normally credited with suppressing leukemia may be a promising therapeutic strategy for acute myeloid leukemia. Transcription Factor RUNX1 Researchers from Cincinnati Children's Hospital...
Vaccine Stirs Immune Activity Against Advanced Chronic Lymphocytic Leukemia
Patients with advanced chronic lymphocytic leukemia (CLL) often receive allogeneic transplants that effectively “reboot” their own immune defenses, which then attack and potentially cure the hard-to-treat disease. However, there is a high rate of relapse in these patients, and the...
Acute Myeloid Leukemia Induces Bone Marrow Failure by Inhibiting Production of Hematopoietic Stem Cells
Scientists studying acute myeloid leukemia (AML) have discovered that rather than displacing hematopoietic stem cells in the bone marrow as previously believed, the cancer is in fact inhibiting production of downstream hematopoietic cells, effectively putting them to sleep. The findings were...
New Drug Application Submitted for Ibrutinib in the Treatment of Two B-cell Malignancies
Pharmacyclics, Inc, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational oral Bruton's tyrosine kinase inhibitor ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL) and...
Technologies for Monitoring Minimal Residual Disease May Help Predict Outcomes for Patients with Leukemia
New evidence suggests that using advanced genetics technologies to monitor for remaining cancer cells after treatment may soon become an effective tool to inform treatment decisions and ultimately predict patient outcomes for patients with a particularly aggressive form of acute lymphocytic...
African Americans with Chronic Lymphocytic Leukemia Do Not Live as Long as Caucasians, Despite Equal Care
A new analysis has found that among patients with chronic lymphocytic leukemia (CLL), African Americans more commonly present with advanced disease and tend to have shorter survival times than Caucasians despite receiving the same care. The results, published early online in Cancer, suggest that...
FDA Grants Priority Review to Obinutuzumab in CLL and Pertuzumab in Neoadjuvant Therapy for HER2-positive Early-stage Breast Cancer
Two drugs were given Priority Review designation by FDA earlier this week. Obinutuzumab (GA101) was granted Priority Review for the treatment of chronic lymphocytic leukemia (CLL), based on final stage 1 data from the pivotal CLL11 trial. FDA also granted Priority Review to a pertuzumab (Perjeta)...
Ofatumumab plus Chlorambucil Improves Progression-free Survival in Patients with Previously Untreated CLL
In a phase III study, patients with previously untreated chronic lymphocytic leukemia (CLL) achieved an improvement in progression-free survival when treated with ofatumumab (Arzerra) in combination with chlorambucil vs chlorambucil alone. The study evaluated safety and efficacy of ofatumumab plus ...
Intensified Liposomal Daunorubicin May Offer High Survival Rates without Added Cardiotoxicity for Children with Leukemia
Treating pediatric leukemia patients with a liposomal formulation of anthracycline-based chemotherapy at an intensified dose during initial treatment may result in high survival rates without causing any added heart toxicity, according to the results of a study published online in Blood, the...
ASCO 2013: New Drug Targeting PI3K-delta Shows Strong Activity in Early Trial for High-risk Chronic Lymphocytic Leukemia
Results from a phase I study of a new oral targeted drug, idelalisib (GS-1101), show the agent has potential as a therapy for relapsed or treatment-resistant chronic lymphocytic leukemia (CLL). The drug produced rapid and long-lasting tumor shrinkage in half of the patients treated with...
Study Identifies Possible New Treatment Target for Acute Leukemia
A study has identified microRNA-155 as a new independent prognostic marker and treatment target in patients with cytogenetically normal acute myeloid leukemia (AML). The study was led by researchers at the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital...
Pharmacyclics Completes Enrollment of Phase III Ibrutinib CLL Study and Phase II Ibrutinib MCL Study
Pharmacyclics, Inc, announced today that the enrollment target of 350 patients for RESONATE, its phase III study using ibrutinib monotherapy vs ofatumumab (Arzerra) in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, was achieved on April 3, 2013. As...
Key Bone Marrow Protein Identified as Potential New Leukemia Treatment Target
A new study on how the progression of acute lymphocytic leukemia (ALL) is influenced by the bone marrow environment has demonstrated for the first time that targeting a specialized protein known as osteopontin may be an effective strategy to increase the efficacy of chemotherapy in patients with...
Immunotherapy Showed Promising Antileukemia Activity in Pediatric Patients
Researchers using patients’ own immune cells in an immunotherapy approach called anti-CD19 chimeric antigen receptor (CAR) T-cell therapy achieved responses in children whose acute lymphocytic leukemia (ALL) had returned after a bone marrow transplant, according to preliminary results...
Ibrutinib Receives Third Breakthrough Therapy Designation from the FDA
Pharmacyclics, Inc, announced today that the FDA has granted an additional Breakthrough Therapy Designation for the investigational oral agent ibrutinib as monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma with deletion of the short arm...
Monoclonal Antibody Targets, Kills Leukemia Cells
Researchers at the University of California, San Diego Moores Cancer Center have identified a humanized monoclonal antibody that targets and directly kills chronic lymphocytic leukemia (CLL) cells. The findings, published in the online Early Edition of the Proceedings of the National Academy of...
Inherited Genetic Variations Have a Major Impact on Childhood Leukemia Risk
Humans have between 20,000 and 25,000 genes that carry instructions for assembling the proteins that do the work of cells. Work led by St. Jude Children’s Research Hospital found that children who inherit certain variations in four particular genes are at much higher risk of developing acute...
St. Jude Children's Research Hospital Announces Issuance of U.S. Patent for Genetically Modified Human Immune Cells for Cancer Therapy
The United States Patent and Trademark Office today awarded St. Jude Children's Research Hospital U.S. patent number 8,399,645 for its invention of compositions for genetically modifying human immune cells so they can destroy some of the most common forms of cancer in children and adults. "This...
Infusion of Stem Cells and Specially Generated T-cells from Same Donor Improves Leukemia Survival
In a significant advance for harnessing the immune system to treat leukemias, researchers at Fred Hutchinson Cancer Research Center have successfully infused large numbers of donor-derived T cells specific for a key antileukemic antigen in order to prolong survival in high-risk and relapsed...
Risk of Leukemia After Cancer Chemotherapy Persists
While advancements in cancer treatment over the last several decades have improved patient survival rates for certain cancers, some patients remain at risk of developing treatment-related leukemia, according to results of a study published online in Blood, the Journal of the American Society of...
Researchers Discover Mutations Linked to Relapse Of Childhood Leukemia
After an intensive 3-year hunt through the genome, researchers have pinpointed mutations that lead to drug resistance and relapse in acute lymphoblastic leukemia (ALL) ,the most common type of childhood cancer—the first time anyone has linked the disease’s reemergence to specific...
Imatinib Receives New Indication for Children with Acute Lymphoblastic Leukemia
The FDA approved a new use of imatinib (Gleevec) to treat children newly diagnosed with Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL). ALL is the most common type of pediatric cancer, affecting approximately 2,900 children annually, and progresses quickly if untreated....
Genetic Basis of High-risk Childhood Cancer Points to Possible New Drug Treatment Strategy
Research led by St. Jude Children’s Research Hospital scientists has identified a possible lead in treatment of two childhood leukemia subtypes known for their dramatic loss of chromosomes and poor treatment outcomes. The findings also provide the first evidence of the genetic basis for ...
