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The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the investigational drug pracinostat for the treatment of acute myeloid leukemia (AML). The FDA’s Orphan Drug Designation program provides orphan status to drugs defined as those intended for the safe and effective...
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...
The monoclonal antibody gemtuzumab ozogamicin (Mylotarg) improved event-free survival and reduced the risk of relapse in children with acute myeloid leukemia (AML) in a study from the Children’s Oncology Group, presented at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition ...
Idelalisib plus rituximab (Rituxan) improved progression-free survival, overall response rates, and overall survival compared with rituximab alone in heavily pretreated patients with relapsed chronic lymphocytic leukemia (CLL). Moreover, the combination provided effective, durable disease control...
Minimal residual disease after induction and consolidation for the treatment of acute leukemia might be eradicated by novel therapies, thus obviating the need for stem cell transplantation. That is the prediction of Matthew J. Wieduwilt, MD, PhD, Assistant Clinical Professor of Medicine at the...
In patients with acute leukemia, outcomes after hematopoietic stem cell transplantation are negatively impacted by the presence of minimal residual disease. However, transplant can prolong survival in patients with minimal residual disease after consolidation, according to two studies presented at...
Receiving rituximab (Rituxan) with idelalisib, rather than rituximab with placebo, “significantly improved progression-free survival, response rate, and overall survival” among patients with relapsed chronic lymphocytic leukemia (CLL) who were less able to undergo chemotherapy because of clinically ...
Patients with chronic myeloid leukemia (CML) in the chronic phase who are resistant or intolerant to imatinib (Gleevec) can experience long-term benefit with dasatinib (Sprycel), according to long-term results of a randomized phase III study. The CA180-034 study also found that early molecular and...
In a study reported in the Journal of the National Cancer Institute, Carter and colleagues identified deregulated apoptotic components in acute myeloid leukemia (AML) stem/progenitor cells and investigated the effects of the novel inhibitor of apoptosis (IAP) protein antagonist and SMAC mimetic...
The U.S. Food and Drug Administration (FDA) has approved ofatumumab (Arzerra) injection in combination with chlorambucil (Leukeran) for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL), for whom fludarabine-based therapy is considered inappropriate. The...
The Leukemia & Lymphoma Society (LLS) has announced that it has passed the $1 billion mark in research investment, a significant milestone in the cancer research landscape as the Society continues its 65-year pursuit of advancing breakthrough therapies, finding cures, and ensuring access to...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 17, 2014, ofatumumab (Arzerra) received regular approval...
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to volasertib for acute myeloid leukemia. Volasertib is currently being evaluated in a phase III clinical trial for the treatment of patients aged 65 or older, with previously untreated AML, who are ineligible for...
Pharmacyclics, Inc, and Janssen Biotech, Inc, have announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA), based on data from the randomized, multicenter, open-label phase III RESONATE study, a head-to-head comparison of single-agent ibrutinib ...
On April 28, 2014, the U.S. Food and Drug Administration approved a 20 mg/mL oral suspension of mercaptopurine (Purixan) indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination regimen. Successive clinical trials have demonstrated that mercaptopurine ...
Although the data are preliminary, experts were impressed with responses to a novel IDH2 inhibitor called AG-221 in patients with hematologic malignancies. In the first clinical trial of AG-221, there were three complete remissions, two complete remissions with incomplete platelet count recovery...
At the 19th Annual Conference of the National Comprehensive Cancer Network (NCCN), held recently in Hollywood, Florida, NCCN Panel members presented updates for several tumor types, briefly summarized here. For a more complete description of all updates, visit www.nccn.org. Breast Cancer Guidelines ...
It’s the dawn of a new era in the treatment of chronic lymphocytic leukemia (CLL), largely due to the development of agents targeting the BCR signaling pathway, according to John C. Byrd, MD, of The Ohio State University Comprehensive Cancer Center, Columbus. At the 19th Annual Conference of the...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 28, 2014, an oral suspension of mercaptopurine (Purixan) ...
Ibrutinib (Imbruvica) significantly improved progression-free survival, overall survival, and response when compared with ofatumumab (Arzerra) as second-line treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in the phase III RESONATE study. The study results were...
An estimated 25% of children in remission from acute lymphocytic leukemia (ALL) are missing too many doses of the oral agent mercaptopurine, a maintenance medication that minimizes their risk of relapse when taken every day for 2 years, according to a study recently published online in Blood.1 The...
The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to blinatumomab for adults with Philadelphia chromosome–negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL). Blinatumomab is an investigational bispecific T-cell engager antibody...
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy status to CTL019, an investigational chimeric antigen receptor (CAR) therapy for the treatment of pediatric and adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL). The Breakthrough Therapy filing...
In a study reported in Science Translational Medicine, Perova and colleagues found that pre–B-cell receptor–independent spleen tyrosine kinase signaling was necessary for leukemic B-cell survival and proliferation in a mouse model. Investigation of samples from pediatric and adult B-cell acute...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 28, 2014, the approved use of ibrutinib (Imbruvica) in...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 23, 2014, idelalisib (Zydelig) was approved for use in...
Recent approvals announced by the U.S. Food and Drug Administration (FDA) have led to increased treatment options for managing several difficult-to-treat hematologic B-cell cancers. The newly approved drugs and/or their indications include the oral PI3K delta inhibitor idelalisib (Zydelig) for the...
If Anand P. Jillella, MD, has his way, no future patient with acute promyelocytic leukemia (APL) will experience a delay in treatment or lack for an expert consult—and few, if any, will die of this condition. Mortality from APL is much higher than most oncologists think, especially during the first ...
Protocol modifications to address increased risk of toxicity and excess early mortality among children with Down syndrome being treated for B-cell acute lymphoblastic leukemia (ALL) proved safe for patients with Down syndrome, and these patients had event-free survival similar to those without Down ...
Advances in allogeneic hematopoietic cell transplantation for children with acute myeloid leukemia (AML) have resulted in less toxic pretransplant conditioning regimens and expanded access to transplantation, but post-treatment leukemic relapse remains a big problem. The progress and continuing...
With the emergence of molecular diagnostics and new therapeutics, the treatment of acute myeloid leukemia (AML) is entering a new era. Hugo F. Fernandez, MD, Associate Chief of Blood and Marrow Transplantation at Moffitt Cancer Center in Tampa, Florida, spoke with The ASCO Post about how he...
The combination of bendamustine (Treanda), fludarabine, and rituximab (Rituxan), or BFR, was shown to be safe and effective conditioning for patients with relapsed chronic lymphocytic leukemia/lymphoma receiving allogeneic stem cell transplantation from related or unrelated donors. “Remarkably,...
The tumor suppressor PTEN, which is underexpressed in many cancers, dephosphorylates phosphatidylinositol (3,4,5)-triphosphate and thus inhibits activity of phosphatidylinositol 3-kinases involved in growth factor and survival factor signaling through effectors such as Akt and mTOR. As reported in...
Final results from the phase I/II GAUGUIN study showed that obinutuzumab (Gazyva) monotherapy was active in patients with heavily pretreated relapsed or refractory chronic lymphocytic leukemia, European researchers reported in Blood. In phase II, median progression-free survival was 10.7 months and ...
For a year before I was diagnosed with acute myeloid leukemia (AML) in December 2011, I had what I thought were the lingering remnants of a bad case of bronchitis. My breathing was labored, I had a chronic cough, and occasionally my voice would give out. Every time I saw my pulmonologist, I would...
The U.S. Food and Drug Administration (FDA) has accepted for review Amgen’s Biologics License Application for blinatumomab for the treatment of adults with Philadelphia chromosome–negative relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL). As part of the acceptance, the FDA granted ...
Recent articles on developments and controversies in the treatment of chronic lymphocytic leukemia include the following features from The ASCO Post, which are also available at www.ascopost.com: “Recent FDA Approvals Foster Growing Treatment Armamentarium for Chronic Lymphocytic Leukemia and Rare ...
Recent discoveries in biology, therapy, and (most importantly) the interplay between these two have led to groundbreaking advances in chronic lymphocytic leukemia (CLL). These advances underline the impact of the “translational” approach to cancer management in general. Standard of Care...
Responses to cytarabine-based therapy in acute myeloid leukemia (AML) are often of short duration. Ribavirin has been used to inhibit the eukaryotic translation initiation factor (eIF4E) and has produced responses, including remissions, in AML, but relapse invariably occurs. As reported in Nature,...
The outcome for adolescents and young adults with acute lymphoblastic leukemia (ALL) is inferior to that in children, and the outcome for children with ALL who experience relapse is dismal. Therefore, new therapeutic options are urgently needed to improve survival rates for this high-risk ALL...
In a study reported in The New England Journal of Medicine, Kathryn G. Roberts, PhD, of St. Jude Children’s Research Hospital, and colleagues performed detailed genomic analysis of patients with Philadelphia chromosome–like acute lymphoblastic leukemia (ALL) and identified kinase-activating...
The treatment of acute promyelocytic leukemia (APL) represents one of the major triumphs in the field of hematologic malignancies. With either the vitamin A derivative all-trans retinoic acid (ATRA) combined with anthracycline-based chemotherapy or ATRA plus arsenic trioxide (Trisenox),...
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to BGB324 for the treatment of acute myeloid leukemia (AML). BGB324 is a first-in-class, highly selective small-molecule inhibitor of the Axl receptor tyrosine kinase. It blocks the epithelial-mesenchymal transition...
In a study reported in The New England Journal of Medicine, Shannon L. Maude, MD, PhD, of Children’s Hospital of Philadelphia, and Noelle Frey, MD, of the Perelman School of Medicine, University of Pennsylvania, and colleagues reported achieving sustained remissions in children and adults with...
"Obesity is associated with cancer mortality,” said Steven D. Mittelman, MD, PhD, at the recent American Association for Cancer Research (AACR) International Conference on Frontiers in Cancer Prevention Research.1 Dr. Mittelman presented a wealth of data to explain the link between obesity and...
Final results from the phase I/II GAUGUIN study showed that obinutuzumab (Gazyva) monotherapy was active in patients with heavily pretreated relapsed or refractory chronic lymphocytic leukemia, European researchers reported in Blood. In phase II, median progression-free survival was 10.7 months,...
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to blinatumomab (Blincyto) for the treatment of patients with Philadelphia chromosome–negative, relapsed or refractory precursor B-cell acute lymphoblastic leukemia (B-cell ALL). Blinatumomab is a bispecific...
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to JCAR015, an investigational chimeric antigen receptor therapy developed by Juno Therapeutics. The designation applies for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia and was...
The long-term outcome for patients with relapsed or refractory acute lymphoblastic leukemia (ALL) is poor, with 5-year overall survival from first relapse being only approximately 10%.1,2 Patients with disease relapse following allogeneic transplant have the worse prognosis and are typically...
“All great truths begin as blasphemies.” —George Bernard Shaw (Annajanksa, 1918) Until about 15 years ago, persons with acute myelogenous leukemia (AML) were considered candidates to receive a blood cell or bone marrow allotransplant in first remission only if they had had an HLA-identical...