© 2024 HSP News Service, L.L.C.
Pharmacyclics, Inc, announced 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 of...
As was recently reported in Science Translational Medicine, Renier J. Brentjens, MD, and colleagues at Memorial Sloan-Kettering Cancer Center, New York, found that profound molecular remission was rapidly induced in patients with relapsed B-cell acute lymphoblastic leukemia (ALL) using autologous T ...
Quality nursing and ongoing education are critical for success in using gene-modified T-cell therapy for patients with chronic lymphocytic leukemia (CLL), said Cheryl Caravano, RN, at the recent Annual Congress of the Oncology Nursing Society. Ms. Caravano is a clinical nurse IV at Memorial...
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.1 Acute...
Findings from the Dana-Farber Cancer Institute ALL Consortium Protocol 00-01, recently reported by Lynda M. Vrooman, MD, Dana-Farber Cancer Institute, and colleagues in Journal of Clinical Oncology, indicate that postinduction dexamethasone and individualized dosing of Escherichia coli–derived...
Heavily pretreated patients with chronic lymphocytic leukemia (CLL) responded robustly to the first-in-class small-molecule inhibitor idelalisib (formerly GS1101), in a phase I dose-finding study reported in a press briefing prior to the 2013 ASCO Annual Meeting.1 Idelalisib, a specific inhibitor...
Even as a child, Janet D. Rowley, MD, found the intellectual order and logic of science appealing. Born on April 5, 1925, in New York, Dr. Rowley’s parents, Hurford and Ethel Ballantyne Davison, moved the family to Chicago 2 years later. Both educators, the Davisons encouraged their only child in...
Acute lymphoblastic leukemia (ALL) is the most common cancer in children, and the incidence of the disease varies by ethnicity. Available evidence indicates an inherited predisposition to ALL, but the genetic basis of ALL susceptibility in diverse ancestry has not been examined in detail. Xu and...
The Leukemia & Lymphoma Society (LLS) recently joined the Dana-Farber Cancer Institute in Boston to establish a network of sites for clinical trial testing of innovative blood cancer therapies in community oncology settings across the country. This Blood Cancer Research Partnership (BCRP) will...
Among the hematologic cancers for which molecular causes remain unclear are chronic neutrophilic leukemia and atypical (BCR-ABL1–negative) chronic myeloid leukemia. Both disorders currently are diagnosed on the basis of neoplastic expansion of granulocytic cells and exclusion of genetic factors...
Acute myeloid leukemia (AML) is a clinically and molecularly heterogeneous disease.1 This concept has been supported by more than 4 decades of studies showing distinct outcomes of subsets of patients that differ in age, disease type (primary vs secondary vs therapy-related), and cytogenetic and...
In a study by the Cancer Genome Atlas Research Network reported in The New England Journal of Medicine, genomes of 200 adult cases of de novo acute myeloid leukemia (AML) were analyzed by whole-genome sequencing (n = 50) or whole-exome sequencing (n = 150) to identify mutations and relationships...
A trio of presentations at the ASCO Annual Meeting focused on two promising investigational drugs for the treatment of chronic lymphocytic leukemia (CLL). These two drugs—idelalisib and obinutuzumab—join a list of new approaches showing potential. Idelalisib Alone A phase I dose-ranging study of...
Treatment with lenalidomide (Revlimid) as initial therapy induced long-lasting responses in a phase II study of 60 patients with chronic lymphocytic leukemia (CLL). “Overall, 35 patients (58%) patients had responses lasting more than 36 months and were considered long-term responders,” the...
Among the more than 200 types of cancer are those called “forgotten” or “orphan” cancers, with fewer than 40,000 new cases each year. They present treatment challenges in community cancer centers. Because of the low incidence of these diseases, such as chronic myeloid leukemia, acute promyelocytic...
Two drugs were recently given Priority Review designation by FDA. Obinutuzumab (GA101) was granted Priority Review for the treatment of chronic lymphocytic leukemia, based on final stage 1 data from the pivotal CLL11 trial. The FDA confirmed the action date is December 20, 2013. FDA also granted...
The 12th International Conference on Malignant Lymphoma was held June 19-22, 2013, in Lugano, Switzerland. Over 3,000 hematologists, clinical oncologists, pathologists, and leading researchers attended the meeting, which featured new research on B-cell malignancies, follicular lymphoma, as well as...
Pharmacyclics, Inc, recently 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)...
All-trans retinoic acid (ATRA) plus arsenic trioxide bested the already high remission rates achieved by ATRA with chemotherapy, the standard of care for acute promyelocytic leukemia, in a phase III multicenter trial among patients with low-to-intermediate risk acute promyelocytic leukemia....
Durable remissions are uncommon with current treatments for relapsed chronic lymphocytic leukemia (CLL). Bruton’s tyrosine kinase is an essential component of B cell–receptor signaling that mediates interactions with the tumor microenvironment and promotes survival and proliferation of CLL cells....
A retrospective analysis of 110 patients with juvenile myelomonocytic leukemia found that single-unit, unrelated donor umbilical cord blood transplantation resulted in a 5-year disease-free survival rate of 44%. “Our data document that a significant proportion of children with this disease,...
The ASCO Post article, “Ibrutinib CLL Trial: Where is the Equipoise?” published in May 2013, inaccurately conveyed that the Food and Drug Administration (FDA) requires an improvement in overall survival for chronic lymphocytic leukemia (CLL) drug approval and opposes allowing crossover in the...
We acknowledge the letters submitted to The ASCO Post from a patient advocate and a chronic lymphocytic leukemia (CLL) patient enrolled on the RESONATE study (PCYC-1112-CA). At Pharmacyclics, we are committed to adhering to high scientific and ethical standards as we strive to develop novel...
In a previous issue of The ASCO Post, Dr. Susan O’Brien wrote, “It is my understanding that the FDA strongly opposed allowing crossover [in the RESONATE trial]. I presume that is because the FDA also wants to see if there is a survival advantage.”1 The lack of crossover seems a valid concern to me...
I am writing with regard to two articles on the ethical imperative of clinical equipoise written by Susan O’Brien, MD, and Stephen J. Schuster, MD, and published recently in The ASCO Post.1,2 I was a victim of Pharmacyclics’ policies during one of their randomized ibrutinib trials (PCI-32765)...
Disease recurrence is a devastating event after allogeneic hematopoietic stem cell transplantation as treatment for acute myeloid leukemia (AML). Median time to relapse is approximately 4 months and the majority of relapses occur within 2 years after transplant. The prognosis is usually poor....
Minimal data are available on outcomes of second allogeneic hematopoietic stem cell transplantation from unrelated donors after a first transplant in patients with hematologic relapse of acute leukemia. In a study reported in Journal of Clinical Oncology, Maximilian Christopeit, MD, of University...
“The management of chronic lymphocytic leukemia (CLL) is undergoing profound changes. Several new drugs have been approved for CLL treatment (fludarabine, bendamustine [Treanda], and the monoclonal antibodies alemtuzumab [Campath], rituximab [Rituxan], and ofatumumab [Arzerra]), and many more drugs ...
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...
The U.S. Food and Drug Administration (FDA) has 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...
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...
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. Indication On November 1, 2013, obinutuzumab (Gazyva) was approved...
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...
Reports have been trickling in from centers conducting research on the use of chimeric antigen receptor–modified T cells (CAR-T) in hematologic cancer, and the news is encouraging. When directed against CD19, such personalized therapeutic T cells are known as CTL019, and small pilot trials of this...
“He gave his honours to the world again,his blessed part to heaven, and slept in peace.” —William Shakespeare, Henry VIII In 1971, John M. Goldman, DM, FRCP, FRCPath, FMedSci, began research in chronic myeloid leukemia (CML), a uniformly fatal disease at the time. Over the ensuing decades, Dr....
Bosutinib (Bosulif) demonstrated “acceptable safety with manageable toxicities” in a phase I/II study among patients with chronic-phase chronic myeloid leukemia (CML) or advanced Philadelphia chromosome–positive leukemia (accelerated-phase/blast-phase CML or acute lymphoblastic leukemia). Patients...
Although many oncologists consider matched sibling donors as the best source of grafts for hematopoietic cell transplantation, two separate studies presented at the recent American Society of Hematology Annual Meeting support the use of alternative donor grafts for patients with lymphoma and acute...
Reduced-intensity conditioning and myeloablative-conditioning regimens following allogeneic hematopoietic cell transplantation in children with acute myeloid leukemia (AML) resulted in comparable survival, according to a study published in Blood. The study evaluated 181 patients, 39 treated with...
Many of the advances that have bettered mankind are attributed to those who were driven by a primary passion. Geoffrey P. Herzig, MD, lived the better part of his life with a primary passion: conducting research to increase the cure rate of leukemia and lymphoma patients. His friend and colleague,...
A randomized phase III trial conducted in 26 countries found that combining chlorambucil (Leukeran) with an anti-CD20 antibody—either obinutuzumab (Gazya) or rituximab (Rituxan)—produced better outcomes among patients with previously untreated chronic lymphocytic leukemia (CLL) and coexisting...
The U.S. Food and Drug Administration (FDA) has approved the Miltenyi Biotec’s CliniMACS CD34 Reagent System as a Humanitarian Use Device for the prevention of graft-vs-host disease in patients with acute myeloid leukemia (AML) in first complete remission undergoing allogeneic stem cell...
Two novel agents have shown promising activity in chronic lymphocytic leukemia (CLL), including poor-risk patients: the Bcl-2 inhibitor ABT-199 and the small-molecule PI3K inhibitor IPI-145. Both drugs achieved excellent response rates in heavily pretreated relapsed/refractory patients including...
Obinutuzumab (Gazyva) plus chloramubucil outperformed rituximab (Rituxan) plus chlorambucil (Leukeran) as first-line therapy in older patients with chronic lymphocytic leukemia (CLL) and comorbidities in the large CLL 11 trial. Final results showed that obinutuzumab/chloramubucil improved overall...
The U.S. Food and Drug Administration (FDA) has 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 granted...
Central nervous system–directed chemotherapy and cranial radiotherapy for childhood acute lymphoblastic leukemia or lymphoma have neurotoxic effects. In a study reported in Journal of Clinical Oncology, Ilse Schuitema, MSc, of Leiden University, and colleagues evaluated white matter changes and...
On February 12, 2014, ibrutinib (Imbruvica) was granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.1,2 Ibrutinib previously received accelerated approval for the treatment of patients with mantle cell...
The availability of the tyrosine kinase inhibitor imatinib (Gleevec) has dramatically increased survival in chronic myeloid leukemia (CML). Nonadherence to therapy with imatinib and other tyrosine kinase inhibitors is associated with disease progression and treatment resistance. In a study reported ...
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 ...