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Over the past week, the U.S. Food and Drug Administration (FDA) granted multiple Priority Reviews and accepted a supplemental new drug application: Priority Review for Entrectinib in NTRK Fusion–Positive Solid Tumors and Metastatic, ROS1-Positive NSCLC This week, the FDA accepted new drug...
Scientists have identified genetic variations in a fourth gene that are associated with an increased risk of acute lymphoblastic leukemia (ALL) in Hispanic children. These findings were published by Qian et al in Blood. The gene is ERG, a transcription factor that is also...
ON JANUARY 28, 2019, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica), a Bruton’s tyrosine kinase inhibitor, in combination with obinutuzumab in treatment-naive patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This is the first approval of...
The benefit of adding venetoclax to a hypomethylating agent or low-dose cytarabine in the front-line treatment of acute myeloid leukemia (AML) was evident from a number of studies reported at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition (see Table 1). For elderly...
In a retrospective study reported in the Journal of Clinical Oncology, Pui et al found that minimal residual disease (MRD)-negative status, high hypodiploidy with 44 chromosomes, and MRD-stratified treatment were associated with improved outcomes among children treated for newly diagnosed...
Today, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica), a Bruton's tyrosine kinase inhibitor, in combination with obinutuzumab in treatment-naive patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This is the first approval of a...
In a phase I trial reported in the Journal of Clinical Oncology, Craddock et al found evidence that the sequential combination of azacitidine and lenalidomide may be an effective salvage therapy in patients with acute myeloid leukemia (AML) relapsing after allogeneic stem cell transplantation...
ELIHU H. ESTEY, MD, Professor of Medicine at the University of Washington and Director of Acute Myeloid Leukemia (AML) Clinical Research at the Fred Hutchinson Cancer Research Center, Seattle, added that with these “robust” outcomes, future trial patients may “not be eager to wind up in the...
IN AN OPEN-LABEL phase I study of 153 patients newly diagnosed with acute myeloid leukemia (AML) and mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2, treatment with standard chemotherapy plus the oral IDH inhibitors ivosidenib and enasidenib led to high response rates and possibly impressive ...
JOSEPH MIKHAEL, MD, press conference moderator where these data were discussed, commented on the BEAT AML trial: “One of the greatest challenges in the concept of personalized medicine is that by the time you determine what is right for a patient [ie, genomic analysis], the horse is out of the...
THE MULTIARM, multicollaborative BEAT AML umbrella trial demonstrated the feasibility of using next-generation sequencing to assign treatment tailored to individual genomics of elderly patients with acute myeloid leukemia (AML) within 7 days. This may prove to be a major advance, since typically...
Investigators have identified multiple new subtypes of the most common childhood cancer, B-cell acute lymphoblastic leukemia (ALL)—research that has the potential to improve the diagnosis and treatment of high-risk patients. Researchers used integrated genomic analysis, including...
In the summer of 2002, I was a physically active 17-year-old boy on the cusp of adulthood. I was about to enter my senior year in high school, and like other teens my age, I was excited about college and the promise of the undreamed-of opportunities that lay ahead. At first, the lethargy I was...
Findings from a new study by researchers at the National Cancer Institute (NCI) show that patients treated with chemotherapy for most solid tumors from 2000 to 2014 experienced an increased risk of therapy-related myelodysplastic syndrome/acute myeloid leukemia (MDS/AML). The study, which used U.S. ...
On January 2, the U.S. Food and Drug Administration (FDA) expanded the indication for dasatinib (Sprycel) tablets to include the treatment of pediatric patients 1 year of age and older with newly diagnosed Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL) in...
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) accepted a new drug application and granted Priority Review to quizartinib, a FLT3 inhibitor, for the treatment of adult patients with relapsed or refractory FLT3-ITD–positive acute myeloid leukemia (AML). The FDA is expected to make a decision on...
On November 21, 2018, venetoclax (Venclexta) was granted accelerated approval for use in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients aged ≥ 75 years or who have comorbidities that preclude the use of ...
On December 20, 2018, the U.S. Food and Drug Administration (FDA) approved calaspargase pegol-mknl (Asparlas), an asparagine-specific enzyme, as a component of a multiagent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients aged 1 month to...
In patients with relapsed or refractory chronic lymphocytic leukemia (CLL), fixed-duration venetoclax -(Venclexta) combined with rituximab (Rituxan) reduced the risk of disease progression or death compared with standard-of-care bendamustine/rituximab, according to longer-term follow-up of the...
Researchers are combining chimeric antigen receptor (CAR) T-cell therapy with ibrutinib (Imbruvica) as a means of augmenting and deepening responses in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Two pilot studies presented at the 2018 American Society of Hematology...
Researchers recently discovered that by testing the level of nucleotide excision repair (NER) gene expression, pediatric oncologists may be able to determine the likelihood of early relapse (less than 3 years) in patients with acute lymphoblastic leukemia (ALL). These findings were published by...
In a phase III trial reported at the recent American Society of Hematology Annual Meeting & Exposition and in The New England Journal of Medicine by Woyach et al, ibrutinib (Imbruvica) and ibrutinib/rituximab (Rituxan) were associated with superior progression-free survival vs...
First-line therapy with the combination of ibrutinib (Imbruvica) and rituximab (Rituxan) reduced disease progression by two-thirds compared with standard chemotherapy using fludarabine, cyclophosphamide, and rituximab (FCR) in younger patients with chronic lymphocytic leukemia (CLL), according to...
As reported in the Journal of Clinical Oncology by Kater et al, high undetectable minimal residual disease (MRD) rates persisted after the end of venetoclax (Venclexta)/rituximab (Rituxan) treatment in the phase III MURANO trial in relapsed or refractory chronic lymphocytic leukemia (CLL), and were ...
In a report in the Journal of Oncology Practice, Morris et al described an initiative that has been successful in reducing the incidence of invasive fungal infections in patients with acute myeloid leukemia (AML) receiving induction and reinduction therapy at the University of Virginia Health...
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Priority Review for Atezolizumab in Combination With Chemotherapy for the Initial Treatment of Extensive-Stage SCLC The FDA accepted a supplemental biologics license application...
ON SEPTEMBER 13, 2018, moxetumomab pasudotox-tdfk (Lumoxiti), a CD22-directed cytotoxin, was approved for the treatment of adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including with a purine nucleoside analog.1,2 Supporting...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On September 24, 2018, duvelisib (Copiktra) was granted...
THE STUDY’S discussant, Susan M. O’Brien, MD, Associate Director for Clinical Science, Chao Family Comprehensive Cancer Center, University of California Irvine Health, said the results of the Alliance North American Intergroup Study A041202—demonstrating that ibrutinib (Imbruvica) is more...
IBRUTINIB (IMBRUVICA) as a front-line agent proved superior to standard-of-care chemoimmunotherapy for chronic lymphocytic leukemia (CLL) in older patients in A041202, an Alliance-led National Clinical Trials Network study.1 At a follow-up of 38 months, the median progression-free survival was not ...
BOOKMARK Title: Cancer Crossings: A Brother, His Doctors, and the Quest for a Cure to Childhood LeukemiaAuthor: Tim WendelPublisher: ILR PressPublication date: April 2018Price: $24.95, hardcover, 256 pages Tim Wendel is a journalist and author of several noted books, mostly concerning sports. In...
Investigators from Australia have identified a genetic mutation that causes resistance to the targeted drug venetoclax (Venclexta) in patients with chronic lymphocytic leukemia (CLL), according to research presented by Blombery et al at the 2018 American Society of Hematology (ASH) Annual Meeting...
A 6-month course of chemotherapy-based treatment with FCR (intravenous fludarabine and cyclophosphamide plus rituximab [Rituxan]) has historically been the most effective treatment for chronic lymphocytic leukemia (CLL), especially in patients 70 years of age and younger. However, results from a...
Tait D. Shanafelt, MD, of Stanford University, discusses phase III study findings on ibrutinib-based therapy vs standard fludarabine, cyclophosphamide, and rituximab chemoimmunotherapy in untreated younger patients with chronic lymphocytic leukemia (Abstract LBA4).
Shaji K. Kumar, MD, of the Mayo Clinic, discusses phase III findings on daratumumab plus lenalidomide and dexamethasone vs lenalidomide and dexamethasone in people with newly diagnosed multiple myeloma who are ineligible for transplant (Abstract LBA2).
Saar I. Gill, MD, PhD, of the University of Pennsylvania, discusses findings from a prospective clinical trial on the high response rate in patients with chronic lymphocytic leukemia who received a combination therapy of CAR T cells plus ibrutinib (Abstract 298).
Julie Vose, MD, MBA, of the University of Nebraska Medical Center, and Merav Bar, MD, of the Fred Hutchinson Cancer Research Center, discuss study findings on the long-term effects in people with relapsed or refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia who received CD19-targeted CAR T-cell infusions, survived more than a year, and had at least 1 year of follow-up data after their first treatment (Abstract 223).
Andreas Burchert, MD, of the Philipps University of Marburg, discusses study findings on sorafenib as maintenance therapy after allogeneic stem cell transplantation for FLT3-ITD–positive acute myeloid leukemia.
A new study demonstrated it is feasible for health-care providers to determine which molecular subtype of acute myeloid leukemia (AML) a patient has before beginning treatment and to use this information to pick an approach that best matches the individual. The results, presented by Burd et al at...
Jennifer Ann Woyach, MD, of The Ohio State University, discusses trial findings on ibrutinib alone or in combination with rituximab compared with bendamustine plus rituximab in untreated older people with chronic lymphocytic leukemia (Abstract 6).
In a new study presented by Summers et al at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 967), patients with acute lymphoblastic leukemia (ALL) who received a first stem cell transplant after CD19 chimeric antigen receptor (CAR) T-cell therapy were less...
CD19-directed chimeric antigen receptor (CAR) T-cell therapy has been shown to be effective in patients with relapsed B-cell acute lymphocytic leukemia (B-ALL). However, in some patients, the antitumor effects of CAR T-cell treatment are short-lived, which may, in part, be caused by a reaction of...
For patients with difficult-to-treat chronic lymphocytic leukemia (CLL), continuing to take ibrutinib (Imbruvica) before, during, and after receiving chimeric antigen receptor (CAR) T-cell therapy may be associated with less severe adverse effects and better responses compared with outcomes for a...
A single infusion of tisagenlecleucel (Kymriah) in pediatric and young adult patients with relapsed or treatment-resistant acute lymphocytic leukemia (ALL) continues to be highly effective in most patients, without the need for additional therapies. This latest analysis of the ELIANA trial results...
A new study presented by Woyach et al at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 6) showed that older patients with chronic lymphocytic leukemia (CLL) have a significantly lower rate of disease progression if treated with ibrutinib rather than...
A triplet therapy combining two immune checkpoint inhibitors with the standard of care azacitidine has shown promising results for treatment of relapsed or refractory acute myeloid leukemia (AML), according to the findings of a phase II study conducted at The University of Texas...
In a German phase II trial (RELAZA2) reported in The Lancet Oncology, Platzbecker et al found that minimal residual disease (MRD)–guided treatment with azacitidine was successful in preventing hematologic relapse in patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia...
Today, the U.S. Food and Drug Administration (FDA) approved gilteritinib (Xospata) for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. The FDA also approved an expanded indication for a companion ...
On November 21, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to venetoclax (Venclexta) in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older or...
Despite survival gains for children diagnosed with acute lymphoblastic leukemia (ALL), adolescents and young adults (AYAs)— those between the ages of 15 and 39— diagnosed with the disease have seen only modest improvements in survival. A study by Julie A. Wolfson, MD, MSHS, Assistant Professor and ...