Recently, the U.S. Food and Drug Administration (FDA) approved the inclusion of overall survival from the PACIFIC trial in the U.S. prescribing information for durvalumab and accepted applications for a new drug in the treatment of epithelioid sarcoma and two orphan drugs in the treatment of acute...
Today, the U.S. Food and Drug Administration (FDA) approved rituximab-pvvr (Ruxience), a biosimilar to rituximab (Rituxan), for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis and microscopic polyangiitis....
The randomized, global, multicenter, open-label phase III ASCEND trial evaluated the efficacy and safety of acalabrutinib vs investigator’s choice of rituximab/idelalisib or rituximab/bendamustine in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Ghia et al presented ...
At the 24th Annual Congress of the European Hematology Association (EHA), Langerbeins et al presented findings from the phase III CLL12 trial, which evaluated whether ibrutinib prolongs event-free survival in patients with previously untreated, Binet stage A chronic lymphocytic leukemia (CLL)...
François-Xavier Mahon, MD, PhD, of the Université Bordeaux and Institut Bergonie, discusses results of the ENESTop study, which demonstrated the long-term durability and safety of treatment-free remission in chronic-phase CML after second-line nilotinib (Abstract 7005).
The phase III CLL14 trial—reported by Fischer et al at the 2019 ASCO Annual Meeting (Abstract 7502) and in The New England Journal of Medicine—found that the BCL2 inhibitor venetoclax plus the monoclonal antibody obinutuzumab prolonged progression-free survival vs obinutuzumab and...
Kerry A. Rogers, MD, of The Ohio State University, discusses a 3-year follow-up of phase Ib safety and efficacy findings with the selective BTK inhibitor acalabrutinib and the anti-CD20 monoclonal antibody obinutuzumab in patients with CLL (Abstract 7500).
William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, discusses the TRANSCEND CLL 004 trial, which studied the use of an experimental CD19-directed CAR T-cell product in heavily pretreated patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (Abstract ...
Mark J. Levis, MD, PhD, of The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, discusses the effect of gilteritinib on survival in patients with FLT3-mutated relapsed/refractory AML who have common co-mutations or a high FLT3-ITD allelic ratio, and the importance of FLT3-ITD...
On May 29, the U.S. Food and Drug Administration (FDA) approved the addition of overall survival data in the labeling for gilteritinib (Xospata), which is indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation as detected by an FDA-approved...
This week, the U.S. Food and Drug Administration granted designations in relapsed or refractory multiple myeloma, adenoid cystic carcinoma, and Kaposi sarcoma; and the FDA’s Oncologic Drugs Advisory Committee (ODAC) held votes on treatments for tenosynovial giant cell tumor and acute...
The U.S. Food and Drug Administration (FDA) has approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The approval is based on the results of the...
In the past 2 weeks, the U.S. Food and Drug Administration (FDA) accepted a new drug application and granted Priority Review for a prostate cancer treatment, granted Orphan Drug designation to a treatment for acute lymphoblastic leukemia, accepted an investigational new drug application for a...
On May 2, the U.S. Food and Drug Administration (FDA) expanded its approval of ivosidenib (Tibsovo) to include newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that ...
Over the past week, the U.S. Food and Drug Administration (FDA) granted several Fast Track and Orphan Drug designations to treatments for myelodysplastic syndromes, triple-negative breast cancer, acute myeloid leukemia (AML), and Epstein-Barr virus (EBV)-associated cancers. Fast Track Designation...
This week, the U.S. Food and Drug Administration (FDA) granted designations for treatments for recurrent glioblastoma, neurofibromatosis type 1 and plexiform neurofibromas, multiple myeloma, and relapsed or refractory FLT3-ITD acute myeloid leukemia (AML). Fast Track Designation for Ad-RTS-hIL-12...
Treatment with the FLT3-targeted therapeutic gilteritinib improved survival for patients with relapsed or refractory acute myeloid leukemia (AML) harboring an FLT3 mutation compared with standard chemotherapy regimens, according to results from the phase III ADMIRAL trial presented by Perl et al at ...
This week, the U.S. Food and Drug Administration (FDA) announced policy changes to modernize mammography policies and issued a Breakthrough Therapy designation, an Orphan Drug designation, and an investigational new drug application. FDA Advances Policy Changes to Modernize Mammography Services...
Neil P. Shah, MD, PhD, of the UCSF Helen Diller Family Comprehensive Cancer Center, discusses the feasibility of discontinuing tyrosine kinase inhibitor therapy in select patients with chronic phase chronic myeloid leukemia outside of clinical trials.
Frederick L. Locke, MD, of the H. Lee Moffitt Cancer Center and Research Institute, discusses recent approvals of chimeric antigen receptor T-cell therapies in leukemia and lymphoma, and how clinicians are using infrastructure, navigation, and early referrals to maximize response and minimize...
In the past week, the U.S. Food and Drug Administration (FDA) approved a companion diagnostic assay, granted Breakthrough Device and Breakthrough Therapy designations, and extended the review period of a proposed treatment. The agency also published four draft guidances and one final guidance...
The FDA recently issued announcements on a Fast Track designation, a Priority Review, two supplemental new drug applications, an investigational new drug application, and a marketing clearance. The agency also released a safety communication on cancer-related surgery. Fast Track Designation for...
Stefan O. Ciurea, MD, of The University of Texas MD Anderson Cancer Center, discusses the enhanced antitumor effect and lower viral reactivation that result from high doses of natural killer cells infused after haploidentical transplantation, with no excess graft-vs-host disease, a low relapse rate ...
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...
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...
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...
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...
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...
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...
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...
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 ...
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...
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...
Today, the U.S. Food and Drug Administration (FDA) approved glasdegib (Daurismo) tablets to be used in combination with low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or with comorbidities that may preclude the use of ...