Histiocytic Sarcoma

FDA-approved generic provides cost-effective option for treating cancer LAKE ZURICH, Ill.--(BUSINESS WIRE)-- Fresenius Kabi announced today it has introduced Cyclophosphamide for Injection, USP, a generic substitute for Cytoxan, for use in treating several forms of cancer. Now available in the U.S., Cyclophosphamide for Injection, USP is the newest addition to Fresenius Kabi’s broad portfolio of generic oncology injectables that help make cancer therapies more affordable and accessible. This press release features multimedia. View the full release here: Cyclophosphamide is now available from Fresenius Kabi. (Photo: Business Wire) “The introduction of Cyclophosphamide for Injection adds another critical treatment to our broad and leading oncology portfolio that offers lower-cost options for treating cancer,” said John Ducker, president and CEO of Fresenius Kabi USA. Supplied as a 500mg, 1g, and 2g single-dose vials of lyophilized powder, the drug can be administered intravenously or orally. Fresenius Kabi offers all lyophilized presentations of cyclophosphamide currently in the market. Cyclophosphamide for Injection, USP is available through distributors or direct from Fresenius Kabi. About Cyclophosphamide for Injection, USP Cyclophosphamide for Injection is an alkylating drug indicated for the treatment of: Malignant Diseases: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma Minimal Change Nephrotic Syndrome in Pediatric Patients: biopsy proven minimal change nephrotic syndrome patients who failed to adequately respond to or are unable to tolerate adrenocorticosteroid therapy Limitations of Use: The safety and effectiveness for the treatment of nephrotic syndrome in adults or other renal disease has not been established. IMPORTANT SAFETY INFORMATION Cyclophosphamide for Injection is contraindicated in patients with hypersensitivity to cyclophosphamide and with urinary outflow obstruction. Myelosuppression, Immunosuppression, Bone Marrow Failure and Infections - Severe immunosuppression may lead to serious and sometimes fatal infections. Close hematological monitoring is required. Urinary Tract and Renal Toxicity - Hemorrhagic cystitis, pyelitis, ureteritis, and hematuria can occur. Exclude or correct any urinary tract obstructions prior to treatment. Cardiotoxicity - Myocarditis, myopericarditis, pericardial effusion, arrhythmias and congestive heart failure, which may be fatal, have been reported. Monitor patients, especially those with risk factors for cardiotoxicity or pre-existing cardiac disease. Pulmonary Toxicity - Pneumonitis, pulmonary fibrosis and pulmonary veno-occlusive disease leading to respiratory failure may occur. Monitor patients for signs and symptoms of pulmonary toxicity. Secondary malignancies have been reported in patients treated with cyclophosphamide-containing regimens. Veno-occlusive Liver Disease - Fatal outcome can occur. Embryo-Fetal Toxicity - Can cause fetal harm. Advise female patients of reproductive potential to avoid pregnancy. Adverse reactions reported most often include neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, and diarrhea. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or . Nursing Mothers: Discontinue drug or nursing. Females and males of reproductive potential: Counsel patients on pregnancy prevention and planning. Renal Patients: Monitor for toxicity in patients with moderate and severe renal impairment. This Important Safety Information does not include all the information needed to use Cyclophosphamide for Injection, USP safely and effectively. Please see the full prescribing information for Cyclophosphamide for Injection, USP at . About Fresenius Kabi Fresenius Kabi ( ) is a global health care company that specializes in injectable medicines, biosimilars, clinical nutrition and technologies for infusion and transfusion. The company’s products and services are used to help care for patients with critical and chronic conditions. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at and follow us on LinkedIn and Facebook.

Published in the Journal of the American Veterinary Medical Association (JAVMA), a PetDx® study shows that the company's novel OncoK9® Screen "liquid biopsy" blood test provides high sensitivity for seven common cancer types that are often difficult to detect in dogs by physical exam alone. By integrating cell-free DNA quantification and next-generation sequencing using a proprietary method, the new test can be performed faster and at lower cost than the company's flagship OncoK9® Dx test, allowing for broader access to blood-based cancer screening in dogs. SAN DIEGO, Feb. 9, 2024 /PRNewswire/ -- PetDx® – The Liquid Biopsy Company for Pets™ published a clinical validation study this week showing that its new OncoK9® Screen test has a high detection rate across seven predefined, clinically relevant cancer types that represent a large proportion of all cancers found in dogs and are often difficult to detect by physical exam alone due to their anatomic location and/or lack of specific clinical signs. These cancer types are often aggressive, requiring prompt intervention, and have typically been associated with improved outcomes when detected and treated early. Appearing in the Journal of the American Veterinary Medical Association, the study evaluated nearly 2,000 dogs with and without cancer across independent training and testing cohorts (to mitigate the risk of data overfitting), making it by far the largest clinical validation study ever published for a cancer detection test in veterinary medicine. It demonstrated a sensitivity of over 70% for the OncoK9® Screen test across seven cancer types (lymphoma, hemangiosarcoma, osteosarcoma, leukemia, histiocytic sarcoma, primary lung tumors, and urothelial carcinoma), with a low false positive rate of <1.5% in cancer-free dogs. The OncoK9® Screen test's proprietary algorithm analyzes cell-free DNA (cfDNA) quantification data to generate a final result of High or Low Probability of Cancer for approximately 90% of samples tested; the remaining samples are automatically reflexed to additional testing by next-generation sequencing (NGS) to arrive at a final result. Dogs do not have to be fasted prior to blood collection, and samples are sent directly to the PetDx lab in specialized tubes provided by the company, without any requirements for in-clinic processing. "Previously published research has shown that only around 10% of cancer cases are currently detected in dogs prior to the onset of clinical signs. The OncoK9® Screen test can act as a complement to the physical exam to increase the number and types of cancers detectable during routine wellness visits," said Andi Flory, DVM, DACVIM (Oncology), Chief Medical Officer at PetDx and the study's lead author. "The availability of comprehensively validated blood-based cancer detection tools that can be readily incorporated into preventive care protocols opens the door to the development of cancer screening guidelines for early cancer detection in dogs." PetDx President and CEO Alejandro Bernal, DVM, MS, MBA, added that using only cfDNA quantification analysis for the vast majority of samples allows the OncoK9® Screen test to be performed at a much lower cost and with a shorter turnaround time than the company's flagship test, which is now designated as OncoK9® Dx. "The addition of OncoK9® Screen to our portfolio of non-invasive liquid biopsy tests is intended to make early cancer detection more accessible to veterinarians and pet owners and highlights the company's relentless commitment to innovation in an area of considerable unmet need in veterinary medicine," he said. About PetDx PetDx® – The Liquid Biopsy Company for Pets™ is a San Diego-based molecular diagnostics company dedicated to unleashing the power of genomics to improve pet health. The company's portfolio of "liquid biopsy" multi-cancer early detection (MCED) blood tests includes two pioneering solutions (OncoK9® Screen and OncoK9® Dx) that have been extensively validated in large clinical studies published by leading peer-reviewed journals. Both tests enable veterinarians to detect cancer in dogs with a simple blood draw. To learn more, visit PetDx.com, OncoK9.com, and connect with us on Facebook, Instagram, LinkedIn, and X. SOURCE PetDx

WALTHAM, Mass.--( BUSINESS WIRE )-- BostonGene , a leading provider of AI-driven molecular and immune profiling solutions, today announced the selection of four abstracts for oral presentation, four abstracts as poster presentations, and two abstracts for online publication at the 65 th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 9-12, 2023, in San Diego, California and virtually. BostonGene will exhibit in booth #2350. “ We look forward to showcasing compelling data at ASH, which will underscore the pivotal role of molecular and immune profiling alongside advanced analytics in propelling precision medicine for individuals battling cancer,” said Nathan Fowler, MD, Chief Medical Officer at BostonGene. Details of the presentations are below: Oral presentations: Abstract: 601 Title: Clinical Outcomes of Patients with Relapsed/Refractory Follicular Lymphoma Treated with Tisagenlecleucel: Phase 2 Elara 3-Year Follow-up Date & time: Sunday, December 10, 2023 | 4:30 PM Location: Room 6CF - San Diego Convention Center Presenter: Stephen J Schuster, MD , Abramson Cancer Center, University of Pennsylvania This presentation highlights results from the Phase 2 ELARA trial that show efficacy, safety, pharmacokinetic, and exploratory biomarker analyses in relapsed/refractory follicular lymphoma patients treated with tisagenlecleucel after a median follow-up of more than 3 years. Higher baseline levels of CD8+ naive T cells are associated with improved long-term clinical outcomes. Research conducted in collaboration with The University of Texas MD Anderson Cancer Center, Abramson Cancer Center, University of Pennsylvania, The University of Melbourne, Hospital Universitario, Oslo University Hospital, Royal Brisbane Hospital, University of Michigan, City of Hope National Medical Center, Moffitt Cancer Center, Hospices Civils de Lyon and Claude Bernard Lyon 1 University, Kyushu University Hospital, Tohoku University Graduate School of Medicine, University of Amsterdam, University of California San Francisco, University of Chicago, Royal Prince Alfred Hospital, Universidad de Sevilla, Oregon Health and Science University, University of Cologne, West German Cancer Center, University of Duisburg-Essen, IRCCS San Raffaele Scientific Institute, Hokkaido University, King’s College London, University of Kansas Medical Center, Ordensklinikum Linz Barmherzige Schwestern-Elisabethinen, Universitair Ziekenhuis Gent, University Hospital of Ulm, University of Bologna, Cambridge University, Novartis Pharmaceuticals Corporation, Novartis Pharma AG, Hôpital Saint-Louis, Ludwig-Maximilians-University Hospital Abstract: 851 Title: A CD5 Gene Signature Identifies Diffuse Large B-Cell Lymphomas Sensitive to Bruton's Tyrosine Kinase Inhibition Date & time: Monday, December 11, 2023: 3:45 PM Location: Room 6DE - San Diego Convention Center Presenter: Alan Cooper, University of Chicago This study highlights the discovery of a novel transcriptomic-based biomarker of BTK inhibitors (BTK-i) response in DLBCL patients. The biomarker, a CD5 gene signature, expands upon existing genetic DLBCL classifications by identifying DLBCL patients that can benefit from BTK-i, warranting further prospective validation in BTK-i clinical trials. Research conducted in collaboration with the University of Chicago, City of Hope National Medical Center, The University of British Colombia, Janssen Research & Development, Centre for Lymphoid Cancer Abstract: 905 Title: Machine Learning (ML)-Enabled Automation for High-Throughput Data Processing in Flow Cytometry Date & time: Monday, December 11, 2023 | 3:45 PM Location: Room 6CF - San Diego Convention Center Presenter: Anna Kamysheva, MSc, BostonGene This presentation describes BostonGene’s development of an ML-based algorithm for automated cell-type labeling that enables the detection of rare and/or new cell populations with high speed and accuracy. This algorithm is applicable in clinical settings, particularly for detecting hematological abnormalities and cancers. Abstract: 983 Title: Addition of Acalabrutinib to Lenalidomide and Rituximab Induces High Complete Response Rates in Patients with Previously Untreated Follicular Lymphoma: Results of a Phase II Study Date & time: Monday, December 11, 2023 | 5:30 PM Location: Grand Hall C - Manchester Grand Hyatt San Diego Presenter: Paolo Strati, MD, MD Anderson The study demonstrates the safety and efficacy of lenalidomide and rituximab treatment in combination with acalabrutinib in previously untreated FL patients and highlights the use of bulk RNA sequencing with deconvolution to analyze the biological effects of this treatment combination on peripheral blood immune cells. Research conducted in collaboration with The University of Texas MD Anderson Cancer Center Poster presentations: Abstract: 1676 Title: Preliminary Analysis of an Ongoing Phase II Study of Response-Adapted Therapy with Copanlisib and Rituximab for Untreated Follicular Lymphoma Date & time: Saturday, December 9, 2023 | 5:30 PM - 7:30 PM Location: Halls G-H - San Diego Convention Center Presenter: Rahul Lakhotia, MBBS, National Cancer Institute, National Institutes of Health This study describes the preliminary analysis (including safety and efficacy) of an ongoing “window of opportunity” study of copanlisib, followed by response-adapted copanlisib and rituximab in treatment-naïve patients with follicular lymphoma (FL). Gene expression profiling was used to identify high-risk patients and find a predictive signature of response to PI3K inhibitor. Research conducted in collaboration with the National Cancer Institute, National Institutes of Health and Mayo Clinic Abstract : 3644 Title: A Novel Comprehensive Tumor-Informed Plasma cfDNA Assay to Monitor Minimal Residual Disease for Hematological and Solid Malignancies Date & time: Sunday, December 10, 2023 |6:00 PM - 8:00 PM Location: Halls G-H - San Diego Convention Center Presenter: Anastasiya Yudina, MSc, BostonGene This presentation describes our cell-free DNA (cfDNA) testing platform for minimal residual disease (MRD) monitoring. It encompasses all major clinically reliable genetic hotspots events and can detect clinically relevant mutations in plasma samples before clinical manifestation. Abstract: 3001 Title: Genomic and Transcriptomic Profiles of Blastoid and Pleomorphic Mantle Cell Lymphoma Are Distinct from Classic Histology Mantle Cell Lymphoma Date & time: Sunday, December 10, 2023 |6:00 PM - 8:00 PM Location: Halls G-H - San Diego Convention Center Presenter: Preetesh Jain, MD, MBBS, PhD, DM, MD Anderson This presentation highlights the use of BostonGene’s integrated genomic and transcriptomic analysis platform to provide a comprehensive portrait of the molecular differences between blastoid and pleomorphic mantle cell lymphoma (MCL), revealing mechanistic insights that can be used for the development of more effective therapeutic strategies. Research conducted in collaboration with The University of Texas MD Anderson Cancer Center Abstract: 4872 Title: Long-Term Durable Responses in Relapsed/Refractory (r/r) ALL, DLBCL, and FL Patients Treated with Tisagenlecleucel and Its Association with Persistence of CAR T-Cells Date & time: Monday, December 11, 2023: 6:00 PM - 8:00 PM Location: Halls G-H - San Diego Convention Center Presenter: Rakesh Awasthi, PhD , Novartis Institutes for BioMedical Research This study highlights a positive association between chimeric antigen receptor (CAR) persistence in peripheral blood post tisagenlecleucel (tisa-cel) infusion and durable clinical responses across three indications. Research conducted in collaboration with Novartis Institutes for BioMedical Research, Novartis Pharmaceuticals Corporation, Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Intermountain Primary Children’s Hospital, Huntsman Cancer Institute, Spencer Fox Eccles School of Medicine at the University of Utah, Goethe University Frankfurt, University Hospital, Knight Cancer Institute, Oregon Health & Science University, Emory University School of Medicine, Medical University of Vienna, Université de Paris, Klinikum der Universität, LMU München, MD Anderson Cancer Center Online publications: Title: Test-the-Test: Clinical Utility of Comprehensive Whole Exome Sequencing and RNA-Seq for Patients with Lymphoma This study shows an acceptable turn-around-time (TAT) of 8 days for the delivery of clinical reports that include clinically relevant findings and matched clinical trials, demonstrating the feasibility of using comprehensive WES and RNA-seq molecular profiling for lymphoma patients. Research conducted in collaboration with The University of Texas MD Anderson Cancer Center Title: Molecular Findings on Plasma Cell-Free DNA Analysis Among Adults with Histiocytic Neoplasms This study describes the use of cell-free DNA (cfDNA) analysis to evaluate the molecular findings in adults with histiocytic neoplasms, highlighting cfDNA as a potential viable tool for discovering driver mutations in multiple cancers. Research conducted in collaboration with The University of Alabama, Mayo Clinic In addition to the poster presentations, the abstracts have been published online in the November supplemental issue of “ Blood .” For more information, please visit the 65th ASH Annual Meeting and Exposition website at https://www-hematology-org.libproxy1.nus.edu.sg/meetings/annual-meeting/abstracts . About BostonGene Corporation BostonGene has a mission to provide transformative, AI-integrated molecular analytics and biomarker discovery for precision matching of therapies to improve the lives of patients living with cancer and other immune-related diseases. BostonGene’s concierge-service model provides customized client solutions using a multi-omic approach prioritized for real-world impact to optimize standard-of-care therapies, accelerate research and provide cost-effective, measurable data-driven results. BostonGene’s tests reveal key drivers of each patient’s unique disease profile, including an in-depth profile of the immune microenvironment, actionable mutations, biomarkers of response to diverse therapies, and recommended therapies. Through these comprehensive analyses, BostonGene’s tests generate a personalized roadmap for therapeutic decision-making for each patient. For more information, visit BostonGene at http://www.BostonGene.com.