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Showing 851 - 900FDA Pipeline: What’s New in Biosimilars, Drug Reviews, Designations, and More
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Approval for Pegfilgrastim Biosimilar The FDA recently approved a pegfilgrastim biosimilar, pegfilgrastim-cbqv (Udenyca). The biosimilar has been approved to decrease the incidence...
Alan D. D’Andrea, MD, and Neal S. Young, MD, to Present 2018 ASH Ernest Beutler Lecture
THE AMERICAN SOCIETY of Hematology (ASH) will honor Alan D. D’Andrea, MD, of Harvard Medical School and Dana-Farber Cancer Institute, and Neal S. Young, MD, of the National Heart, Lung, and Blood Institute of the National Institutes of Health, with the 2018 Ernest Beutler Lecture and Prize for...
Connie J. Eaves, PhD, FRS, to Give Honorary Lecture at 2018 ASH Annual Meeting
The American Society of Hematology (ASH) will honor Connie J. Eaves, PhD, FRS, of BC Cancer at the University of British Columbia, with the 2018 E. Donnall Thomas Lecture and Prize for her contributions to the field of hematopoiesis and stem cell research. Dr. Eaves will present her lecture,...
ASH Honors John E. Dick, PhD, and Reed E. Drews, MD, With 2018 Mentor Award
The American Society of Hematology (ASH) will recognize John E. Dick, PhD, of the University of Toronto, Princess Margaret Cancer Center, and Ontario Institute for Cancer Research in Toronto, and Reed E. Drews, MD, of Beth Israel Deaconess Medical Center in Boston, with the 2018 Mentor Award for...
ASH Honors Victor Hoffbrand, DM, FRCP, FMed Sci, With Lifetime Achievement Award
The American Society of Hematology (ASH) will recognize Victor Hoffbrand, DM, FRCP, FMed Sci, of the University College London, with the 2018 Wallace H. Coulter Award for Lifetime Achievement in Hematology, the Society’s highest honor. Dr. Hoffbrand will be recognized for his contributions to...
Humbled by Challenges, Renowned Hematologist Kanti R. Rai, MD, Recalls a Rich Career
For this installment of the Living a Full Life series, guest editor, Jame Abraham, MD, interviewed Kanti R. Rai, MD, Professor of Medicine at the Karches Center for Oncology Research, Feinstein Institute for Medical Research, Manhasset; Professor of Medicine at Zucker School of Medicine at...
Nancy Berliner, MD, Named Next Editor-in-Chief of Blood
The American Society of Hematology (ASH) has selected Nancy Berliner, MD, the H. Franklin Bunn Professor of Medicine and Chief of Hematology at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School, as the next Editor-in-Chief of its journal Blood. Dr. Berliner was...
Novel Treatment Approaches in Early Relapse of Follicular Lymphoma
“Patients with follicular lymphoma who relapse early after treatment are a minority of patients, fortunately, but they are clearly patients with a different disease,” according to Jonathon B. Cohen, MD, of Emory University School of Medicine. At Emory’s 2018 Debates and Didactics in Hematology and...
Current Treatment Landscape of Relapsed or Refractory Chronic Lymphocytic Leukemia
Novel agents such as ibrutinib (Imbruvica), idelalisib (Zydelig), and venetoclax (Venclexta) have transformed the treatment of chronic lymphocytic leukemia (CLL) and are increasingly used to treat the disease. The optimal sequencing of these agents is not clear in relapsed or refractory disease,...
ASCP, CAP, and ASH Invite Public Comment on Lymphoma Guideline
With a focus on the pathology aspects of diagnosing lymphoma, the American Society for Clinical Pathology (ASCP), the College of American Pathologists (CAP), and the American Society of Hematology (ASH) are collaborating to develop an evidence-based clinical practice guideline for the workup of...
Emerging Options and Sequencing Therapy in Relapsed Multiple Myeloma
Advances in the treatment of multiple myeloma have led to longer progression-free survival, but the majority of patients will still relapse despite newer treatments. A number of new drugs and combinations are under study in the hope of improving outcomes. “Multiple myeloma is a complex disease...
The Relevance of the RELEVANCE Trial in Follicular Lymphoma
We have seen remarkable progress in the outcomes of patients with advanced-stage follicular lymphoma over the past 2 decades.1 Recent manuscripts and presentations describing long-term follow-up of randomized trials comparing various chemotherapy platforms (all combined with anti-CD20 antibodies)...
ASH Honors Ross L. Levine, MD, With 2018 William Dameshek Prize
The American Society of Hematology (ASH) will present the 2018 William Dameshek Prize to Ross L. Levine, MD, of Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, for his discoveries in the field of leukemia and myeloproliferative neoplasms during the 2018 ASH Annual Meeting ...
ctDNA and Treatment Outcome in Diffuse Large B-Cell Lymphoma
In a study reported in the Journal of Clinical Oncology, Kurtz et al found that baseline circulating tumor DNA (ctDNA) and molecular response to treatment were independent predictors of treatment outcome in diffuse large B-cell lymphoma. Study Details The association of ctDNA with treatment...
Venetoclax and Beyond: Successfully Targeting BCL2
Although many agents have been able to successfully inhibit the proliferative capacity of cancer cells or disable mutations that spur cancer growth, one area that has proven elusive is the apoptotic pathway—the cell’s means of resisting death. That is until recently. Dysregulation of B-cell...
For Hodgkin Lymphoma, PD-1 Blockade Is Not the Final Answer
Although programmed cell death protein 1 (PD-1) blockade is highly effective in Hodgkin lymphoma, not all patients respond, and not all responses are durable. Stephen M. Ansell, MD, PhD, Chair of the Mayo Clinic Lymphoma Group and Professor of Medicine at the Mayo Clinic, Rochester, described...
More Antibody-Drug Conjugates Expected to Impact Treatment of Lymphoma
FOR THE TREATMENT of lymphoma, antibody-drug conjugates (ADCs) are becoming an important class of drugs, as described at the 2018 Pan Pacific Lymphoma Conference by Brad Kahl, MD, Professor of Medicine at Washington University School of Medicine, St. Louis.1 “We have one ADC—brentuximab vedotin...
CAR T-Cell Therapy in Lymphoma: Challenges Come With Success
THE EMERGENCE of chimeric antigen receptor (CAR) T-cell therapy has sparked a wave of optimism in hematologic malignancies, but as experience in using CAR T-cell therapy has grown, new challenges have surfaced. A pioneer in the field, David G. Maloney, MD, PhD, enlightened attendees on these issues ...
New Frontiers Being Explored in Multiple Myeloma
BEFORE TOO LONG, oncologists can expect to have an entirely new arsenal in the fight against multiple myeloma. Cutting-edge therapies on the near horizon were described in a presentation by Kenneth Anderson, MD, at the 2018 American Association of Cancer Research’s (AACR’s) inaugural conference on...
Expert Point of View: Susan O'Brien, MD, and Bruce Cheson, MD
SUSAN O’BRIEN, MD, Associate Director for Clinical Science, Chao Family Comprehensive Cancer Center, University of California Irvine Health, told The ASCO Post that the pairing of ibrutinib (Imbruvica) and venetoclax (Venclexta) “is clearly a very powerful combination.” The next question, she...
Tisagenlecleucel for Adults With Relapsed or Refractory Large B-Cell Lymphoma
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 May 1, 2018, tisagenlecleucel (Kymriah), a...
Weighing the Cost and Value of CAR T-Cell Therapy
This past year’s approval by the U.S. Food and Drug Administration (FDA) of two chimeric antigen receptor (CAR) T-cell therapies heralded a new era in both effective cancer treatments and the most expensive cancer drugs ever. Tisagenlecleucel (Kymriah) was initially approved for the treatment of...
FDA Expands Tisagenlecleucel Approval to Include Relapsed or Refractory Large B-Cell Lymphoma
On May 1, 2018, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah) for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade...
Planning for Potential Adverse Effects of Oral Chemotherapy
THE USE OF oral chemotherapy drugs is becoming more and more prevalent—for many types and stages of cancer, during different treatment phases, and for varying lengths of time. So it’s vital that physicians, nurses, and advanced practitioners understand all the potential adverse events of these...
Hematology Fellows and Junior Faculty Participate in 2018 ASH Clinical Research Training Institute in Latin America
This week, the American Society of Hematology (ASH) announced the names of the 35 hematologists participating in the 2018 ASH Clinical Research Training Institute in Latin America (CRTI-LA) and Advanced CRTI-LA. This education and mentorship program was held April 23–26, prior to the...
Axicabtagene Ciloleucel CAR T-Cell Therapy Active in Refractory Large B-Cell Lymphoma
As reported at the 2017 American Society of Hematology (ASH) Meeting & Exposition and in The New England Journal of Medicine by Sattva S. Neelapu, MD, of The University of Texas MD Anderson Cancer Center, and colleagues, a phase II trial has shown high activity of autologous anti-CD19 chimeric...
Fine-Tuning Treatment in Myeloma and Leukemia
It is a difficult task to include every notable presentation from the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition. In addition to our more comprehensive coverage of the news from that meeting over the past several issues, below are summaries of additional key...
Is CAR T-Cell Therapy Setting a New Standard of Care in Lymphoma?
Data presented at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition on the longer-term follow-up analysis of results from the ZUMA-1 trial investigating the effectiveness of axicabtagene ciloleucel (Yescarta) in patients with refractory non-Hodgkin lymphoma (NHL) showed...
FDA Expands Approval of Brentuximab Vedotin in Classical Hodgkin Lymphoma
ON MARCH 20, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (Adcetris), an antibody-drug conjugate, to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy. Brentuximab vedotin combines an antibody and...
EXPERT POINT OF VIEW: Kenneth C. Anderson, MD, and S. Vincent Rajkumar, MD
AT A PREMEETING webinar, American Society of Hematology then President Kenneth C. Anderson, MD, Director of the Lebow Institute for Myeloma Therapeutics and Jerome Lipper Myeloma Center at Dana-Farber Cancer Institute, Boston, commented: “This study demonstrates this new treatment has good...
Unique CAR T-Cell Construct Studied in Multiple Myeloma
CD19-DIRECTED chimeric antigen receptor (CAR) T-cell therapy has been approved by the U.S. Food and Drug Administration for the treatment of leukemia (tisagenlecleucel [Kymriah]) and lymphoma (axicabtagene ciloleucel [Yescarta]), but another type of CAR T-cell therapy is generating interest as a...
EXPERT POINT OF VIEW: Andrzej Jakubowiak, MD, PhD
INTERVIEWED BY The ASCO Post, Andrzej Jakubowiak, MD, PhD, Director of the Multiple Myeloma Program at the University of Chicago Medical Center, commented on the “controversial findings” of EMN02/HO95. “This European study has opened the gate toward showing the benefit of a second transplant,...
European Study Shows Double Transplant Improves Survival in Myeloma
FOR NEWLY DIAGNOSED patients with multiple myeloma considered to be at high risk of disease progression, double autologous stem cell transplantation (ASCT) significantly prolongs progression-free and overall survival, vs single transplant, according to the phase III EMN02/HO95 study. The findings...
Data Favoring Maintenance Therapy in Older Patients With AML Accumulate
The use of maintenance therapy in older patients with acute myeloid leukemia (AML) is theoretically sensible, but its clinical value remains uncertain. The phase III HOVON97 randomized study demonstrated that maintenance therapy with the hypomethylating agent azacitidine may improve disease-free...
Study Findings on Novel Agents in Neoplastic Hematology
HERE IS AN UPDATE on four different studies featured at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition. Topics focus on advanced systemic mastocytosis, diffuse large B-cell lymphoma (DLBCL), amyloidosis, and myeloproliferative neoplasms. Systemic Mastocytosis...
FDA Accepts NDA, Grants Priority Review for Ivosidenib in Relapsed or Refractory IDH1-Mutated AML
On February 15, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for ivosidenib (AG-120) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH1) mutation. The NDA was granted Priority Review...
EXPERT POINT OF VIEW: Robert Brodsky, MD
“THE RESULTS of these two trials are more similar than different. I think the best conclusion would be that we now have two trials with consistent results and can probably, in most cases, replace low–molecular-weight heparin with direct oral anticoagulants,” said Dr. Raskob, lead investigator of...
Use of Direct Oral Anticoagulants in Preventing VTE in Patients With Cancer
THE FIRST TWO randomized trials to directly compare direct oral anticoagulants vs low–molecular-weight heparin for management of venous thromboembolism (VTE) in patients with cancer suggest that direct oral anticoagulants may become the new standard of care.1,2 Direct oral anticoagulants appear to...
Releasing Follicular Lymphoma From the Curse of Frankenstein
In the December 10, 2017, issue of The ASCO Post, I authored an article in which I raised the possibility of curing follicular lymphoma without the dreaded chemotherapy. Clearly, no good deed goes unpunished: My good friend and The ASCO Post’s editor Jim Armitage, MD, challenged me to defend that...
EXPERT POINT OF VIEW: Neil P. Shah, MD, PhD; Joseph M. Connors, MD; and Kenneth C. Anderson, MD
NEIL P. SHAH, MD, PhD, Leader of the Hematopoietic Malignancies Program at the University of California, San Francisco, Helen Diller Family Cancer Comprehensive Cancer Center, noted that BLU- 285 could fill an “unmet medical need” for a KIT inhibitor that is “both potent and selective.” He pointed ...
Novel Agent Appears Active in Advanced or Aggressive Systemic Mastocytosis
THE INVESTIGATIONAL agent BLU-285 (avapritinib) has shown significant activity in patients with advanced or aggressive forms of systemic mastocytosis, a rare blood disorder that originates in mast cells, according to the findings of a phase I trial reported at the 2017 American Society of...
EXPERT POINT OF VIEW: Dan Vogl, MD
SESSION MODERATOR Dan Vogl, MD, Assistant Professor of Medicine at the University of Pennsylvania, Philadelphia, told The ASCO Post that the results with 11-1F4 were “very impressive” adding “everyone is excited” about the investigational amyloid-targeting monoclonal antibodies. “These drugs don’t ...
Amyloid-Targeting Antibody Elicits Organ Responses in Patients With Amyloidosis
IN PREVIOUSLY treated patients with amyloid light-chain (AL) amyloidosis, the chimeric fibril-reactive monoclonal antibody 11-1F4 (CAEL-101) produced organ responses in about two-thirds of patients in a phase Ia/b trial reported at the 2017 American Society of Hematology (ASH) Annual Meeting &...
EXPERT POINT OF VIEW: Dan Vogl, MD
MYELOMA SPECIALIST Dan Vogl, MD, Assistant Professor of Medicine at the University of Pennsylvania, Philadelphia, told The ASCO Post that the potential use of daratumumab (Darzalex) in amyloid light-chain amyloidosis is “exciting.” The drug could answer an unmet need in relapsed disease and become ...
Daratumumab Shows Efficacy in Amyloid Light-Chain Amyloidosis
DARATUMUMAB (DARZALEX) may be an effective treatment for systemic amyloid light-chain (AL) amyloidosis, according to phase II studies reported at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition.1,2 While the cohorts were small and the arms uncontrolled, the findings...
EXPERT POINT OF VIEW: Ken Shain, MD
KEN SHAIN, MD, Assistant Member of the Department of Malignant Hematology and Tumor Biology, Moffitt Cancer Center in Tampa, Florida, and Scientific Director of the Moffitt Myeloma Working Group, moderated the session where the study was presented and offered comments to The ASCO Post. “Professor...
For Patients Treated for Myeloma, Antibiotic Prophylaxis May Reduce Infections and Deaths
IN PATIENTS undergoing treatment of multiple myeloma, the prophylactic use of levofloxacin significantly reduced febrile episodes and deaths, without increasing healthcare-associated infections or carriage of key nosocomial pathogens, in a large multicenter study from the United Kingdom.1 The...
Alexis A. Thompson, MD, MPH, Appointed 2018 ASH President
Alexis A. Thompson, MD, MPH, an expert in sickle cell disease and thalassemia, will serve as President of the American Society of Hematology (ASH) for a 1-year term through December 2018. Dr. Thompson is Head of the Hematology Section of the Division of Hematology Oncology Transplantation and...
FDA Grants Priority Review for Daratumumab in Front-Line Multiple Myeloma Setting
On January 19, the U.S. Food and Drug Administration (FDA) granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone for the treatment of patients with newly diagnosed...
Expert Point of View: Robert Brodsky, MD and Henry Fung, MD, FACP, FRCPE
“Several new drugs that have been approved for the treatment of chronic lymphocytic leukemia (CLL) are changing the landscape of this disease. CLL is associated with a long survival, so we will need longer follow-up to see how deep the responses are,” said Robert Brodsky, MD, Director of...
