Author: Editor

Andrew Krivoshik, MD of @AstellasUS discusses the FDA breakthrough therapy for PADCEV in combination with pembrolizumab in first-line advanced bladder cancer. ____________ – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for PADCEVTM (enfortumab vedotin-ejfv) in combination with Merck’s (known as MSD outside the United States and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.…

Andrew Krivoshik, MD of @AstellasUS discusses the FDA breakthrough therapy for PADCEV in combination with pembrolizumab in first-line advanced bladder cancer and commonly asked questions. ____________ – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for PADCEVTM (enfortumab vedotin-ejfv) in combination with Merck’s (known as MSD outside the United States and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy…

Andrew Krivoshik, MD of @AstellasUS discusses the FDA breakthrough therapy for PADCEV in combination with pembrolizumab in first-line advanced bladder cancer. ____________ – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for PADCEVTM (enfortumab vedotin-ejfv) in combination with Merck’s (known as MSD outside the United States and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.…

Breakthrough Therapy Designation Based on Initial Results from Phase 1b/2 EV-103 Clinical Trial – – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for PADCEVTM (enfortumab vedotin-ejfv) in combination with Merck’s (known as MSD outside the United States and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting. The FDA’s Breakthrough Therapy process is designed to…

Arlene Siefker-Radtke, MD of @MDAndersonNews answers the phase 1b/2 NORSE study: the importance of mutation testing.

Arlene Siefker-Radtke, MD of @MDAndersonNews answers the phase 1b/2 NORSE study: how this affects clinicians, patients and treatment today.

Arlene Siefker-Radtke, MD of @MDAndersonNews answers the phase 1b/2 NORSE study: does FGFR targeted therapy work better than an immune checkpoint inhibitor?

Arlene Siefker-Radtke, MD of @MDAndersonNews discusses the phase 1b/2 NORSE study on the treatment of metastatic urothelial carcinoma in patients with select FGFR alterations.

Nima Sharifi, MD @nimasharifimd of @CleClinicMD @ClevelandClinic discusses fundamental mechanism for other clinical outcomes and phenotypes. ___________ In a new Cleveland Clinic-led study published in JAMA Oncology, researchers show that a testosterone-related genetic variant – HSD3B1(1245C) – is associated with more aggressive disease and shorter survival in men with metastatic prostate cancer. This study – the first clinical trial validation of the relationship between HSD3B1 status and clinical outcomes – suggests that genetic testing for HSD3B1(1245C) may help physicians identify patients most likely to benefit from additional and more aggressive treatment. Nima Sharifi, M.D., of Cleveland Clinic’s Lerner Research Institute, and colleagues retrospectively analyzed data from 475…

Nima Sharifi, MD @nimasharifimd of @CleClinicMD @ClevelandClinic discusses HSD3B1(1245C) – how this affects clinicians and treatment today. _________ In a new Cleveland Clinic-led study published in JAMA Oncology, researchers show that a testosterone-related genetic variant – HSD3B1(1245C) – is associated with more aggressive disease and shorter survival in men with metastatic prostate cancer. This study – the first clinical trial validation of the relationship between HSD3B1 status and clinical outcomes – suggests that genetic testing for HSD3B1(1245C) may help physicians identify patients most likely to benefit from additional and more aggressive treatment. Nima Sharifi, M.D., of Cleveland Clinic’s Lerner Research Institute, and colleagues retrospectively analyzed data from…

Nima Sharifi, MD @nimasharifimd of @CleClinicMD @ClevelandClinic answers common questions between genetic variant and poor outcomes in men with metastatic prostate cancer; what is the frequency of this fast form of the enzyme? ______________ In a new Cleveland Clinic-led study published in JAMA Oncology, researchers show that a testosterone-related genetic variant – HSD3B1(1245C) – is associated with more aggressive disease and shorter survival in men with metastatic prostate cancer. This study – the first clinical trial validation of the relationship between HSD3B1 status and clinical outcomes – suggests that genetic testing for HSD3B1(1245C) may help physicians identify patients most likely to benefit from additional and more…

Nima Sharifi, MD @nimasharifimd of @CleClinicMD @ClevelandClinic discusses a link between genetic variant and poor outcomes in men with metastatic prostate cancer. _____________ In a new Cleveland Clinic-led study published in JAMA Oncology, researchers show that a testosterone-related genetic variant – HSD3B1(1245C) – is associated with more aggressive disease and shorter survival in men with metastatic prostate cancer. This study – the first clinical trial validation of the relationship between HSD3B1 status and clinical outcomes – suggests that genetic testing for HSD3B1(1245C) may help physicians identify patients most likely to benefit from additional and more aggressive treatment. Nima Sharifi, M.D., of Cleveland Clinic’s Lerner Research Institute, and…

Caregiving responsibilities found to negatively affect academic productivity, primarily for men Hematologists who complete a mentored training program experience greater levels of academic success than those who do not; however, a study published today in Blood Advances suggests a slight discrepancy in success levels between male and female hematologists. The study, which examined the effect of caregiving responsibilities on academic success, identified that, on average, men had one more first- or senior-authored publication than women, and almost twice as many total publications. Surprisingly, the study found that self-identification as a caregiver was associated with decreased productivity for men but not women. The American Society…

Amer Zeidan, MBBS, Associate Professor of Hematology, Yale School of Medicine @YaleCancer explains how oral therapies will impact the treatment landscape in myeloid malignancies.

Amer Zeidan, MBBS, Associate Professor of Hematology, Yale School of Medicine @YaleCancer considers what we have learned from understanding real-world evidence (RWE) in older patients with acute myeloid malignancies.

Amer Zeidan, MBBS, Associate Professor of Hematology, Yale School of Medicine @YaleCancer elaborates on the role of venetoclax in treatment of myelodysplastic syndromes (MDS).

Jasmine Zain, MD, Director of the T-cell Lymphoma Program, Department of Hematology and Hematopoietic Cell Transplantation, Toni Stephenson Lymphoma Center, City of Hope, shares outcomes from the PRIMO study investigating duvelisib in peripheral T-cell lymphoma (PTCL).

Jasmine Zain, MD, Director of the T-cell Lymphoma Program, Department of Hematology and Hematopoietic Cell Transplantation, Toni Stephenson Lymphoma Center, City of Hope, tells us about some of the novel approaches in development for the treatment of peripheral T-cell lymphoma (PTCL).

Jasmine Zain, MD, Director of the T-cell Lymphoma Program, Department of Hematology and Hematopoietic Cell Transplantation, Toni Stephenson Lymphoma Center, City of Hope, discusses the most impressive studies in the treatment of peripheral T-cell lymphoma (PTCL) presented at ASH 2019.

Jasmine Zain, MD, Director of the T-cell Lymphoma Program, Department of Hematology and Hematopoietic Cell Transplantation, Toni Stephenson Lymphoma Center, City of Hope, considers how peripheral T-cell lymphoma (PCL) therapy has evolved in recent years.

Christopher Yasenchak, MD, Willamette Valley Cancer Institute and Research Center, Associate Chair, Hematology Research, US Oncology Research, discusses the most impressive clinical presentations from ASH 2019 in the treatment of Hodgkin’s lymphoma.

Christopher Yasenchak, MD, Willamette Valley Cancer Institute and Research Center, Associate Chair, Hematology Research, US Oncology Research, tells us about the patient profile most suited for zanubrutinib in relapsed/refractory mantle cell lymphoma (MCL).

Christopher Yasenchak, MD, Willamette Valley Cancer Institute and Research Center, Associate Chair, Hematology Research, US Oncology Research, shares the design and results of the Phase 2 study investigating first-line brentuximab vedotin plus nivolumab in older patients with Hodgkin’s lymphoma.

Michael Wang, MD, Professor, Department of Lymphoma and Myeloma @MDAndersonNews offers his opinion on zanubrutinib as compared to other second-generation BTK inhibitors in the management of lymphoma.

Michael Wang, MD, Professor, Department of Lymphoma and Myeloma @MDAndersonNews offers his impression of the pivotal clinical data that lead to the FDA approval of zanubrutinib.

Michael Wang, MD, Professor, Department of Lymphoma and Myeloma @MDAndersonNews speculates on therapies for front-line and relapsed mantle cell lymphoma.

Michael Wang, MD, Professor, Department of Lymphoma and Myeloma @MDAndersonNews elaborates on the ZUMA-2 trial investigating anti-CD19 CAR-T cell therapy in mantle cell lymphoma.

Peter M. Voorhees, MD @LevineCancer shares the current thinking regarding treatment algorithms in relapsed/refractory multiple myeloma.

Peter M. Voorhees, MD @LevineCancer explains how daratumumab is changing the way multiple myeloma (MM) patients are treated today.

Peter M. Voorhees, MD @LevineCancer summarizes the design and outcomes of the Phase 2 Griffin study in newly diagnosed multiple myeloma (MM) patients.

Chaitra Ujjani, MD, Associate Professor, @SeattleCCA University of Washington, Fred Hutchinson Cancer Research Center, tells us about the results of the Phase 3 ELEVATE TN study, investigating acalabrutinib combined with obinutuzumab or alone versus obinutuzumab plus chlorambucil in patients with treatment-naive chronic lymphocytic leukemia (CLL).

Chaitra Ujjani, MD, Associate Professor, @SeattleCCA University of Washington, Fred Hutchinson Cancer Research Center, considers the ideal patient profile for zanubrutinib in relapsed/refractory mantle cell lymphoma (RR-MCL).

Chaitra Ujjani, MD, Associate Professor, @SeattleCCA University of Washington, Fred Hutchinson Cancer Research Center, offers her impression of the Phase 2 CAPTIVATE study investigating the BTK inhibitor ibrutinib plus venetoclax in the first-line treatment of chronic lymphocytic leukemia (CLL).

Chaitra Ujjani, MD, Associate Professor, @SeattleCCA University of Washington, Fred Hutchinson Cancer Research Center, offers opinion on how physicians should be thinking about the use of BTK inhibitors in the treatment of chronic lymphocytic leukemia (CLL).

Chaitra Ujjani, MD, Associate Professor, @SeattleCCA University of Washington, Fred Hutchinson Cancer Research Center, tells us about Veneto-STOP study presented at ASH 2019.

Constantine Tam, MBBS, MD, Consultant Hematologist, Peter MacCallum Cancer Center, Melbourne, Australia, regarding the ideal patient profile in relapsed or refractory mantle cell lymphoma (MCL) for treatment with zanubrutinib.

Constantine Tam, MBBS, MD, Consultant Hematologist, Peter MacCallum Cancer Center, Melbourne, Australia, offers his impression of the pivotal clinical data that lead to the recent FDA approval of zanubrutinib.

Max Topp, MD, Professor and Head of Hematology, University Hospital of Wuerzburg Germany, on the development of a new risk management plan to potentially reduce the toxicity of CAR-T cell therapy.

Max Topp, MD, Professor and Head of Hematology, University Hospital of Wuerzburg Germany, shares the long-term results of the ZUMA-1 trial presented at ASH 2019.

– ALUNBRIG has Potential to Expand its Indication in ALK+ Metastatic Non-Small Cell Lung Cancer – – Prescription Drug User Fee Act (PDUFA) Target Action Date Set for June 23, 2020 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s supplemental New Drug Application (sNDA) to expand the use of ALUNBRIG (brigatinib) as a first-line treatment for patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. ALUNBRIG is a next-generation tyrosine kinase inhibitor (TKI) that was designed to target…

 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, today announced its plan to initiate a Phase 1/2 study evaluating a triple combination of Compugen’s COM701, an investigational anti-PVRIG antibody, in combination with Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor Opdivo® (nivolumab) and BMS-986207, Bristol-Myers Squibb’s investigational anti-TIGIT antibody. The triple combination study is designed to evaluate the blockade of the three immune checkpoint pathways – PVRIG, TIGIT and PD-1, and will accelerate the clinical evaluation of Compugen’s science-driven DNAM axis hypothesis in various advanced solid tumors. The study is expected to commence in the second half of 2020, following…

Constantine Tam, MBBS, MD, Consultant Hematologist, Peter MacCallum Cancer Center, offers his impression of the pivotal clinical data that lead to the recent FDA approval of zanubrutinib.

Constantine Tam, MBBS, MD, Consultant Hematologist, Peter MacCallum Cancer Center, offers his impressions of the Phase 2 CAPTIVATE study investigating the BTK inhibitor ibrutinib plus venetoclax in the 1st line treatment of chronic lymphocytic leukemia (CLL).

Richard Stone, MD, Physician, Hematologic Oncology, Internal Medicine, @DanaFarber shares thoughts on current treatment strategies for elderly acute myeloid leukemia (AML) patients.

Richard Stone, MD, Physician, Hematologic Oncology, Internal Medicine, @DanaFarber elaborates on prognostic factors and the relationship to outcomes in acute myeloid leukemia (AML) patients.

Richard Stone, MD, Physician, Hematologic Oncology, Internal Medicine, @DanaFarber offers his impression of the landscape for FLT3 inhibition in acute myeloid leukemia (AML).

Richard Stone, MD, Physician, Hematologic Oncology, Internal Medicine, @DanaFarber provides opinion on whether all acute myeloid leukemia (AML) patients should be tested for FLT3 mutations.

Richard Stone, MD, Physician, Hematologic Oncology, Internal Medicine, @DanaFarber describes the landscape of mutations and targeted therapy in acute myeloid leukemia (AML).

Catherine Smith, MD, Assistant Professor, Division of Hematology/Oncology, Department of Medicine, @UCSFCancer discusses the prognostic factors in acute myeloid leukemia (AML) and how these factors relate to outcomes for patients.

Catherine Smith, MD, Assistant Professor, Division of Hematology/Oncology, Department of Medicine, @UCSFCancer offers her overall impression on the changing FLT3 inhibition landscape in acute myeloid leukemia (AML).