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Showing 601 - 650Factors Influencing Response to Pembrolizumab in Various Advanced Cancers
In an analysis from the phase Ib KEYNOTE-028 trial reported in the Journal of Clinical Oncology, Ott et al found that response to pembrolizumab across different cancers was more likely in patients with higher tumor mutational burden, T-cell–inflamed gene-expression profile, and programmed...
Welcome Questions About Cervical Cancer Treatment Options
TWO STUDIES reported in The New England Journal of Medicine1,2 showed that patients with early-stage cervical cancer had reduced disease-free and overall survival when treated with minimally invasive radical hysterectomy vs open or radical hysterectomy. The findings of these studies have been...
Comparing Survival Outcomes With Minimally Invasive and Open Surgical Approaches to Early-Stage Cervical Cancer
MINIMALLY INVASIVE radical hysterectomy for women with early-stage cervical cancer has been associated with reduced rates of disease-free and overall survival in the phase III LACC randomized noninferiority trial comparing minimally invasive and open abdominal radical hysterectomy. The results...
Pembrolizumab in Sorafenib-Pretreated Hepatocellular Carcinoma
ON NOVEMBER 9, 2018, pembrolizumab (Keytruda) was granted accelerated approval for treatment of patients with hepatocellular carcinoma previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data APPROVAL WAS BASED on durable responses in the phase II KEYNOTE-224 trial...
Venetoclax in Combination Regimens for Older Patients With AML or Those With Comorbidities Precluding Intensive Induction
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 ...
Lorlatinib in Second- or Third-Line Treatment of ALK-Positive Metastatic Non–Small Cell Lung Cancer
On November 2, 2018, lorlatinib (Lorbrena) was granted accelerated approval for the treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) whose disease has progressed on crizotinib (Xalkori) and at least one other ALK inhibitor for metastatic disease or whose disease ...
Has Scalp Cooling Reached the Level of Standard of Care?
Does evidence of the effectiveness and safety of scalp cooling to reduce hair loss among women being treated for breast cancer mean that scalp cooling is a new standard of care? “I would suggest that it is,” stated Mikel Ross, MSN, RN, AGNP-BC, of the Breast Medicine Service, Memorial Sloan...
AI Technology for Digital Breast Tomosynthesis Receives FDA Clearance for Clinical Use
A deep-learning, cancer detection software built on artificial intelligence (AI) called ProFound AI received clearance by the U.S. Food and Drug Administration (FDA) for commercial sales and clinical use in the United States. The announcement was made in a news release from iCAD, Inc., a global...
Larotrectinib for Solid Tumors With NTRK Gene Fusions
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 November 26, 2018, larotrectinib (Vitrakvi) was...
ECHELON-2: Brentuximab Vedotin Plus Chemotherapy in CD30-Positive Peripheral T-Cell Lymphoma
As reported by Horwitz et al in The Lancet, the phase III ECHELON-2 trial showed that brentuximab vedotin (Adcetris) plus cyclophosphamide, doxorubicin, and prednisone (CHP) improved progression-free and overall survival vs cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in...
RSNA 2018: Preliminary Results of Primary Cryoablation in Treating Low-Risk Breast Cancers
Cryoablation has shown early indications of effectiveness in treating women with low-risk breast cancers, according to research presented at the Annual Meeting of the Radiological Society of North America (RSNA) (Abstract SSM01-01). “If the positive preliminary findings are maintained as the ...
FDA Pipeline: New Priority Reviews, Designations, and Clearances, Plus Statements on Genetic Testing and Class Labeling
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...
Duvelisib for Relapsed or Refractory CLL/SLL and for Relapsed or Refractory Follicular 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 September 24, 2018, duvelisib (Copiktra) was granted...
Using Tumor‑Infiltrating Lymphocytes to Treat Metastatic Melanoma
STEVEN A. ROSENBERG, MD, PhD, Chief of Surgery at the National Cancer Institute (NCI), began his pioneering research in adoptive cell transfer using interleukin (IL)-2 in the mid-1970s. His IL-2 studies were among the clinical trials that led to the first U.S. Food and Drug Administration approval ...
De-escalation of Chemotherapy in Favorable-Risk Diffuse Large B-Cell Lymphoma
THE REGIMEN of four cycles of rituximab (Rituxan)/cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) plus two cycles of rituximab was noninferior to that of six cycles of R-CHOP in younger patients with favorable-risk diffuse large B-cell lymphoma (DLBCL), according to the results of...
Pembrolizumab With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC
On August 20, 2018, pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and platinum was granted regular approval as first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma...
Talazoparib for Germline BRCA-Mutated HER2-Negative Advanced Breast Cancer
On October 16, 2018, the poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib (Talzenna) was approved for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.1,2 Patients must be selected for...
Lenvatinib in Unresectable Hepatocellular Carcinoma
On August 16, 2018, lenvatinib (Lenvima) was approved for the first-line treatment of patients with unresectable hepatocellular carcinoma.1,2 Supporting Efficacy Data Approval was based on the findings of a phase III open-label noninferiority trial (REFLECT), in which 954 patients with previously...
ASH 2018: Concurrent Ibrutinib May Improve Outcomes, Reduce Toxicity of CAR T-Cell Therapy in Relapsed or Refractory CLL
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...
Iobenguane I-131 for Advanced Pheochromocytoma or Paraganglioma
ON JULY 30, 2018, the radiotherapeutic agent iobenguane I-131 (Azedra) was approved for the treatment of adult and pediatric patients (aged ≥ 12 years) with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer...
Cemiplimab-rwlc for Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
On September 28, 2018, cemiplimab-rwlc (Libtayo) was approved for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.1 Supporting Efficacy Data Approval...
Duvelisib vs Ofatumumab in Relapsed or Refractory CLL/SLL
As reported in Blood by Ian W. Flinn, MD, PhD, Director of the Lymphoma Research Program at Sarah Cannon Research Institute, and colleagues, the phase III DUO trial has shown significantly prolonged progression-free survival with the phosphoinositide 3-kinase (PI3K)-δ/γ inhibitor duvelisib...
Dacomitinib for Metastatic EGFR-Mutant NSCLC
On September 27, 2018, dacomitinib (Vizimpro) received approval for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations, as detected by a test approved by the...
Ibrutinib Plus Rituximab in Adult Patients With Waldenström’s Macroglobulinemia
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 August 27, 2018, ibrutinib (Imbruvica) was approved...
New Report Demonstrates Cost of Blood Cancer Care
The costs to treat blood cancer are higher than costs for other cancers, and the costs incurred by a patient diagnosed with a blood cancer do not return to precancer levels, according to a Milliman study commissioned by The Leukemia & Lymphoma Society (LLS). The study—The...
Venetoclax for CLL or SLL With or Without 17p Deletion After Prior Therapy
On June 8, 2018, venetoclax (Venclexta) was granted regular approval for treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.1,2 Supporting Efficacy Data APPROVAL WAS BASED on ...
Thomas J. Dougherty, PhD, Father of Photodynamic Therapy, Dies at Age 85
Thomas J. Dougherty, PhD, the developer of modern photodynamic therapy and Chief Emeritus of Roswell Park’s Photodynamic Therapy Center, died October 2, 2018, in Buffalo, New York. “He was undoubtedly the major influence in bringing [photodynamic therapy] into the realm of cancer therapy,” said...
Friends of Cancer Research Launches Tumor Mutational Burden Harmonization Project
The Friends of Cancer Research (Friends) recently announced the launch of phase II of its tumor mutational burden Harmonization Project, as the research team finalizes data collected from phase I in silico analysis. “Recent data show a role for [tumor mutational burden] in identifying patients...
Exercise Therapy for Symptom Management and Treatment in Patients With Cancer
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. Although physical activity is associated with many positive outcomes in the general population,...
Activity of Antibody-Drug Conjugate Telisotuzumab Vedotin in c-Met–Positive Advanced NSCLC
In a phase I study reported in the Journal of Clinical Oncology, Strickler et al found evidence of activity of the antibody-drug conjugate telisotuzumab vedotin in non–small cell lung cancer (NSCLC) overexpressing c-Met. The agent combines the anti–c-Met monoclonal antibody...
FDA Awards Research Grants in Development of Treatments of Rare Diseases, Cancers
The U.S. Food and Drug Administration (FDA) has announced that it has awarded 12 new clinical trial research grants totaling more than $18 million over the next 4 years to enhance the development of medical products for patients with rare diseases. These new grants were awarded to principal...
Next-Generation Sequencing: New Technology That Requires Further Thought
Next-generation sequencing is used with increasing frequency to provide essential information about a patient’s diagnosis and treatment. In recent months, the U.S. Food and Drug Administration (FDA) has approved several new next-generation sequencing diagnostic tools, and the Centers for Medicare...
FDA Approves Talazoparib for Deleterious Germline BRCA-Mutated HER2-Negative Locally Advanced or Metastatic Breast Cancer
On October 16, 2018, the U.S. Food and Drug Administration (FDA) approved talazoparib (Talzenna), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer....
Duvelisib vs Ofatumumab in Relapsed or Refractory CLL/SLL
As reported in the journal Blood by Flinn et al, the phase III DUO trial has shown significantly prolonged progression-free survival with the phosphoinositide 3-kinase (PI3K)-δ,-γ inhibitor duvelisib (Copiktra) vs ofatumumab (Arzerra) in patients with relapsed or refractory chronic...
Rucaparib for Maintenance Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
IN APRIL 2018, the poly (ADP-ribose) polymerase (PARP) inhibitor rucaparib (Rubraca) was granted approval for maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.1,2...
FDA Approves Expanded Use of Gardasil 9 to Include Individuals Aged 27 to 45
The U.S. Food and Drug Administration (FDA) has approved a supplemental application for recombinant human papillomavirus (HPV) 9-valent vaccine (Gardasil 9), expanding the approved use of the vaccine to include women and men aged 27 through 45 years. Gardasil 9 prevents certain cancers and...
Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome
On August 8, 2018, the CC chemokine receptor type 4 (CCR4)-directed monoclonal antibody mogamulizumab-kpkc (Poteligeo) was approved for adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy.1,2 Supporting Efficacy Data The current...
Bacterial Therapy Tolerable, Shows Early Activity in Patients With Advanced Solid Tumors
A phase I clinical trial investigating the use of bacterial Clostridium novyi-NT spores as an injectable monotherapy had manageable toxicities and showed early clinical efficacy in patients with treatment-refractory solid tumor malignancies, according to data presented at the CRI-CIMT-EATI-AACR...
Pertuzumab in Adjuvant Treatment of HER2-Positive Breast Cancer
AT THE END OF 2017, pertuzumab (Perjeta) was granted regular approval for use in combination with trastuzumab (Herceptin) and chemotherapy as adjuvant treatment of patients with HER2- positive early breast cancer at high risk of recurrence.1,2 Supporting Efficacy Data APPROVAL WAS BASED on...
Pembrolizumab for Advanced Cervical Cancer Progressing During or After Chemotherapy
In June 2018, pembrolizumab (Keytruda) was approved for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express programmed cell death ligand 1 (PD-L1; combined positive score [CPS] ≥ 1), as determined by a U.S....
Pembrolizumab in Relapsed or Refractory Primary Mediastinal 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 June 13, 2018, pembrolizumab (Keytruda) was granted...
Cory Wiegert Named New CEO of CancerLinQ LLC
Cory Wiegert has been named Chief Executive Officer (CEO) of CancerLinQ LLC, a wholly owned nonprofit subsidiary of ASCO. Mr. Wiegert, a proven expert in building and successfully launching innovative technology solutions, began his new role on August 13, 2018, and is overseeing the continued...
Clarifying the Complexity of Genomic Testing in Non-Hodgkin Lymphoma
AS MORE is learned about the genomic landscape in non-Hodgkin lymphoma, clinicians are grappling with how to apply this information in the clinic. At the 2018 Pan Pacific Lymphoma Conference, Andrew D. Zelenetz, MD, PhD, helped them understand this emerging area.1 Dr. Zelenetz is Professor of...
Immune Checkpoint Inhibitors in Patients With HIV-Associated Kaposi Sarcoma
Widespread use of antiretroviral therapy in the treatment of patients infected with human immunodeficiency virus (HIV) has led to a decline in the incidence of HIV-related Kaposi sarcoma, an incurable malignancy associated with HIV. Nevertheless, about 15% of these patients will go on to...
Focus on the Empire State Hematology & Oncology Society
The Empire State Hematology & Oncology Society (ESHOS), a State Affiliate of ASCO, was formed in January 2017 as a merger of three separate hematology and oncology professional organizations in New York. Stuart P. Feldman, MD, of the New York State Society of Medical Oncologists &...
Blinatumomab in Adult and Pediatric Patients With B-Cell Precursor Acute Lymphoblastic Leukemia
EARLY IN 2018, blinatumomab (Blincyto) was granted accelerated approval for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease ≥ 0.1%.1,2 Supporting Efficacy Data APPROVAL WAS...
Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia
ON JULY 20, 2018, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test.1,2 The FDA...
Daratumumab in Newly Diagnosed Transplant-Ineligible Multiple Myeloma
In May 2018, daratumumab (Darzalex) was approved for use in combination with VMP (bortezomib, melphalan, and prednisone) in the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.1 Supporting Efficacy Data Approval was based on...
Enzalutamide in Nonmetastatic Castration-Resistant Prostate Cancer
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 July 13, 2018, enzalutamide (Xtandi) was approved for...
FDA Grants Breakthrough Device Designation for Cancer Detection Liquid Biopsy
PapGene, Inc, has announced their cancer detection test has received Breakthrough Device designation from the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA). The PapGene test is a multianalyte test that uses a combination of circulating tumor DNA...
