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Showing 651 - 700FDA Grants 510(k) Clearance to SRT-100+ Superficial Radiation Therapy for Treating Nonmelanoma Skin Cancer and Keloids
Sensus Healthcare, Inc, a medical device company specializing in the noninvasive treatment of nonmelanoma skin cancers and keloids with image-guided superficial radiation therapy, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new...
Encorafenib Plus Binimetinib in Unresectable or Metastatic Melanoma With BRAF Mutations
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. This past June, encorafenib (Braftovi) and binimetinib...
Long-Term Pooled Safety Data for Palbociclib Combined With Endocrine Therapy in HR-Positive, HER2-Negative Breast Cancer
In an analysis of pooled safety data from the PALOMA trials of palbociclib (Ibrance) plus endocrine therapy in hormone receptor (HR)-positive, HER2-negative advanced breast cancer reported in the Journal of the National Cancer Institute, Diéras et al found no evidence of specific cumulative...
Novel Therapy Reduces Duration of Chemoradiotherapy-Induced Mucositis in Patients With Head and Neck Cancer
GC4419, A SMALL molecule superoxide dismutase mimetic, reduced the duration, incidence, and severity of chemoradiotherapy-induced mucositis in patients with locally advanced head and neck cancer, with a safety profile comparable to that of placebo. This finding comes from a randomized phase IIb...
FDA Approves Iobenguane I-131 for Rare Adrenal Gland Tumors
On July 30, the U.S. Food and Drug Administration (FDA) approved iobenguane I-131 (Azedra) injection for adult and pediatric patients (12 years and older) with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic...
Ability of Assay to Predict Response to Immunotherapy in Patients With Advanced Gastric Cancer
Researchers from Samsung Medical Center and Guardant Health, Inc have demonstrated the feasibility of determining a measure analogous to tumor mutation burden, a promising biomarker that may predict patient response to certain immunotherapies, utilizing the Guardant360 assay, a...
Bevacizumab Plus Chemotherapy in Advanced Ovarian Cancer
ON JUNE 13, 2018, bevacizumab (Avastin) was granted approval for treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection1,2. The...
ASCO, Conquer Cancer Congratulate 2018 Grant and Award Recipients
ASCO’s Conquer Cancer Foundation presented more than $7.3 million in grants and awards to exceptional oncology researchers at the 2018 ASCO Annual Meeting. ASCO and Conquer Cancer congratulate the recipients and offer their profound thanks to those who generously supported these awards. Visit...
Acupressure for Cancer-Related Fatigue
Difficult-to-treat, cancer-related fatigue is a common, distressing clinical issue. It impedes daily activities, severely affecting patients’ quality of life. Compounding the problem is a lack of consensus on an effective pharmacologic intervention. Acupressure is a traditional Chinese medicine...
FDA Approves Ivosidenib for IDH1-Mutated AML
Today, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (isocitrate dehydrogenase-1 [IDH1]...
Prostate-Specific Membrane Antigen–Targeted Docetaxel Nanoparticle in Metastatic Castration-Resistant Prostate Cancer
In a phase II trial reported in JAMA Oncology, Autio et al found that prostate-specific membrane antigen (PSMA)–targeted docetaxel nanoparticle (BIND-014) treatment was active in patients with metastatic castration-resistant prostate cancer (mCRPC). Study Details In the multicenter trial,...
A. Oliver Sartor, MD, on Issues in Immunotherapy
A. Oliver Sartor, MD, of Tulane University, speaks anecdotally about immunotherapy for prostate cancer and shares his experiences in speaking to patients with late-stage disease about the knowns, unknowns, risks, and toxicities of using a therapy outside the context of a clinical trial setting. The ...
Owen A. O’Connor, MD, PhD, on Issues in Immunotherapy
Owen A. O'Connor, MD, PhD, of Columbia University Medical Center, shares his perspective on immunotherapy for patients with late-stage cancer in the context of a clinical trial setting and recent Right-to-Try legislation. The content in this post has not been reviewed by the American Society of...
Andrew D. Seidman, MD, on Embracing Computer-Assisted Decision-Making
Andrew D. Seidman, MD, of Memorial Sloan Kettering Cancer Center, discusses the benefits of decision support tools, especially for the oncologist who treats a variety of cancers in his or her practice. The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. ...
Allen S. Lichter, MD, and Mark J. Ratain, MD, on Better Dosing, Lower Cost: Improving Cancer Care and Value
Allen S. Lichter, MD, Board Chair of the Value in Cancer Care Consortium, and Mark J. Ratain, MD, of the University of Chicago, discuss the benefits—and challenges—of lowering dosages in the face of market forces. The content in this post has not been reviewed by the American Society of Clinical...
Pooled Study Analysis Explores the Use of CDK4/6 Inhibitors in Metastatic Breast Cancer
RESEARCH TO DATE has not been able to identify a subgroup of patients with estrogen receptor–positive HER2-negative metastatic breast cancer who do not derive benefit from the addition of inhibitors of cyclin-dependent kinases 4/6 (CDK4/6) to endocrine therapy, according to a study by the U.S. Food ...
Once- vs Twice-Weekly Carfilzomib in Relapsed or Refractory Multiple Myeloma
An interim analysis of the phase III ARROW trial reported in The Lancet Oncology by Moreau et al indicated that a higher-dose once-weekly schedule of carfilzomib was associated with prolonged progression-free survival vs a twice-weekly schedule in patients with relapsed or refractory multiple...
KEYNOTE-224: Pembrolizumab in Advanced Hepatocellular Carcinoma Pretreated With Sorafenib
As reported in The Lancet Oncology by Zhu et al, the phase II KEYNOTE-224 study has shown activity of pembrolizumab in advanced hepatocellular carcinoma (HCC) pretreated with sorafenib. Study Details In the study, 104 eligible patients who were intolerant of or progressed on sorafenib were...
Automated Bone Scan Index and Overall Survival in Metastatic Castration-Resistant Prostate Cancer
In a secondary analysis of the phase III 10TASQ10 trial comparing tasquinimod vs placebo in chemotherapy-naive metastatic castration-resistant prostate cancer, the automated Bone Scan Index (aBSI) was shown to be predictive of overall survival. The findings were reported in JAMA Oncology by...
‘Pearls of Wisdom’ for Leadership and Success in Academic Medicine Gathered Over a 35-Year Career
Dr. Hayes, ASCO President 2016–2017, is Professor of Internal Medicine; Stuart B. Padnos Professor in Breast Cancer; and Clinical Director of the Breast Oncology Program at the University of Michigan Comprehensive Cancer Center, Ann Arbor. AS I COMPLETE my 3-year term as ASCO President, I am...
Hematopoietic Cell Transplantation for Follicular Lymphoma
Many patients with follicular lymphoma relapse within 2 years of initial therapy, and for a number of these individuals, hematopoietic cell transplantation is a good treatment option. Transplant, however, both autologous and allogeneic, is vastly underutilized in these patients, according to Mehdi ...
2018 ASCO: Blood Test Shows Potential as a Detection Tool for Early-Stage Lung Cancer
An initial report from the large, ongoing Circulating Cell-Free Genome Atlas (CCGA) study provides preliminary evidence that a blood test may be able to detect early-stage lung cancer. This is one of the first studies to explore blood tests analyzing free-floating or cell-free DNA as a tool for the ...
Conquer Cancer 2018 Awards Presented at ASCO Annual Meeting
The Conquer Cancer Foundation of the ASCO recently announced the recipients of its 2018 ASCO Annual Meeting Merit Awards, Medical Student Rotations for Underrepresented Populations (MSR), Resident Travel Awards for Underrepresented Populations (RTA), and Long-term International Fellowship (LIFe)....
Logistics of CAR T-Cell Therapy in Real-World Practice
With the U.S. Food and Drug Administration (FDA) approvals of tisagenlecleucel (Kymriah)1 and axicabtagene ciloleucel (Yescarta),2 chimeric antigen receptor (CAR) T-cell therapy has moved into real-world practice, offering new potentially curative options for incurable hematologic malignancies. Its ...
ASCO Honors Leaders in Cancer Care With 2018 Special Awards
ASCO AND ASCO’s Conquer Cancer Foundation recognized winners of ASCO’s 2018 Special Awards and Conquer Cancer’s Women Who Conquer Cancer Mentorship Awards during the 2018 ASCO Annual Meeting, June 1 to June 4, in Chicago. The recipients of these awards included researchers, patient advocates, and...
Treatment Centers Authorized to Administer CAR T-Cell Therapy
The following medical facilities are certified, as of March 2020, to administer the U. S. Food and Drug Administration-approved chimeric antigen receptor (CAR) T-cell therapy: axicabtagene ciloleucel (Yescarta or “A”) for eligible patients with non-Hodgkin lymphoma, and tisagenlecleucel (Kymriah or ...
FDA Approves First Epoetin Alfa Biosimilar for the Treatment of Anemia
On May 15, the U.S. Food and Drug Administration (FDA) approved epoetin alfa-epbx (Retacrit) as a biosimilar to epoetin alfa (Epogen/Procrit) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Epoetin alfa-epbx is also...
Afatinib in Previously Untreated Metastatic NSCLC With Nonresistant EGFR Mutations
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 January 12, 2018, afatinib (Gilotrif) was approved...
Update Regarding Tazemetostat Clinical Program
On April 23, Epizyme, Inc, announced that U.S.-based enrollment of new patients into tazemetostat clinical trials is temporarily on hold. Following a safety report of a pediatric patient who developed a secondary lymphoma, the U.S. Food and Drug Administration (FDA) issued a partial clinical hold...
CB-839 in Combination With Cabozantinib for Advanced RCC Granted FDA Fast Track Designation
On April 18, Calithera Biosciences, Inc, announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to CB-839 in combination with cabozantinib (Cabometyx) for the treatment of patients with metastatic renal cell carcinoma (RCC) who have received one or two prior lines ...
ASCO Honors Leaders in Cancer Care With 2018 Special Awards
ASCO and ASCO’s Conquer Cancer Foundation are proud to recognize the winners of ASCO’s Special Awards and Conquer Cancer’s Women Who Conquer Cancer Mentorship Awards. The recipients of these awards include researchers, patient advocates, and global oncology leaders who have worked to transform...
A Clinician’s Guide to Treating Patients With Glioblastoma
Glioblastoma, a grade 4 astrocytoma, is the most common and most aggressive form of primary brain tumors in adults. The most recent guidance on molecular profiling, diagnostic and prognostic factors, and treatments for newly diagnosed and recurrent diseases was described in the Journal of Oncology ...
Health-Related Quality-of-Life Analysis of Anti–PD-1 Therapy vs Chemotherapy in Advanced Urothelial Cancer
As reported by Vaughn et al in the Journal of Clinical Oncology, a health-related quality-of-life analysis from the phase III KEYNOTE-045 trial in previously treated advanced urothelial cancer showed that patients treated with the anti–programmed cell death protein 1 immunotherapy...
Tivantinib in Second-Line Treatment of MET-High Advanced Hepatocellular Carcinoma
In the phase III METIV-HCC trial reported in The Lancet Oncology, Rimassa et al found no improvement in overall survival with the investigational MET inhibitor tivantinib vs placebo in patients with advanced hepatocellular carcinoma with high MET expression previously treated with sorafenib...
AACR 2018: Off-the-Shelf, Dual-Targeted CAR T-Cell Product Showed Promising Results in Preclinical Studies
FT819—an off-the-shelf, T-cell receptor–less CD19 chimeric antigen receptor (CAR) T-cell product that could potentially be made more accessible to patients with cancer than conventional CAR T-cell therapies—showed positive results in preclinical specificity, functionality, and...
Clinical Hold Lifted on U.S. Studies of BPX-501
On April 11, Bellicum Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on studies of BPX-501 in the U.S. The decision follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring...
Larotrectinib in Pediatric Solid Tumors With TRK Gene Fusions
As reported in The Lancet Oncology by Laetsch et al, phase I results from an ongoing phase I/II trial have shown activity of the TRK kinase inhibitor larotrectinib in pediatric patients with solid tumors harboring TRK fusions. Study Details In the study, 24 patients in a dose-escalation cohort...
FDA and EMA Accept Regulatory Submissions for Dacomitinib in Metastatic NSCLC With EGFR-Activating Mutations
On April 4, Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) accepted the company’s new drug application and granted Priority Review for dacomitinib, a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for the first-line treatment of...
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...
First-Line Avelumab in Metastatic Merkel Cell Carcinoma
In a preplanned interim analysis of a phase II trial (JAVELIN Merkel 200 part B) reported in JAMA Oncology, D’Angelo et al found that avelumab was active in the first-line treatment of metastatic Merkel cell carcinoma. Avelumab was approved in March 2017 for treatment of patients aged ≥ 12 ...
Comprehensive Genomic-Profiling Assay FoundationOne CDx Is Commercially Available
On March 30, Foundation Medicine announced that FoundationOne CDx, the first U.S. Food and Drug Administration (FDA)-approved comprehensive genomic-profiling assay for all solid tumors incorporating multiple companion diagnostics, is now available in the United States. FoundationOne CDx is a...
More on the ABCSG-16 Trial
Postmenopausal women with hormone receptor–positive breast cancer who took the aromatase inhibitor anastrozole for 2 years after an initial 5 years of adjuvant endocrine therapy received an equal benefit to those who took the drug for 5 additional years. The trial results suggest that a shorter...
Actively Recruiting Clinical Trials Focused on Cancer Prevention
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on preventing cancer. These studies are investigating a multitude of methods, including educational interventions; imaging devices; dietary changes/supplements; weight management;...
First Interim Analysis of Phase III SEQUOIA Trial in Pancreatic Cancer
ARMO BioSciences, Inc, recently announced the completion of the first interim analysis in its phase III SEQUOIA trial in patients with pancreatic cancer. The Data Monitoring Committee (DMC) for SEQUOIA, a clinical trial studying pegilodecakin (AM0010) plus FOLFOX (leucovorin,...
FDA Expands Approval of Blinatumomab for Certain Patients With B-Cell Precursor ALL
The U.S. Food and Drug Administration granted accelerated approval to blinatumomab (Blincyto) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). In patients who have achieved remission after...
Analyses of Radiographic Progression-Free Survival in Metastatic Castration-Resistant Prostate Cancer
As reported in JAMA Oncology by Rathkopf et al, sensitivity analyses of radiographic progression-free survival in the PREVAIL trial comparing enzalutamide vs placebo in metastatic castration-resistant prostate cancer support use of the measure as a clinically meaningful endpoint in trials in this...
When Is Active Surveillance Appropriate in the Treatment of DCIS?
In 2017, more than 63,000 women in the United States were diagnosed with in situ breast cancer. The overwhelming majority of those women, about 83%, were diagnosed with ductal carcinoma in situ (DCIS), a condition characterized by the presence of abnormal cells confined to the breast milk ducts;...
FDA Expands Approval of Brentuximab Vedotin for First-Line Treatment of Stage III or IV Classical Hodgkin Lymphoma in Combination With Chemotherapy
On March 20, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (Adcetris) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy. “Today’s approval represents an improvement in the initial...
Conquer Cancer Foundation Recognizes 70 Young Oncology Researchers’ Findings With Merit Awards
ASCO’s Conquer Cancer Foundation is pleased to announce the recipients of its Merit Awards in gastrointestinal cancers, clinical immuno-oncology, genitourinary cancers, and cancer survivorship. The following 70 researchers— oncology fellows and trainees honored for the quality and scientific merit...
New NCCN Guidelines Aim to Encourage More People Living With HIV and Cancer to Receive Appropriate Cancer Treatment
The National Comprehensive Cancer Network® (NCCN) has released new NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) intended to help make sure people living with human immunodeficiency virus (HIV) who are diagnosed with cancer receive safe, necessary treatment. According to a...
