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Showing 6351 - 6400Recent FDA Actions Include New Formulation, Expanded Indications for Oncology-Hematology Drug Products
The U.S. Food and Drug Administration (FDA) recently granted approval to olaparib tablets (Lynparza) as a maintenance therapy for ovarian cancer and to inotuzumab ozogamicin (Besponsa), for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)....
Multiple Myeloma: Researchers Are Digging Deeper Than Ever
Researchers are tackling multiple myeloma from many angles, and the result could be a flood of novel approaches soon within the oncologist’s reach, according to Kenneth C. Anderson, MD. At the 2017 Debates and Didactics in Hematology and Oncology Conference at Sea Island, Georgia, Dr. Anderson...
Targeted Treatments and Health-Related Quality of Life in Ovarian Cancer
Novel targeted treatment strategies and new trial endpoints in recurrent, platinum-sensitive ovarian cancer were highlighted in a gynecologic cancer session at the Best of ASCO New Orleans. At the meeting, Karen McLean, MD, PhD, of the University of Michigan Medical Center, Ann Arbor, presented...
Overall Survival With Carfilzomib vs Bortezomib in Relapsed or Refractory Multiple Myeloma
As reported by Dimopoulos et al in The Lancet Oncology, a prespecified interim analysis of the phase III ENDEAVOR trial has shown a significant overall survival benefit for carfilzomib (Kyprolis) vs bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma. Carfilzomib was...
Adding Adjuvant Erlotinib to Gemcitabine After R0 Resection of Pancreatic Cancer
The German phase III CONKO-005 trial has shown no significant benefit of adding adjuvant erlotinib (Tarceva) to gemcitabine after R0 resection in patients with pancreatic ductal adenocarcinoma. The findings were reported in the Journal of Clinical Oncology by Sinn et al. Study Details In the...
Pembrolizumab vs Ipilimumab in Advanced Melanoma: Final Overall Survival Analysis of KEYNOTE-006
The final overall survival analysis of the phase III KEYNOTE-006 trial showed maintained superiority of pembrolizumab (Keytruda) vs ipilimumab (Yervoy) in advanced melanoma. The results were reported by Schachter et al in The Lancet. An interim analysis showed improved progression-free and overall...
Tivozanib Approved in the European Union for the Treatment of Advanced Renal Cell Carcinoma
On August 28, AVEO Oncology announced that the European Commission (EC) has approved tivozanib (Fotivda) for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland. Tivozanib is indicated for the first-line treatment of adult patients with...
Phase III ALCYONE Study of Daratumumab in Front-Line Treatment of Multiple Myeloma
On August 24, positive topline results were announced from the phase III ALCYONE study of daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) vs VMP alone as front-line treatment for newly diagnosed patients who are not considered candidates for...
Association of Systemic Inflammation and Sarcopenia With Survival in Early-Stage Colorectal Cancer
Results from the C SCANS (Colorectal Cancer: Sarcopenia, Cancer, and Near-Term Survival) study indicate that prediagnosis systemic inflammation and at-diagnosis sarcopenia are associated with an increased mortality risk in patients with nonmetastatic colorectal cancer. The findings were reported in ...
FDA Accepts sBLA, Grants Priority Review for Obinutuzumab in Previously Untreated Follicular Lymphoma
On August 28, the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for obinutuzumab (Gazyva) in combination with chemotherapy followed by obinutuzumab alone for patients with previously untreated follicular lymphoma....
FDA Approves Fulvestrant as Monotherapy for Expanded Use in Breast Cancer
On August 28, the U.S. Food and Drug Administration (FDA) approved fulvestrant (Faslodex) at 500 mg as monotherapy for expanded use in women with hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer who have gone through menopause...
Obinutuzumab vs Rituximab Plus CHOP in Previously Untreated Diffuse Large B-Cell Lymphoma
The phase III GOYA trial has shown no progression-free survival advantage with obinutuzumab (Gazyva) vs rituximab (Rituxan) plus CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in previously untreated patients with advanced diffuse large B-cell lymphoma (DLBCL). The results were...
Reduced-Dose Cabazitaxel After Docetaxel in Metastatic Castration-Resistant Prostate Cancer
In the phase III PROSELICA trial reported by Eisenberger et al in the Journal of Clinical Oncology, a cabazitaxel (Jevtana) dose of 20 mg/m2 (C20) was noninferior for overall survival vs the currently recommended dose of 25 mg/m2 (C25) after docetaxel treatment in metastatic castration-resistant...
African American Men Have Lowest Survival Rates Among Patients With Anal Cancer
Over the past 30 years, squamous cell carcinoma of the anus has been one of the few cancers with a steadily rising incidence in the United States, with the most rapid increase seen in black men. To further investigate this trend, researchers at the University of Texas Southwestern Medical Center...
Prolonged and Intensified Neoadjuvant Therapy for Esophageal Adenocarcinoma
A UK phase III trial (UK MRC OE05) has shown no significant survival benefit of extended and intensified neoadjuvant chemotherapy with epirubicin, cisplatin, and capecitabine vs standard cisplatin/fluorouracil followed by resection in patients with esophageal adenocarcinoma. The findings were...
Anti–Trop-2 Antibody-Drug Conjugate Produces Durable Responses in Metastatic Triple-Negative Breast Cancer
AS REPORTED in the Journal of Clinical Oncology by Aditya Bardia, MD, MPH, of Massachusetts General Hospital Cancer Center and Harvard Medical School, and colleagues, the anti–Trop-2 antibody-drug conjugate sacituzumab govitecan has been found to produce durable responses in patients with heavily...
Adjuvant Temozolomide in 1p/19q Non-Codeleted Anaplastic Glioma
Interim results of the phase III CATNON trial (EORTC study 26053-22054) indicate a survival benefit of adjuvant temozolomide in 1p/19q non-codeleted anaplastic glioma. These findings were reported in The Lancet by van den Bent et al. Study Details In the open-label 2 x 2 factorial trial, 745...
Osimertinib for EGFR-Positive NSCLC: The Phase III FLAURA Trial
RECENTLY ANNOUNCED DATA from the phase III FLAURA trial showed a statistically significant and clinically meaningful progression-free survival benefit with osimertinib (Tagrisso) compared to current first-line standard-of-care treatment (erlotinib [Tarceva] or gefitinib [Iressa]) in previously...
Detection of Early-Stage Cancers With Circulating Tumor DNA
In a bid to detect cancers early and in a noninvasive way, scientists at the Johns Hopkins Kimmel Cancer Center, Baltimore, reported they have developed a test that spots tiny amounts of cancer-specific DNA in blood, and have used it to accurately identify more than half of 138 people with...
Arsenic Trioxide and Reduced Anthracycline Dose in Pediatric Acute Promyelocytic Leukemia
In the phase III historically controlled Children’s Oncology Group (COG) AAML0631 trial, arsenic trioxide consolidation permitted the use of lower-dose anthracycline without appearing to compromise outcomes in pediatric patients with acute promyelocytic leukemia (APL). The results were...
Pursuing Combination Strategies With Checkpoint and Tyrosine Kinase Inhibitors in Hepatocellular Carcinoma
PRIMARY LIVER CANCER is the second leading cause of cancer-related death worldwide. Hepatocellular carcinoma accounts for 90% of liver cancer, with around 800,000 new cases diagnosed globally each year.1 In contrast to the stable or declining trends observed for most neoplasms, the incidence and...
International Consensus (or Not) on Management of Advanced Prostate Cancer
ALTHOUGH THE National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) strongly influence the management of advanced prostate cancer, they do not always reflect actual clinical practice. It turns out that in the real world, there are multiple areas ...
Cutting-Edge Induction Strategies and Novel Approach to Reducing Skeletal-Related Events Explored in Multiple Myeloma
THE ADDITION of daratumumab (Darzalex) to a triplet induction regimen led to good responses in newly diagnosed multiple myeloma, but not without toxicities. And in the treatment of myeloma bone disease, denosumab (Xgeva) in place of zoledronic acid preserved renal function and may be associated...
Updates of Key Trials in Metastatic Non–Small Cell Lung Cancer: KEYNOTE-024 and AvaALL
IMMUNOTHERAPY AND ANTIANGIOGENESIS were highlighted in a session on metastatic non–small cell lung cancer (NSCLC) at the Best of ASCO New Orleans meeting. Matthew Gubens, MD, MS, presented the selected abstracts from the ASCO Annual Meeting.1 Dr. Gubens is Associate Professor of Thoracic Medical...
‘Slow, Incremental Changes’ Are Increasing Participation of Older Adults in Clinical Trials
Older adults continue to be proportionally underrepresented in oncology clinical trials, but the participation rate of adults aged 65 and older is increasing by “slow, incremental changes,” Stuart M. Lichtman, MD, FACP, FASCO, noted in an interview with The ASCO Post. Prompting those changes are...
CheckMate-214: Nivolumab and Ipilimumab in Intermediate- and Poor-Risk Previously Untreated Advanced or Metastatic RCC
On August 15, Bristol-Myers Squibb Company announced topline results from the CheckMate-214 trial investigating nivolumab (Opdivo) in combination with ipilimumab (Yervoy) vs sunitinib (Sutent) in intermediate- and poor-risk patients with previously untreated advanced or metastatic renal cell...
FDA Accepts sBLA and Grants Priority Review for Brentuximab Vedotin in Cutaneous T-Cell Lymphoma
On August 16, the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for brentuximab vedotin (Adcetris) in patients with cutaneous T-cell lymphoma (CTCL). The sBLA and its acceptance is based on data from the phase III...
Recent FDA Actions Include New Drug Approvals in Leukemia, Expanded Approvals in Colorectal Cancer and Graft-vs-Host Disease
The U.S. Food and Drug Administration (FDA) recently granted approval, expanded approval, and breakthrough therapy designation to numerous treatments across a range of tumor types and malignancies. New Drug Approvals Daunorubicin-Cytarabine Combination (Vyxeos): On August 3, the FDA granted...
Unraveling the Complexities of Cellular Immunotherapy and Its Potential to Cure Some Cancers
This past fall, the Fred Hutchinson Cancer Research Center in Seattle opened an all-encompassing 9,222-square foot outpatient cellular immunotherapy clinic, specifically designed to serve patients participating in the center’s novel immunotherapy clinical trials, which mainly focus on chimeric...
Clinical Trials Actively Recruiting Patients With Stage II/III Colorectal Cancer
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on patients with stage II or III colorectal cancer. These studies highlight dietary intervention, supplements, immunotherapy, combination chemotherapy, neoadjuvant therapy, and...
Triple-Negative Breast Cancer: Practical Approach, Promising Research
Triple-negative breast cancer has a reputation for being a particularly challenging malignancy, but breast cancer specialist Nancy Davidson, MD, Senior Vice President of the Clinical Research Division at the Fred Hutchinson Cancer Research Center, Seattle, put this in perspective in a recent...
Effect of Azithromycin on Airflow Decline–Free Survival After Allogeneic HSCT for Hematologic Malignancy
The French phase III ALLOZITHRO trial, stopped early due to excessive hematologic relapse in the azithromycin group, showed worse airflow decline–free survival with azithromycin vs placebo after hematopoietic stem cell transplantation (HSCT) for hematologic malignancy. The study findings were ...
Partial-Breast and Reduced-Dose Radiotherapy After Breast-Conserving Surgery
The UK IMPORT LOW phase III trial has shown noninferiority in local relapse for partial-breast and reduced-dose vs standard whole-breast radiotherapy after breast-conserving surgery in early breast cancer. These study results were reported by Coles et al in The Lancet. Study Details In the...
First-Line Cabazitaxel vs Docetaxel in Metastatic Castration-Resistant Prostate Cancer
The phase III FIRSTANA trial has shown no difference in overall survival with two dose regimens of cabazitaxel (Jevtana) vs docetaxel in the first-line treatment of metastatic castration-resistant prostate cancer. Results were reported by Oudard et al in the Journal of Clinical Oncology....
Final Overall Survival Results of GOG 240 Trial Adding Bevacizumab to Chemotherapy in Advanced Cervical Cancer
As reported in The Lancet by Tewari et al, the final overall survival results of the phase III Gynecologic Oncology Group (GOG) 240 trial show continued benefit of the addition of bevacizumab (Avastin) to chemotherapy in patients with metastatic, persistent, or recurrent cervical carcinoma. Study...
Health-Related Quality of Life With Immediate vs Delayed ADT in Prostate Cancer
In a health-related quality-of-life study among patients in the phase III TOAD trial, immediate vs delayed androgen-deprivation therapy was associated with early worsening of androgen-deprivation therapy–related symptoms but few other comparative adverse effects on functioning or quality of...
Ovarian Function Recovery During Anastrozole Therapy in Postmenopausal Patients With Breast Cancer
In the phase III DATA trial reported in the Journal of the National Cancer Institute by van Hellemond et al, 12% of women with breast cancer who had chemotherapy-induced ovarian function failure experienced ovarian function recovery during 30 months of aromatase inhibitor therapy with anastrozole....
Blinatumomab in Advanced Acute Lymphoblastic Leukemia: A Brighter Therapeutic Outlook
NEW DRUGS that will improve the outcome of adult patients who develop a deadly disease such as acute leukemia are badly needed; combinations of cytotoxic chemotherapeutic drugs may have reached an upper limit of utility. Agents that eradicate leukemia by alternative mechanisms would be of...
Improved Overall Survival With Blinatumomab vs Chemotherapy in Advanced Acute Lymphoblastic Leukemia
IN THE PHASE III TOWER TRIAL reported in The New England Journal of Medicine, Hagop Kantarjian, MD, of The University of Texas MD Anderson Cancer Center, and colleagues found that blinatumomab (Blincyto) treatment improved overall survival vs chemotherapy in heavily pretreated patients with B-cell ...
Alectinib: A New Standard for First-Line Therapy of ALK-Rearranged NSCLC?
ANAPLASTIC LYMPHOMA KINASE (ALK) was first identified in anaplastic large cell lymphoma. The ALK gene itself is not oncogenic, but it can become oncogenic by at least three mechanisms: by forming a fusion gene with a number of other partner genes, by copy number gain, or by mutations in the gene....
FDA Grants Alectinib Priority Review for Initial Treatment of ALK-Positive Lung Cancer
Today, the U.S. Food and Drug Administration (FDA) accepted Genentech’s supplemental New Drug Application (sNDA) and granted Priority Review for alectinib (Alecensa) as a first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive, locally advanced, or metastatic...
Sylvia
The following essay by Howard A. (Skip) Burris III, MD, is adapted from The Big Casino: America’s Best Cancer Doctors Share Their Most Powerful Stories, which was coedited by Stan Winokur, MD, and Vincent Coppola and published in May 2014. The book is available on Amazon.com and thebigcasino.org....
Osimertinib Improves Progression-Free Survival for EGFR-Positive NSCLC in the Phase III FLAURA Trial
On July 27, it was announced that the phase III FLAURA trial showed a statistically significant and clinically meaningful progression-free survival benefit with osimertinib (Tagrisso) compared to current first-line standard-of-care treatment (erlotinib [Tarceva] or gefitinib [Iressa]) in previously ...
Olaparib Tablets as Maintenance in BRCA1/2-Mutant Platinum-Sensitive Relapsed Ovarian Cancer
A phase III trial (SOLO2/ENGOT-Ov21) has shown improved progression-free survival with an olaparib tablet formulation vs placebo as maintenance therapy in patients with BRCA1/2-mutant platinum-sensitive relapsed ovarian cancer. These study results were reported by Pujade-Lauraine et al in The...
One Size May Not Fit All: Thoughts on the New Adjuvant Bisphosphonate Guideline for Early-Stage Breast Cancer
The oncology community has now conducted several prospectively designed, hypothesis-driven randomized clinical trials among women with breast cancer to address this question: Do adjuvant bisphosphonates decrease the risk of breast cancer bone metastases and other recurrence? A meta-analysis1 by...
Advances in the Treatment of Triple-Negative Breast Cancer
WITHIN THE SPECTRUM of breast cancer subtypes, triple-negative disease is “particularly troubling,” but better scientific understanding of this malignancy is leading to advances in its treatment, according to breast cancer expert Nancy Davidson, MD. Triple-negative breast cancer does not express...
Selected Abstracts on Novel Therapies for Hematologic Malignancies
THE 22ND CONGRESS of the European Hematology Association (EHA) was held in June in Madrid, drawing hematologists and allied professionals from every subspecialty of hematology from around the world. Among the extensive educational and scientific program, the EHA Congress provides a forum for...
New Data Reported on Vemurafenib, Vitamin D, Selective Internal Radiotherapy, and Circulating Tumor DNA in Colorectal Cancer
RESULTS OF the IDEA trial, which showed that some patients with stage III low-risk colon cancer may require less oxaliplatin therapy (see the June 25 issue of The ASCO Post), were among the findings highlighted at the 2017 ASCO Annual Meeting Plenary Session. Other studies of interest in colorectal ...
Expert Point of View: Frank Sinicrope, MD
FRANK SINICROPE, MD, Professor of Oncology and Co-Leader of the GI Cancer Program at the Mayo Clinic, Rochester, said CHARTA addressed whether patient outcomes can be improved with a triplet regimen plus bevacizumab (Avastin) vs a standard doublet plus bevacizumab. This was based upon the finding...
FDA Actions Yield Extended Approvals of Novel Agents, Advisory Committee Votes Favorably on Two Biosimilars and Pediatric Indication for CAR T-Cell Therapy
DURING JULY, the U.S. Food and Drug Administration (FDA) and its Oncologic Drugs Advisory Committee (ODAC) made a number of approvals and recommendations on a variety of oncology products. Neratinib ON JULY 1 7, the FDA approved neratinib (Nerlynx) for the extended adjuvant treatment of adult...
