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Showing 3151 - 3200FDA 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...
Sacituzumab Govitecan in Heavily Pretreated Metastatic Triple-Negative Breast Cancer: A Step in the Right Direction
IN A SINGLE-ARM multicenter trial reported by Bardia and colleagues1 and reviewed in this issue of The ASCO Post, the use of sacituzumab govitecan (IMMU-132) showed a response rate of 30% and a clinical benefit rate of 46% in heavily pretreated patients with metastatic triple-negative breast...
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...
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...
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...
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...
FDA Expands Ibrutinib Indications to Chronic Graft-vs-Host Disease
On August 2, 2017, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica) for the treatment of adult patients with chronic graft-vs-host disease after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of chronic...
In Case You Missed It: Short Takes on Current Cancer Research
MOST ONCOLOGISTS are familiar with the findings of the plenary sessions featured at the 2017 ASCO Annual Meeting, with topics ranging from the duration of adjuvant oxaliplatin-based therapy in stage III colon cancer to patient-reported outcomes for symptom monitoring during routine cancer...
FDA’s First Site-Agnostic Drug Approval Marks a Paradigm Shift in Regulatory Criteria
IN MAY, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with solid tumors that have the microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) biomarker, which disrupts the ability of cells to repair DNA. The...
FDA Approves Enasidenib in Relapsed or Refractory Acute Myeloid Leukemia
Today, the U.S. Food and Drug Administration (FDA) approved enasidenib (Idhifa) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which ...
FDA Approves Nivolumab in MSI-H or dMMR Metastatic Colorectal Cancer
Today, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) injection for intravenous use for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer...
FDA Grants Durvalumab Breakthrough Therapy Designation for Patients With Locally Advanced Unresectable NSCLC
On July 31, AstraZeneca and MedImmune (AstraZeneca’s global biologics research and development arm) announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for durvalumab (Imfinzi) for the treatment of patients with locally advanced,...
NCI-COG Pediatric MATCH Trial to Test Targeted Drugs in Childhood Cancers
Today, investigators at the National Cancer Institute (NCI) and the Children’s Oncology Group (COG) announced the opening of enrollment for a unique precision medicine clinical trial. NCI-COG Pediatric Molecular Analysis for Therapy Choice (Pediatric MATCH) is a nationwide trial to explore...
FDA Expands Approval of Ipilimumab to Include Pediatric Patients 12 Years and Older With Unresectable or Metastatic Melanoma
Today, the U.S. Food and Drug Administration (FDA) expanded the indication for ipilimumab (Yervoy) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Ipilimumab was evaluated in 2 trials of pediatric...
Pembrolizumab and Cetuximab-Treated Head and Neck Cancer: Activity Confirmed But No Surprises
WITH THE RECENT efficacy findings, improvements in survival, and resultant U.S. Food and Drug Administration (FDA) approvals of programmed cell death protein 1 (PD-1) immune checkpoint inhibitors across multiple solid tumor indications, the publication of yet another positive trial adds to the...
Pembrolizumab Is Active in Platinum- and Cetuximab-Refractory Head and Neck Cancer
IN THE PHASE II KEYNOTE-055 trial, pembrolizumab (Keytruda) was found to produce durable responses in patients with platinum- and cetuximab (Erbitux)-refractory head and neck squamous cell carcinoma.1 Results of the trial were reported by Joshua Bauml, MD, of the University of Pennsylvania,...
Pembrolizumab in Second-Line Therapy for Advanced Urothelial Carcinoma
THE TREATMENT OF metastatic urothelial carcinoma experienced a long period of stagnation until the recognition that targeting the programmed cell death protein 1 (PD-1) pathway could yield deep and durable responses.1-3 Cisplatin-based combination chemotherapy has been the reference standard for...
Ongoing Research in Cancer Immunotherapy for Children With Leukemia
THE CANCER IMMUNOTHERAPY PROGRAM at Children’s Hospital of Philadelphia has several clinical trials of chimeric antigen receptor (CAR) T-cell therapy available to eligible patients. Pilot Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRζ and 4-1BB Signaling...
Breast Cancer and Brain Metastases: Whole-Brain Radiotherapy May Not Be the Answer
FOR PATIENTS WITH BREAST CANCER who have metastases to the central nervous system (CNS), clinicians should think twice before administering whole-brain radiotherapy, according to Kimberly Blackwell, MD, Professor of Medicine and Assistant Professor of Radiation Oncology at Duke University Medical...
Combination Strategies for Jump-Starting the Immune Response
CHECKPOINT INHIBITORS have dramatically changed the landscape of the treatment of melanoma, lung, bladder, and other cancers. Researchers are focusing on exploring ways to extend the use of checkpoint inhibitors to other disease states and to combine them with novel agents and improve outcomes. At ...
Pivotal CAR T-Cell Data Reported in Relapsed/Refractory B-Cell ALL
UPDATED RESULTS from the ELIANA clinical trial of CTL019 (tisagenlecleucel)—an investigational chimeric antigen receptor (CAR) T-cell therapy—found that remission rates are maintained at 6 months in relapsed/refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia....
Drug Combinations Prove Effective Against Melanoma Brain Metastases
STUDIES PRESENTED at the 2017 ASCO Annual Meeting have shown that for melanoma that metastasizes to the brain, the combined use of checkpoint inhibitors and targeted agents can be effective. In COMBI-MB, 58% of patients responded intracranially to the BRAF inhibitor dabrafenib (Tafinlar) plus the...
Nivolumab Plus Ipilimumab in Metastatic Renal Cell Carcinoma
The phase I CheckMate 016 trial has shown activity of the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) in metastatic renal cell carcinoma. These findings were reported in the Journal of Clinical Oncology by Hammers et al. Study Details In the dose-escalation study, patients were...
Blinatumomab Granted Full Approval to Treat Relapsed or Refractory B-cell Precursor ALL in Adults and Children
On July 11, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for blinatumomab (Blincyto) to include overall survival data from the phase III TOWER study. The approval converts blinatumomab's accelerated approval to a full approval. The sBLA...
Idarubicin vs High-Dose Daunorubicin Induction in Newly Diagnosed Acute Myeloid Leukemia
A Korean phase III trial has shown no difference in outcomes with high-dose daunorubicin vs idarubicin induction in newly diagnosed acute myeloid leukemia, although high-dose daunorubicin was associated with better outcomes in patients with FLT3–internal tandem duplication (ITD) mutation....
FDA Approves Aminolevulinic Acid Hydrochloride as an Optical Imaging Agent Indicated in Gliomas
ON JUNE 6, the U.S. Food and Drug Administration (FDA) approved aminolevulinic acid hydrochloride, known as ALA HCl (Gleolan), as an optical imaging agent indicated in patients with gliomas (suspected World Health Organization [WHO] grades III or IV) for preoperative imaging, as an adjunct for the...
Has a New Standard Really Been Established for the Adjuvant Treatment of Pancreatic Cancer?
THE PAST YEAR has undoubtedly been a disappointing one as far as clinical advances in pancreatic cancer go. No fewer than five high-profile randomized phase II or III trials in this setting reported negative results in 2016, ranging from next-generation cytotoxic agents1 to novel immunotherapeutic ...
Autologous and Allogeneic Hematopoietic Cell Transplantation
HERE ARE SEVERAL ABSTRACTS selected from the proceedings of the 2016 American Society of Hematology (ASH) Annual Meeting & Exposition, highlighting clinical trials on autologous and allogeneic hematopoietic cell transplantation for various hematologic malignancies. Additional selected...
Dacomitinib Outperforms Gefitinib in EGFR-Positive NSCLC
DACOMITINIB, a second-generation epidermal growth factor receptor (EGFR)-targeted tyrosine kinase inhibitor, outperformed gefitinib (Iressa) as first-line treatment for EGFR-positive advanced non–small cell lung cancer (NSCLC) in the phase III ARCHER 1050 study.1 Dacomitinib improved...
Final Results of European Trial in Mucosa-Associated Lymphoid Tissue Lymphoma
The final results of the European phase III International Extranodal Lymphoma Study Group (IELSG)-19 trial, reported in the Journal of Clinical Oncology by Emanuele Zucca, MD, of the IELSG Operation Office, Oncology Institute of Southern Switzerland, and colleagues showed that event-free and...
Atezolizumab/Bevacizumab Moves Forward in Metastatic Renal Cell Carcinoma
THE COMBINATION of atezolizumab (Tecentriq) plus bevacizumab (Avastin) showed promising results as first-line treatment of patients with metastatic renal cell carcinoma, according to a phase II trial called IMmotion 150. Based on these results, the phase III IMmotion 151 trial is comparing...
Ublituximab/Ibrutinib Beneficial in Patients With Chronic Lymphocytic Leukemia
The addition of ublituximab (a glycoengineered anti-CD20 antibody) to ibrutinib (Imbruvica) improved response rates, depth of response, and led to quicker resolution of ibrutinib-associated lymphocytosis in patients with high-risk chronic lymphocytic leukemia (CLL) in the phase III GENUINE trial,...
Pembrolizumab Moving Forward in Triple-Negative Breast Cancer
In the treatment of triple-negative breast cancer, checkpoint inhibition is making inroads in both early- and late-stage disease, and the line of treatment and expression of the programmed cell death ligand 1 (PD-L1) could be important in determining outcomes, according to studies reported at the...
FDA Approves Daratumumab in Combination With Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has approved the use of the monoclonal antibody daratumumab -(Darzalex) in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide ...
Phase III CASCADE Trial of Vadastuximab Talirine in Front-Line AML Discontinued
On June 22, 2017, Seattle Genetics confirmed it discontinued the phase III CASCADE clinical trial of vadastuximab talirine (SGN-CD33A) in front-line older acute myeloid leukemia (AML) patients. Patient enrollment and treatment in all of its vadastuximab talirine clinical trials are suspended,...
European Commission Expands Use of Ceritinib for First-Line Use in ALK-Positive Advanced NSCLC
On June 29, the European Commission approved expanding the use of ceritinib (Zykadia) to include the first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)–positive. Approval follows a positive opinion granted...
First-Line Cetuximab vs Bevacizumab Plus Chemotherapy in KRAS Wild-Type Advanced Colorectal Cancer
A phase III trial has shown no significant difference in overall survival with first-line cetuximab (Erbitux) vs bevacizumab (Avastin) plus chemotherapy in patients with advanced or metastatic KRAS wild-type colorectal cancer. These study findings were reported by Venook et al in JAMA. The trial...
EHA 2017: Updated CTL019 ELIANA Data Show Durable Remission Rates in Children, Young Adults With Relapsed/Refractory B-Cell ALL
Updated results from the ELIANA clinical trial demonstrated CTL019 (tisagenlecleucel) remission rates are maintained at 6 months in relapsed/refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). These data from this pivotal trial of CTL019 show that 83% (52...
FDA Approves Betrixaban for the Prophylaxis of Venous Thromboembolism
On June 23, 2017, the U.S. Food and Drug Administration (FDA) approved betrixaban (Bevyxxa) for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility...
FDA Approves Daratumumab in Combination With Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has approved the use of the monoclonal antibody daratumumab (Darzalex) in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide...
Phase III CASCADE Trial of Front-Line Vadastuximab Talirine in AML Discontinued
Seattle Genetics has discontinued its phase III CASCADE clinical trial of front-line vadastuximab talirine (SGN-CD33A) in older acute myeloid leukemia (AML) patients. The phase III CASCADE clinical trial is a randomized, double-blind, placebo-controlled study evaluating vadastuximab talirine...
