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Showing 151 - 200Rucaparib in Previously Treated BRCA Mutation–Associated Ovarian Cancer
On December 19, 2016, rucaparib (Rubraca) was granted accelerated approval for the treatment of patients with deleterious BRCA mutation–associated (germline or somatic) advanced ovarian cancer who have received two or more prior chemotherapy regimens.1,2 The U.S. Food and Drug Administration (FDA) ...
2017 GI Cancers Symposium: Nivolumab Demonstrated Efficacy and Improved Survival in Patients With Previously Treated Advanced Gastric Cancer
Results of the ONO-4538-12 trial demonstrated that nivolumab (Opdivo) significantly reduced the risk of death by 37% (hazard ratio [HR] = 0.63; P < .0001) in patients with previously treated advanced gastric cancer refractory to or intolerant of standard therapy, a condition without current ...
Nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
On November 10, 2016, nivolumab (Opdivo) was approved for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.1,2 Supporting Efficacy Data Approval was based on the finding of an overall survival advantage...
Pembrolizumab in First-Line Treatment of Metastatic Non–Small Cell Lung Cancer
On October 24, 2016, pembrolizumab (Keytruda) was approved for use in patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have high programmed cell death ligand 1 (PD-L1) expression (tumor proportion score ≥ 50%) as determined by a U.S. Food and Drug Administration...
SITC 2016: Phase I/II Data Combining Urelumab With Nivolumab Suggest Increased Antitumor Effect in Patients With Melanoma
Safety and efficacy data from a phase I/II study of urelumab in combination with nivolumab (Opdivo) in patients with hematologic and solid tumors, including biomarker analyses by level of programmed death ligand 1 (PD-L1) expression, was recently presented at the Society for Immunotherapy of Cancer ...
Atezolizumab in Previously Treated Metastatic NSCLC
On October 18, 2016, the anti–PD-L1 (programmed cell death ligand 1) antibody atezolizumab (Tecentriq) was approved for the treatment of metastatic non–small cell lung cancer (NSCLC) progressing during or following platinum-containing chemotherapy.1,2 Patients with epidermal growth factor receptor ...
Use of Pembrolizumab in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma After Platinum-Containing Therapy
On August 5, 2016, pembrolizumab (Keytruda) was granted accelerated approval for treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma and disease progression on or after platinum-containing chemotherapy.1,2 As a condition of the accelerated approval, Merck is...
FDA Accepts New Drug Application, Grants Priority Review of Rucaparib for the Treatment of Advanced BRCA-Mutant Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has accepted Clovis Oncology’s New Drug Application (NDA) for accelerated approval of rucaparib and granted Priority Review status to the application with a Prescription Drug User Fee Act date of February 23, 2017. Rucaparib is an...
Cancer Research Institute to Honor Three Scientists for Outstanding Contributions to Cancer Immunotherapy Research
The Cancer Research Institute (CRI), a nonprofit organization established in 1953 to advance biomedical research with the goal of developing lifesaving immunotherapies for all forms of cancer, will bestow its highest honors on three scientists who have made fundamental contributions to the fields...
Nivolumab in Classical Hodgkin Lymphoma
On May 17, 2016, nivolumab (Opdivo) was granted accelerated approval for treatment of patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin (Adcetris).1,2 Continued approval for ...
PD-L1 Inhibitor Atezolizumab for Locally Advanced or Metastatic Urothelial Carcinoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.On May 18, 2016, the PD-L1 (programmed cell death ligand 1)...
AACR Welcomes New Board of Directors, Nominating Committee Members
The members of the American Association for Cancer Research (AACR) have elected five members to serve on the AACR Board of Directors for the 2016–2019 term and four members to serve on the Nominating Committee for the 2016–2018 term. They began their terms at the 2016 AACR Annual Meeting, held...
Crizotinib in ROS1-Positive Metastatic Non–Small Cell Lung Cancer
On March 11, 2016, crizotinib (Xalkori) was approved for treatment of patients with metastatic non–small cell lung cancer (NSCLC) with ROS1 rearrangement–positive tumors.1,2 A U.S. Food and Drug Administration–approved test for the detection of ROS1 rearrangements in NSCLC is not currently...
Mary-Claire King, PhD, Awarded 2016 Szent-Györgyi Prize for Progress in Cancer Research
The National Foundation for Cancer Research has announced that Mary-Claire King, PhD, Professor of Genome Sciences and Medicine (Medical Genetics) at the University of Washington, Seattle, has been awarded the 2016 Szent-Györgyi Prize for Progress in Cancer Research. The National Foundation for...
Nivolumab Plus Ipilimumab in Unresectable or Metastatic Melanoma Regardless of BRAF Mutation Status
On January 23, 2016, the indication for nivolumab (Opdivo) plus ipilimumab (Yervoy) in unresectable or metastatic melanoma was expanded through accelerated approval to include patients regardless of BRAF V600 mutation status.1 The combination was previously approved for treatment of patients with...
Alectinib in ALK-Positive Metastatic NSCLC After Crizotinib
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 11, 2015, alectinib (Alecensa) was granted...
Expanded Approval of Pembrolizumab in Unresectable or Metastatic Melanoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On December 18, 2015, approval of the programmed cell death...
Severe Toxicities Seen in Younger Patients Receiving Front-Line Idelalisib for Chronic Lymphocytic Leukemia
Hematologists and patients with chronic lymphocytic leukemia (CLL) are excited about new drugs that have dramatically improved outcomes. But all drugs have side effects, and it is important to be aware of potential consequences. Hepatotoxicity turns out to be a major concern in younger CLL patients ...
Idelalisib Improves Progression-Free Survival Over Bendamustine Plus Rituximab in Chronic Lymphocytic Leukemia
Idelalisib (Zydelig) combined with bendamustine (Bendeka, Treanda) plus rituximab (Rituxan) was superior to chemotherapy with bendamustine/rituximab plus placebo, reducing the risk of progressive disease and death while improving progression-free survival and overall survival in patients with...
Study Finds Alectinib Highly Active in ALK-Positive, Crizotinib-Resistant NSCLC
In a North American phase II trial reported in The Lancet Oncology, Shaw et al found that alectinib (Alecensa), which is active against acquired crizotinib (Xalkori) resistance mutations and exhibits high central nervous system (CNS) penetration, was associated with considerable activity in...
Nivolumab Plus Ipilimumab Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status
Bristol-Myers Squibb announced on January 23 that the U.S. Food and Drug Administration (FDA) has approved nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation–positive unresectable or metastatic...
Understanding Crizotinib, 1 Year after High-profile Presentation
The findings from a phase I study of crizotinib in non–small cell lung cancer (NSCLC) were presented in a Plenary Session at the 2010 ASCO Annual Meeting—an unusual event, since such early-phase data are not generally the topic of plenary sessions. The study showed that a majority of mostly...
Novel Drugs Ipilimumab and Vemurafenib for Advanced Melanoma
In this introductory installment of In the Clinic, The ASCO Post provides an overview of two new melanoma agents recently approved by FDA, with discussion on pivotal data leading to approval, dosage and administration, and managing drug-related toxicities. Watch for more on clinical use of novel...
Crizotinib: New Drug for ALK-positive Advanced Non–Small Cell Lung Cancer
Indication Crizotinib (Xalkori) is an oral inhibitor of receptor tyrosine kinases including anaplastic lymphoma kinase (ALK), hepatocyte growth factor receptor (HGFR, c-Met), and recepteur d’origine nantais (RON). In August 2011, the FDA granted the drug accelerated approval for the treatment of...
Abiraterone: New Drug in the Treatment of Metastatic Castration-resistant Prostate Cancer
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication Abiraterone acetate (Zytiga) (an oral agent that...
What You Should Know about Peginterferon Alfa-2b for Adjuvant Treatment of Melanoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication Peginterferon alfa-2b (PegIntron, Sylatron) was recently ...
Vandetanib: New Drug for Unresectable Medullary Thyroid Cancer
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication The oral kinase inhibitor vandetanib (Caprelsa) was...
Pazopanib: New Drug for Advanced Soft-tissue Sarcoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In April 2012, pazopanib (Votrient) was approved for the ...
Ziv-aflibercept with FOLFIRI in Metastatic Colorectal Cancer
In August 2012, the antiangiogenic agent ziv-aflibercept (Zaltrap) was approved for use in combination with FOLFIRI (fluorouracil, leucovorin, irinotecan) for the treatment of metastatic colorectal cancer resistant to or progressing after an oxaliplatin-containing regimen.1,2 Approval was based on...
Enzalutamide for Metastatic Castrate-resistant Prostate Cancer
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In August 31, enzalutamide (Xtandi) was approved for the ...
Bosutinib in Chronic Myelogenous Leukemia Patients with Resistance or Intolerance of Prior Therapy
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In September 4, 2012, bosutinib (Bosulif) was approved...
Kinase Inhibitors Compared in First-line Treatment of CML
Bosutinib (Bosulif) is an oral dual Src/Abl kinase inhibitor that is active against many Bcr-Abl mutations associated with imatinib (Gleevec) resistance and that has reduced activity against nonspecific molecular targets associated with toxicities reported for other second-generation kinase...
Phase II Study Suggests Advantage of Irreversible Pan-HER Inhibition in Advanced NSCLC
Dacomitinib is a new tyrosine kinase inhibitor that forms irreversible covalent bonds with the ATP domain of each of the three kinase-active members of the HER family—EGFR/HER1, HER2, and HER4. Agents such as erlotinib (Tarceva) and gefitinib (Iressa), which are of proven benefit in advanced...
Regorafenib, Multikinase Inhibitor, for Previously Treated Metastatic Colorectal Cancer
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On September 27, 2012, regorafenib (Stivarga) was...
FDA Expands Abiraterone’s Use for Late-stage Prostate Cancer
In December, the FDA approved an expanded indication for abiraterone acetate (Zytiga) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer. Trial Design The approval was based on a trial randomly assigning patients with metastatic...
Omacetaxine for Chronic or Accelerated Phase CML Patients with Resistance/Intolerance to Tyrosine Kinase Inhibitors
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On October 26, 2012, the FDA granted accelerated...
Cabozantinib in Metastatic Medullary Thyroid Cancer
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On November 29, 2012, cabozantinib (Cometriq) was...
Ponatinib in Chronic Myeloid Leukemia and Philadelphia Chromosome–positive Acute Lymphoblastic Leukemia
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On December 14, 2012, ponatinib (Iclusig) was granted...
Abiraterone in Patients with Metastatic Castration-resistant Prostate Cancer and No Prior Chemotherapy
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On December 10, 2012, abiraterone acetate (Zytiga)...
Abiraterone Benefits Patients with Metastatic Prostate Cancer Who Have Had No Previous Chemotherapy
The androgen biosynthesis inhibitor abiraterone acetate (Zytiga) has been shown to increase radiographic progression-free survival and delay clinical decline and initiation of chemotherapy in a clinical trial in castration-resistant patients with metastatic prostate cancer who have had no prior...
Oral S-1 Noninferior to Gemcitabine in Advanced Pancreatic Cancer in Japan and Taiwan
As reported by Hideki Ueno, MD, PhD, of National Cancer Center Hospital, Tokyo, and colleagues in Journal of Clinical Oncology, treatment with the oral fluoropyrimidine derivative S-1 was associated with noninferior overall survival and reduced hematologic toxicity compared with gemcitabine...
Trametinib in Unresectable or Metastatic Melanoma with BRAF V600E or BRAF V600K Mutation
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On May 29, 2013, trametinib (Mekinist) was approved by...
Second-generation ALK Inhibitor Breakthrough Drug Promising in Early Study for Non–Small Cell Lung Cancer
Encouraging results were seen in a preliminary study of a second-generation ALK inhibitor in advanced ALK-positive non–small cell lung cancer (NSCLC). The drug—dubbed LDK378—achieved tumor shrinkage in almost all patients enrolled in the study, in all mutational subsets, in crizotinib...
Addition of Brivanib to Cetuximab in Chemotherapy-refractory Metastatic Wild-type KRAS Colorectal Cancer: Key Results
The addition of a combination of epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) inhibitors to chemotherapy has not improved outcome in first-line treatment of advanced colorectal cancer. However, in early-phase evaluation, the addition of the investigational...
Lenalidomide in Relapsed/Progressed Mantle Cell Lymphoma after Two Prior Therapies Including Bortezomib
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On June 5, 2013, lenalidomide (Revlimid) was approved...
Dr. Joseph Bertino's Breakthrough Work in Methotrexate Resistance Led to Understanding Why Cancer Drugs Work or Fail
Looking over his 5 decades in clinical oncology and research, Joseph R. Bertino, MD, says his greatest professional satisfaction comes from seeing his former students and oncology fellows go on to achieve great success in their own medical and research careers. It is a fitting sentiment since Dr....
Progression-Free Survival With Pazopanib Not Inferior to Sunitinib Benefit in Metastatic Renal Cell Carcinoma
Pazopanib (Votrient) and sunitinib (Sutent) have been shown to provide progression-free survival benefit compared with placebo or interferon in phase III trials in metastatic renal cell carcinoma. In a noninferiority trial reported in The New England Journal of Medicine by Robert J. Motzer, MD, of...
Applying Molecular Profiling to Clinical Practice: Promises and Challenges
A “new kind of pathology,” with anatomy and histology being supplemented by molecular etiology, has been emerging over the past decade and promises better response rates among patients with cancer, as genomic alterations continue to be identified and treated with targeted therapies. “The list of...
Cabozantinib Improves Disease-Free Survival in Progressive Medullary Thyroid Cancer
Cabozantinib (Cometriq) is an inhibitor of hepatocyte growth factor receptor (MET), vascular endothelial growth factor receptor 2 (VEGFR2), and rearranged during transfection (RET) tyrosine kinases. In a phase III trial reported in Journal of Clinical Oncology, Rossella Elisei, MD, of University of ...
Brivanib Studied in First- and Second-Line Therapy for Advanced Hepatocellular Carcinoma
The investigational drug brivanib is a dual inhibitor of vascular endothelial growth factor and fibroblast growth factor signaling, both implicated in hepatocellular carcinoma. The agent was recently evaluated in two phase III trials, one comparing first-line brivanib with sorafenib (Nexavar) in...
