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hepatobiliary cancer

Internal Radiotherapy vs Kinase Inhibitor in Advanced Hepatocellular Carcinoma

A French phase III trial has shown no significant survival difference between selective internal radiotherapy with yttrium-90 resin microspheres vs sorafenib (Nexavar) in patients with advanced hepatocellular carcinoma. The findings were reported by Vilgrain et al in The Lancet Oncology. Study...

Gerold Bepler, MD, PhD, Elected to Association of American Cancer Institute’s Board of Directors

GEROLD BEPLER, MD, PhD, President and Chief Executive Officer of the Barbara Ann Karmanos Cancer Institute, has been elected to serve a 3-year term on the Association of American Cancer Institutes (AACI) Board of Directors. AACI comprises 97 leading cancer research centers in North America and is...

sarcoma
solid tumors

Conqueror in Action: Six-Time Survivor Brittany Sullivan Takes on Sarcoma

Alveolar soft part sarcoma (ASPS) is a cancer so rare that some oncologists have never heard of it. Brittany Sullivan, a 29-year-old anatomy teacher from Nashville, Tennessee, learned about it when she was 3 years old. She has been conquering it ever since. Since her childhood diagnosis, Ms....

colorectal cancer

AACR-NCI-EORTC: Colorectal Cancer Test Could Detect Early Cancer-Causing Genetic Biomarkers With High Degree of Sensitivity

An investigational test that screens for colorectal cancer could detect genetic mutations that are indicative of the disease with a high degree of sensitivity and specificity, according to results of a study presented by Powell et al at the AACR-NCI-EORTC International Conference on Molecular...

BE PREPARED TO ENCOURAGE HPV VACCINATION

“Human papillomavirus (HPV) vaccination coverage lags behind coverage for the other vaccines recommended for preteens,” according to the Centers for Disease Control and Prevention (CDC).1 A recent report about vaccination coverage in the United States among adolescents aged 13 to 17 found that...

FDA Awards Grants for Clinical Trials to Stimulate Product Development for Rare Diseases

THE U.S. FOOD and Drug Administration (FDA) has awarded numerous new clinical trial research grants, totaling more than $22 million over the next 4 years, to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and ...

multiple myeloma

Carfilzomib Improves Overall Survival vs Bortezomib in Relapsed/Refractory Multiple Myeloma

AT A PRESPECIFIED interim analysis, the phase III ENDEAVOR trial has shown a significant overall survival benefit for carfilzomib (Kyprolis) vs bortezomib (Velcade) in patients with relapsed/refractory multiple myeloma, as reported by Meletios A. Dimopoulos, MD, of the National and Kapodistrian...

issues in oncology

For HPV Vaccine to Have Optimal Impact, ‘Provider Hesitancy’ Must Be Overcome

Honoring National Cancer Institute researchers Douglas R. Lowy, MD, and John T. Schiller, PhD, with the Lasker-DeBakey Clinical Medical Research Award for advances in technology that enabled the development of human papillomavirus (HPV) vaccines to prevent cervical cancer and other tumors caused by ...

lymphoma

FDA Approves CAR T-Cell Therapy to Treat Adults With Certain Types of Large B-Cell Lymphoma

On October 18, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel (Yescarta), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment....

Stand Up To Cancer Catalyst Launches 10 Clinical Trial Projects

Stand Up To Cancer has awarded 10 Stand Up To Cancer Catalyst clinical trial projects in which researchers from more than 30 institutions collaborate across academic and corporate borders on clinical trials studying correlated translational research. The inaugural Stand Up To Cancer Catalyst...

FDA Clears 7T Magnetic Resonance Imaging Device

On October 12, the U.S. Food and Drug Administration (FDA) cleared the first 7-Tesla (7T) magnetic resonance imaging (MRI) device, more than doubling the static magnetic field strength available for use in the United States. The Magnetom Terra is the first 7T MRI system cleared for clinical use in...

hematologic malignancies

Potential Biomarkers to Identify Patients at Risk for Neurotoxicity From CAR T-Cell Therapy

Although lymphodepletion chemotherapy followed by an infusion of CD19-targeted chimeric antigen receptor (CAR)-modified T cells has produced high response rates in phase I studies of patients with refractory CD19-positive B-cell acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia...

lymphoma

Brentuximab Vedotin Granted FDA Breakthrough Therapy Designation in Front-Line Advanced Hodgkin Lymphoma

On October 2, Seattle Genetics, Inc, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to brentuximab vedotin (Adcetris) in combination with chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. The positive ...

palliative care

Integrative Therapies in Palliative Care Project

Palliative care professionals are invited to participate in a unique project sponsored by the National Cancer Institute. Collinge and Associates, Inc, is seeking interdisciplinary professionals to help develop and evaluate a new online continuing education (CE/CME) course on the use of integrative...

hepatobiliary cancer

FDA Accepts sNDA for Lenvatinib for the Treatment of Hepatocellular Carcinoma

On September 26, Eisai Inc announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for lenvatinib  (Lenvima) for potential use in the first-line treatment of patients with hepatocellular carcinoma. “Patients with...

solid tumors
bladder cancer

Avelumab in Locally Advanced or Metastatic Urothelial Carcinoma

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 May 9, 2017, avelumab (Bavencio) was granted...

hematologic malignancies
lymphoma
leukemia

Combination of Rituximab and Hyaluronidase Human for Subcutaneous Use in Lymphoma and Leukemia

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 22, 2017, the combination of rituximab (Rituxan)...

ACS Awards Grants to Reduce Colorectal Cancer Disparities in American Indian and Alaska Native Populations

The American Cancer Society (ACS) has awarded $100,000 in grants to five community health centers across the country to reduce colon cancer disparities in American Indian and Alaska Native populations through the Community Health Advocates implementing Nationwide Grants for Empowerment and Equity...

Fox Chase Cancer Center Announces New Faculty, Appointments

Under the direction of Martin J. Edelman, MD, Chair, Department of Hematology/Oncology, who joined Fox Chase Cancer Center earlier this year, the department has been reorganized into four sections: Hematologic Malignancies, Solid Tumor Oncology, General Hematology/Oncology, and Fox Chase at Temple...

lymphoma

Tisagenlecleucel for B-Cell Acute Lymphoblastic Leukemia

On August 30, 2017, tisagenlecleucel (Kymriah) was granted regular approval for the treatment of patients up to age 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.1,2 Tisagenlecleucel is the first chimeric antigen receptor (CAR)...

leukemia

Inotuzumab Ozogamicin for Relapsed/Refractory B-Cell Precursor ALL

On August 17, 2017, inotuzumab ozogamicin (Besponsa) was approved for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).1,2  Supporting Efficacy Data  APPROVAL WAS BASED on complete remission rates in the open-label phase III INO-VATE ALL...

gastrointestinal cancer

Regorafenib in Hepatocellular Carcinoma Previously Treated With Sorafenib

On April 27, 2017, the indications for regorafenib (Stivarga) were expanded to include treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data The new approval was based on the finding of improved overall survival...

gynecologic cancers

Final Efficacy Analysis of 9-Valent Human Papillomavirus Vaccine Trial

The final efficacy analysis of a trial of 9-valent human papillomavirus (HPV) vaccine has shown a high preventive effect against disease due to the additional HPV pathogenic strains covered compared with the quadrivalent vaccine at up to 6 years. These findings were reported by Huh et al in The...

lymphoma

FDA Approves Copanlisib for Adults With Relapsed Follicular Lymphoma

Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. “For patients with relapsed follicular lymphoma, the cancer often...

cns cancers
gynecologic cancers
kidney cancer
lung cancer
gastroesophageal cancer

FDA Approves First Biosimilar for the Treatment of Cancer

The U.S. Food and Drug Administration today approved bevacizumab-awwb (Mvasi) as a biosimilar to bevacizumab (Avastin) for the treatment of multiple types of cancer. Bevacizumab-awwb is the first biosimilar approved in the U.S. for the treatment of cancer. “Bringing new biosimilars to...

head and neck cancer

Pembrolizumab in PD-L1–Positive Nasopharyngeal Carcinoma

As reported by Hsu et al in the Journal of Clinical Oncology, pembrolizumab (Keytruda) has shown activity in programmed cell death ligand 1 (PD-L1)–positive recurrent or metastatic nasopharyngeal carcinoma, in a cohort of the phase Ib KEYNOTE-028 trial. Study Details In the study, 27...

colorectal cancer

First-Line Cetuximab vs Bevacizumab Plus Chemotherapy in KRAS Wild-Type 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 Alan Venook, MD, of University of ...

cns cancers

Addition of EGFR-Targeting Vaccine to Temozolomide in EGFRvIII-Expressing Glioblastoma

The phase III ACT IV study has shown no survival benefit of adding rindopepimut, a vaccine targeting the epidermal growth factor receptor (EGFR) deletion mutation EGFRvIII, to temozolomide in patients with newly diagnosed EGFRvIII-positive glioblastoma. These findings were reported by Weller et al...

solid tumors
bladder cancer

Atezolizumab in Patients With Advanced Urothelial Carcinoma Who Are Ineligible for Cisplatin

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 April 17, 2017, the programmed cell death ligand 1 (PD-L1)...

multiple myeloma

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...

leukemia

FDA Approves First CAR T-Cell Therapy for Pediatric and Young Adult Patients With B-Cell Precursor ALL

Today, the U.S. Food and Drug Administration (FDA) issued what it has called a “historic action,” making the first gene therapy available in the United States. The FDA approved tisagenlecleucel (Kymriah) for certain pediatric and young adult patients with a form of acute lymphoblastic...

multiple myeloma

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...

ASCO, CCF Congratulate 2017 Grant and Award Recipients

The Conquer Cancer Foundation of ASCO (CCF) presented more than $6.3 million in grants and awards to 247 promising oncology researchers at the 2017 ASCO Annual Meeting. CCF and ASCO congratulate the recipients on their contributions to the field of oncology and offer their profound thanks to the...

lymphoma

Crizotinib in Pediatric ALK-Positive Anaplastic Large Cell Lymphoma and Inflammatory Myofibroblastic Tumors

In a Children’s Oncology Group study, high response rates were achieved with crizotinib (Xalkori) treatment in pediatric ALK-positive anaplastic large cell lymphomas (ALCL) and inflammatory myofibroblastic tumors. These results were reported by Mossé et al in the Journal of Clinical...

prostate cancer

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 ...

skin cancer

Standard-Dose Pembrolizumab Plus Reduced-Dose Ipilimumab in Advanced Melanoma

In the phase IB KEYNOTE-029 study, standard-dose pembrolizumab (Keytruda) plus reduced-dose ipilimumab (Yervoy) produced high response rates in patients with advanced melanoma. These results were reported by Long et al in The Lancet Oncology. Study Details In the study, 153 patients with...

hepatobiliary cancer

FDA Approves Three-Drug Combination Tablet for Hepatitis C

On July 18, the U.S. Food and Drug Administration (FDA) approved a combination tablet (Vosevi) to treat adults with chronic hepatitis C virus genotypes 1–6 without cirrhosis or with mild cirrhosis. This fixed-dose, combination tablet contains two previously approved drugs—sofosbuvir and ...

lung cancer

FDA Approves First Companion Diagnostic Test to Simultaneously Screen for Multiple NSCLC Therapies

On June 22, the U.S. Food and Drug Administration (FDA) granted premarket approval to Thermo Fisher Scientific for the first next-generation sequencing–based test that simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non–small cell...

ASCO’s TAPUR Study Continues Its Expansion of Sites, Participants, and Collaborators

ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study continues to expand and now has more than 300 participants enrolled on study drugs, more than 100 sites in 20 states, new partnerships, and a -revised protocol to lower the age of eligibility. Recently, eight new centers in 36...

breast cancer

Expert Point of View: Leisha A. Emens, MD, PhD

STUDY DISCUSSANT Leisha A. Emens, MD, PhD, of Bloomberg~Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University, Baltimore, entitled her remarks, “Target Practice in Triple-Negative Breast Cancer,” referring to the fact that there is currently no validated target in this aggressive...

multiple myeloma

CAR T-Cell Therapy in Multiple Myeloma Yields 100% Response Rate

Chinese investigators reported that 100% of patients with relapsed or refractory multiple myeloma responded to autologous chimeric antigen receptor (CAR) T-cell therapy, and 14 of 19 (74%) who were followed for a median of 4 months achieved a stringent complete response and have not recurred.1...

breast cancer

Expert Point of View: Leisha A. Emens, MD, PhD

Leisha A. Emens, MD, PhD, of the Bloomberg~Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University, commented on the promise of anti–programmed cell death protein 1/programmed cell death ligand 1 (PD-1/PD-L1) agents in triple-negative breast cancer. She noted that “an emerging theme...

leukemia

Adding Idelalisib to Bendamustine/Rituximab in Relapsed/Refractory CLL

As reported by Andrew D. Zelenetz, MD, of Memorial Sloan Kettering Cancer Center, and colleagues in The Lancet Oncology, interim analysis of a phase III trial has shown the superiority of adding the phosphoinositide-3-kinase δ inhibitor idelalisib (Zydelig) to bendamustine/rituximab (Rituxan) in...

solid tumors

FDA Clears Expanded Use of Cooling Cap to Reduce Hair Loss During Chemotherapy

On July 3, the U.S. Food and Drug Administration (FDA) cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors. “We are pleased to expand the...

hematologic malignancies
leukemia
lymphoma
myelodysplastic syndromes

FDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and Lymphomas

On June 29, the U.S. Food and Drug Administration (FDA) allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency-authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin...

colorectal cancer

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...

lymphoma

Brentuximab Vedotin vs Physician’s Choice in CD30-Positive Cutaneous T-Cell Lymphoma

The phase III ALCANZA trial has shown that brentuximab vedotin (Adcetris) produces a higher global response rate vs physician’s choice of therapy in previously treated CD30-positive cutaneous T-cell lymphomas. These results were reported by Prince et al in The Lancet. Study Details In this...

breast cancer

Equivalence Trial of Neoadjuvant Trastuzumab Biosimilar CT-P6 vs Trastuzumab in HER2-Positive Breast Cancer

A phase III equivalence trial has shown comparable pathologic complete response rates with the proposed trastuzumab biosimilar CT-P6 vs reference trastuzumab (Herceptin) in neoadjuvant treatment of HER2-positive early breast cancer. The study was reported by Stebbing et al in The Lancet Oncology....

leukemia

ICML 2017: Phase III GENUINE Trial: Ublituximab Plus Ibrutinib in High-Risk CLL

Data was recently presented from the phase III GENUINE trial of ublituximab, a novel glycoengineered anti–CD20 monoclonal antibody, in combination with ibrutinib (Imbruvica), a Bruton tyrosine kinase (BTK) inhibitor, for the treatment of high-risk chronic lymphocytic leukemia (CLL), at the...

leukemia
lymphoma

ICML 2017: Triplet Combination of Umbralisib, Ublituximab, and Ibrutinib in CLL/SLL/NHL

Data from the chemotherapy-free triple combination of umbralisib, an oral, next generation PI3K delta inhibitor; ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody; and ibrutinib (Imbruvica) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and...

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