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FDA Grants Priority Review to Expanded Use of Gardasil 9 in Women and Men Aged 27 to 45 for the Prevention of Certain HPV-Related Cancers and Diseases

On June 13, the U.S. Food and Drug Administration (FDA) accepted for review a new supplemental biologics license application (sBLA) for recombinant human papillomavirus (HPV) 9-valent vaccine (Gardasil  9). The application is seeking approval for an expanded age...

Statement From FDA Commissioner on Agency Efforts to Advance the Patient Voice in Medical Product Development and Regulatory Decision-Making

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, recently issued the following statement: Over the past decade, advances in our understanding of the basic biology of serious and life-threatening diseases has led to the development and FDA approval of targeted treatments for ...

colorectal cancer
cost of care

AMA Plans Advocacy Outreach to Expand Colorectal Screening

Building on the efficacy of colorectal cancer screening, the American Medical Association (AMA) endorsed a plan at its Annual Meeting to work with physicians and payers to make the screening more available and affordable. Challenges with insurance coverage remain a barrier to colorectal cancer...

Ibrutinib in Relapsed or Refractory Follicular Lymphoma

In the phase II DAWN study reported in the Journal of Clinical Oncology, Gopal et al found that ibrutinib (Imbruvica) produced a response in a minority of patients with relapsed or refractory follicular lymphoma. Study Details In the study, 110 patients with ≥ 2 prior lines of treatment...

Suboptimal Use of Initial Chemotherapy in Newly Diagnosed AML

In a study of National Cancer Database data reported in Blood Advances, Bhatt et al found that 25% of patients with newly diagnosed acute myeloid leukemia (AML) did not receive initial chemotherapy, despite evidence that chemotherapy is associated with a survival benefit and improvement in symptoms ...

DNA Test Identifies Men With Sixfold Increased Risk of Prostate Cancer

A major new study of more than 140,000 men has identified 63 new genetic variations in the DNA code that increase the risk of prostate cancer. These findings were published by Schumacher et al in Nature Genetics. Researchers devised a new test combining these single-letter genetic variants with...

Parents See Cancer Prevention Potential as Best Reason for HPV Vaccination

Parents of adolescents believed that the potential to prevent certain types of cancer is the best reason for their children to receive the human papillomavirus (HPV) vaccine, whereas other reasons health-care providers often give were far less persuasive. Findings from this study were published by...

Journal of Oncology Practice Launches New Blog to Facilitate Discussions on Care Delivery Topics

The Journal of Oncology Practice (JOP) has launched a new care delivery blog, JOP DAiS (Discussion & Analysis in Short), to serve as a forum for commentary and analysis on issues affecting the mechanisms of oncology care delivery. This new platform will be a way to collaborate, debate, and...

ASCO/CAP Clinical Practice Guideline Focused Update on HER2 Testing in Breast Cancer

As reported in the Journal of Clinical Oncology by Antonio C. Wolff, MD, of Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, and colleagues, ASCO and the College of American Pathologists (CAP) have issued a clinical practice guideline focused update on HER2 testing in breast cancer....

Activity of Ivosidenib in IDH1-Mutated Relapsed or Refractory Acute Myeloid Leukemia

As reported at the 2018 ASCO Annual Meeting and in The New England Journal of Medicine by DiNardo et al, early-phase testing has shown activity of ivosidenib, an oral small-molecule inhibitor of mutant IDH1, in patients with IDH1-mutated relapsed or refractory acute myeloid leukemia (AML). IDH1...

EHA 2018: Tazemetostat in Relapsed or Refractory Follicular Lymphoma

Positive interim data were recently presented from an ongoing phase II study of tazemetostat—a potent, selective, orally available EZH2 inhibitor—as a monotherapy for patients with relapsed or refractory follicular lymphoma. The data, presented by Salles et al at the 23rd Annual...

EHA 2018: Ruxolitinib Reduces Risk of Thrombosis, Death in Patients With Polycythemia Vera

A new comparison study showed that among polycythemia vera patients who were resistant or intolerant to hydroxyurea, those treated with ruxolitinib (Jakavi) had a significantly reduced risk of thrombosis and death compared to those who received best available therapy. The study findings are based...

EHA 2018: Single-Agent Quizartinib vs Chemotherapy in Relapsed or Refractory AML

Results from the phase III QuANTUM-R study of single-agent quizartinib in relapsed or refractory acute myeloid leukemia (AML) were presented by Cortes et al at the 23rd Annual Congress of the European Hematology Association (EHA) (Abstract LB2600). Study Findings QuANTUM-R study results showed...

EHA 2018: Undetectable MRD Rates With Venetoclax Plus Rituximab in Relapsed or Refractory CLL

Investigational data from a new analysis of undetectable minimal residual disease (MRD) rates from the phase III MURANO trial of venetoclax (Venclexta, a first-in-class oral B-cell lymphoma 2 [BCL2] inhibitor) in combination with rituximab (Rituxan) in patients with relapsed or refractory chronic...

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...

Activity of the PD-1 Inhibitor Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma

As reported at the 2018 ASCO Annual Meeting (Abstract 9519) and in The New England Journal of Medicine by Migden et al, results of early-phase testing show activity of the programmed cell death protein 1 (PD-1) inhibitor cemiplimab in advanced cutaneous squamous cell carcinoma. Currently, no...

EHA 2018: Tisagenlecleucel Demonstrates More Than 1-Year Durability of Response in Adults With Relapsed or Refractory DLBCL

Fourteen-month results from the JULIET clinical trial showed ongoing durable responses are achievable with tisagenlecleucel (Kymriah) when administered to adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This updated analysis was presented by Borchmann et al at ...

EHA 2018: Elotuzumab Plus Pomalidomide and Low-Dose Dexamethasone vs Pomalidomide/Dexamethasone Alone in Relapsed or Refractory Multiple Myeloma

The ELOQUENT-3 trial, an international phase II study evaluating the addition of elotuzumab (Empliciti) to pomalidomide (Pomalyst) and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma, achieved its primary endpoint, showing a statistically significant and clinically...

EHA 2018: Obinutuzumab or Rituximab Plus Chlorambucil in CLL

Data from the final analysis of the CLL11 study evaluating obinutuzumab (Gazyva)-based treatment in previously untreated chronic lymphocytic leukemia (CLL) was presented by Goede et al during the Presidential Symposium at the 23rd Annual Congress of the European Hematology Association (EHA)...

EHA 2018: Alvocidib in Patients With Relapsed or Refractory MCL-1–Dependent AML

Preliminary data from Zella 201—an ongoing phase II study evaluating the efficacy and safety of alvocidib, a potent cyclin-dependent kinase 9 (CDK9) inhibitor, in combination with cytarabine and mitoxantrone in patients with relapsed or refractory MCL-1–dependent acute myeloid leukemia...

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...

Final Overall Survival Analysis of First-Line Crizotinib vs Chemotherapy in Advanced ALK-Positive NSCLC

As reported by Solomon and colleagues in the Journal of Clinical Oncology, the final overall survival results of the phase III PROFILE 1014 trial showed evidence of survival benefit of first-line crizotinib (Xalkori) vs chemotherapy in advanced ALK-positive non–small cell lung cancer (NSCLC). ...

breast cancer
solid tumors

FDA Clears Expanded Indication of Scalp-Cooling System

Paxman’s advanced scalp-cooling system has now been cleared by the US Food and Drug Administration (FDA) for use during treatment of patients with solid tumors. The system is now indicated to reduce the likelihood of chemotherapy-induced alopecia in cancer patients with solid tumors such as...

palliative care
issues in oncology

AMA Rejects Recommendation to Reaffirm Opposition to Medical Aid in Dying

On June 11, the American Medical Association (AMA) House of Delegates voted 56% to 44% to reject a report by its Council on Ethical and Judicial Affairs (CEJA) that recommended the AMA maintain its Code of Medical Ethics’ opposition to medical aid in dying. Instead, the House of Delegates...

head and neck cancer
survivorship

Male Thyroid Cancer Survivors Face 50% Higher Risk of Cardiovascular Disease Than Women

Male thyroid cancer survivors have a nearly 50% higher risk of developing cardiovascular disease than women within 5 years of cancer diagnosis, according to a new study published by Park et al in the Journal of Clinical Endocrinology & Metabolism. More than 62,000 new cases of thyroid cancer...

Informed Consent Issues for Patients With Advanced Cancer in Phase I Trials

As reported by Hlubocky et al in the Journal of Oncology Practice, oncologists may not provide patients with advanced cancer participating in phase I clinical trials with sufficient information about prognosis and purposes of phase I testing during enrollment discussions. Study Details The study...

breast cancer
survivorship

Low-Fat Dietary Intervention and Overall Survival After Breast Cancer Diagnosis

In an analysis from the Women’s Health Initiative (WHI) trial reported in JAMA Oncology, Chlebowski et al found that overall survival after the diagnosis of incident breast cancer was improved in women in the reduced-fat dietary intervention group vs control group, reflecting reduced...

Prophylactic Cranial Irradiation in Stage III NSCLC

In a Dutch phase III trial reported in the Journal of Clinical Oncology, De Ruysscher et al found that prophylactic cranial irradiation (PCI) prevented symptomatic brain metastases vs observation in patients with stage III non–small cell lung cancer (NSCLC) receiving treatment with curative...

FDA and EMA Accept Regulatory Submissions for Review of Talazoparib for Patients With Germline BRCA-Mutated Metastatic Breast Cancer

The U.S. Food and Drug Administration (FDA) recently accepted for filing and granted Priority Review designation a new drug application for talazoparib. The submission is based on results from the EMBRACA trial, which evaluated talazoparib vs chemotherapy in patients with germline BRCA-mutated,...

Eating a High-Quality Diet Could Decrease Cancer Survivors’ Risk of Death by 65%

Cancer survivors who consumed a balanced, nutrient-dense diet had a 65% lower risk of dying from cancer than survivors who ate a poor-quality diet, according to findings published by Deshmukh et al in JNCI Cancer Spectrum. The study suggests that more than focusing on any particular food group,...

ASCO Guideline for Geriatric Oncology: Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Chemotherapy

As reported in the Journal of Clinical Oncology by Supriya G. Mohile, MD, of the University of Rochester Medical Center, and colleagues, ASCO has produced a guideline on the practical assessment and management of vulnerabilities in geriatric patients receiving chemotherapy. To develop the...

Total Neoadjuvant Therapy for Borderline Resectable Pancreatic Adenocarcinoma

In a single-institution phase II trial reported in JAMA Oncology, Murphy et al found that total neoadjuvant therapy with FOLFIRINOX (fluorouracil [5-FU], irinotecan, and oxaliplatin) and individualized chemoradiotherapy was associated with a high R0 resection rate and good outcomes in patients with ...

Study Finds Recent-Onset Type 2 Diabetes May Be Early Manifestation of Pancreatic Cancer

According to the American Cancer Society, pancreatic cancer is one of the most deadly cancers, with an overall 5-year survival rate of just 8%, mainly because the vast majority of patients, about 80%, are diagnosed at a late stage of disease. Research has shown that identification of high-risk ...

lung cancer
multiple myeloma

Studies of Daratumumab in Combination With Anti–PD-L1 Agents Stopped

On May 26, Genmab A/S announced that following a planned review, the Data Monitoring Committee (DMC) has recommended that the phase Ib/II study (CALLISTO/LUC2001) of daratumumab (Darzalex) in combination with the anti–programmed cell death ligand 1 (PD-L1) antibody atezolizumab (Tecentriq) vs ...

AMA Releases New Physician Guide on Caring for the Caregiver

Every day in their treatment rooms, physicians encounter individuals who are making profound sacrifices to help a loved one who is seriously ill, often at the expense of their own well-being. To help physicians understand the day-to-day challenges and risk of burnout faced by informal caregivers,...

breast cancer
issues in oncology
survivorship

Study Finds Breast Cancer Survivors Are Not Getting Recommended Number of Mammograms Postsurgery

Breast cancer survivors are not getting the recommended level of screening postsurgery, according to a study by Ruddy et al in JNCCN–Journal of the National Comprehensive Cancer Network. The study was led by Kathryn Ruddy, MD, MPH, Director of Cancer Survivorship for the Department of...

Opportunities, Issues, and Challenges for Biosimilars in Oncology

In an article in The New England Journal of Medicine, Lyman et al reviewed opportunities, issues, and challenges posed by the advent of biosimilar medications, focusing on biosimilars in cancer treatment. Although these agents could help to meet the health-care goals of high quality care with cost...

Lung Cancer Incidence in Young Women vs Men in the United States

In a study reported in The New England Journal of Medicine, Jemal et al found that the incidence of lung cancer in young white and Hispanic women is now higher than that in men in the US. Study Details The study involved analysis of data from the North American Association of Central Cancer...

breast cancer
lung cancer

Characteristics and Screening of Brain Metastases in Breast Cancer and NSCLC

In a research letter published in JAMA Oncology, Cagney et al found that brain metastases were more advanced and more likely to be symptomatic in patients with breast cancer compared to patients with non–small cell lung cancer (NSCLC). Current guidelines recommend magnetic resonance imaging...

FDA Expands Approval of Pembrolizumab to Include New Lymphoma Indication

Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma or those who have relapsed after two or more prior lines of therapy. KEYNOTE-170...

FDA Approves Bevacizumab Plus Chemotherapy in Advanced Ovarian Cancer Following Initial Surgery

Today, the U.S. Food and Drug Administration (FDA) approved bevacizumab (Avastin) in combination with chemotherapy (carboplatin and paclitaxel) followed by bevacizumab as a single agent for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection....

Barbara L. McAneny, MD, Inaugurated as 173rd President of the AMA

Barbara L. McAneny, MD, an oncologist from Albuquerque, has been sworn in as the 173rd President of the American Medical Association (AMA). She will focus her tenure on the AMA’s three strategic arcs: attacking the dysfunction in health care by removing obstacles and barriers that interfere...

ESMO Emphasizes Importance of Cancer on the Global Health Agenda at the 71st World Health Assembly

At the 71st World Health Assembly in Geneva, the European Society for Medical Oncology (ESMO) delivered two statements positioning cancer as a priority on the global agenda of the World Health Organization (WHO). Presenting its recommendations for action to the international community,...

leukemia
lymphoma

iLLUMINATE Trial of Ibrutinib Plus Obinutuzumab for First-Line Therapy of CLL/SLL Meets Primary Endpoint

The phase III iLLUMINATE (PCYC-1130) trial recently met its primary endpoint of improvement in progression-free survival. The study evaluated ibrutinib (Imbruvica) in combination with obinutuzumab (Gazyva) in patients with previously untreated chronic lymphocytic leukemia or small lymphocytic...

ASCO Clinical Practice Guideline Focused Update: Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer

As reported by Neelima Denduluri, MD, of US Oncology Network, Virginia Cancer Specialists, and colleagues in the Journal of Clinical Oncology, ASCO has issued a focused update on the clinical practice guideline on optimal chemotherapy and targeted therapy in early breast cancer. To develop the...

Analysis of Intracranial Response to Brigatinib in ALK-Positive NSCLC With Brain Metastases

In an analysis of two clinical trials reported in the Journal of Clinical Oncology, Camidge et al found that brigatinib (Alunbrig) produced high intracranial response rates and good intracranial progression-free survival in patients with ALK-positive non–small cell lung cancer (NSCLC) and...

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...

FDA Approves Pembrolizumab for Previously Treated Recurrent or Metastatic PD-L1–Expressing Cervical Cancer

On June 12, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with recurrent or metastatic cervical cancer and disease progression on or after chemotherapy whose tumors express programmed cell death ligand 1 (PD-L1) [Combined Positive Score...

Older Patients With Melanoma Fare Better on Anti–PD-1 Immunotherapy Than Younger Patients

Recent research has shown that the tumor microenvironment in older patients promoted melanoma metastasis and resistance to targeted therapy with a BRAF inhibitor. Now, a new study investigating the relationships among age, response to anti–programmed cell death protein 1 (PD-1)...

Cancer Prevention Report Shows Consensus Among Global Experts on 10 Steps to Reduce Risk

An internationally released comprehensive analysis of research on lifestyle factors and cancer prevention confirms the critical links between cancer diagnoses and diet, physical activity, and weight. Independent experts from across the globe reviewed decades of scientific evidence to develop the...

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