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FDA Restricts Use of Pembrolizumab or Atezolizumab to Treat Urothelial Cancer Due to Efficacy Concerns in Some Patients

As of June 20, the U.S. Food and Drug Administration (FDA) has restricted the use of pembrolizumab (Keytruda) and atezolizumab (Tecentriq) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy. The restriction results from a...

FDA Approves Encorafenib and Binimetinib in Combination for Unresectable or Metastatic Melanoma With BRAF Mutations

Today, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi) and binimetinib (Mektovi) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Approval was based on the randomized,...

FDA Accepts Supplementary PMA for Review of BRACAnalysis CDx as a Companion Diagnostic to Talazoparib in Metastatic Breast Cancer

The U.S. Food and Drug Administration (FDA) recently accepted a supplementary premarket approval (PMA) application for BRACAnalysis CDx to be used as a companion diagnostic with the poly ADP ribose polymerase (PARP) inhibitor talazoparib. The new drug application (NDA) for...

JAK Inhibitor Treatment for Myelofibrosis May Be Associated With Development of Aggressive Lymphomas

Austrian researchers have discovered that a small number of patients taking targeted drugs known as Janus kinase (JAK) inhibitors to treat myelofibrosis may develop aggressive lymphomas. They also speculate that screening for a preexisting B-cell clone before starting therapy may help prevent this...

In Continued Effort to Address Physician Burnout, AMA Adopts Policy to Improve Physician Access to Mental Health Care

With growing concern among the medical community and the public regarding physician and medical student depression, burnout, and suicide, the American Medical Association (AMA) adopted policy during its Annual Meeting that continues its efforts aimed at improving physician access to mental health...

FDA Expands Approval of Pembrolizumab for First-Line Treatment of NSCLC

The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to the immune checkpoint inhibitor pembrolizumab (Keytruda) for use in combination with chemotherapy as a first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC). KEYNOTE-021 This...

Inside Story on the Genesis of Teen Cancer America

THANK YOU for publishing the excellent article “We Need to Fill the Gap Between Pediatric and Adult Oncology Care” by Sarah Stream (as told to Jo Cavallo) in the March 25, 2018, issue of The ASCO Post. Sarah’s story and her connection to Teen Cancer America actually go much deeper than she reported ...

gynecologic cancers

FDA Approves Bevacizumab in Combination With Chemotherapy for Ovarian Cancer

ON JUNE 13, 2018, the U.S. Food and Drug Administration (FDA) approved bevacizumab (Avastin) for the treatment of patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV...

gynecologic cancers
lymphoma

Pembrolizumab Receives FDA Approval for Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma, Advanced Cervical Cancer

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 who have relapsed after two or more prior lines of therapy on June 13, 2018. The newest ...

lymphoma

I’m Proud to Have Contributed to the FDA Approval of CAR T-Cell Therapy

When I was diagnosed with diffuse large B-cell lymphoma (DLBCL) in 2013, I used to joke that if I had to get cancer, this wasn’t a bad one to have. At just 32, I was otherwise healthy, and my prognosis for a cure was good, according to my oncologist. So I felt confident that once I underwent...

Colorectal Cancer Alliance Announces Available Research Funding

THE COLORECTAL CANCER Alliance has announced up to $775,000 in available funding for up to five grants supporting research in young-onset colorectal cancer, rectal cancer, and colorectal cancer prevention. The Colorectal Cancer Alliance is committed to investing $10 million in research by 2021,...

Jens Hillengass, MD, Named Chief of Myeloma at Roswell Park

JENS HILLENGASS, MD, has been announced as the new Chief of Myeloma of the Roswell Park Comprehensive Cancer Center. As part of his new role, Dr. Hillengass will continue his research on hematologic diseases, including multiple myeloma and its precursor diseases.  A scientist with more than 15...

WHO Names St. Jude Its First Collaborating Center for Childhood Cancer

THE WORLD HEALTH ORGANIZATION (WHO) has designated St. Jude Children’s Research Hospital as the first WHO Collaborating Center for Childhood Cancer. With this collaboration, both organizations aim to expand efforts to develop strategies to strengthen the global resources, organization, and planning ...

Researchers at Baylor Awarded Multiple Grants to Study Treatment Resistance in Breast Cancer

TO BETTER UNDERSTAND the causes of resistance to treatment in estrogen receptor–positive breast cancer, the Department of Defense has awarded researchers at Baylor College of Medicine multiple grants to study gene anomalies in estrogen receptor–positive breast cancer that are associated with...

lung cancer

Disparities Found in Lung Cancer Care, Survival in United States vs England

DESPITE STEADY declines in death rates in recent years, lung cancer remains the leading cause of cancer deaths in wealthy countries. In a study published by Anita Andreano, MD, of the University of Milan-Ciocco, and colleagues in the Journal of Thoracic Oncology,1 Yale researchers collaborated with ...

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...

Harvard Business School Launches Initiative to Accelerate Precision Medicine in Oncology

THE HARVARD BUSINESS School Kraft Precision Medicine Accelerator, a multidisciplinary initiative with aims to advance precision medicine, focuses on four workstreams: Direct to Patient, Data & Analytics, Clinical Trials, as well as Venture and Investment. It was recently announced that under...

Richard D. Schulick, MD, MBA, Named Director of University of Colorado Cancer Center

RICHARD D. SCHULICK, MD, MBA, a cancer surgeon and administrative leader, has been named Director of the University of Colorado Cancer Center, a consortium of three universities and three academic teaching hospitals. The University of Colorado Cancer Center is the hub of cancer research in the...

Steven A. Rosenberg, MD, PhD, Receives American College of Surgeons Jacobson Innovation Award

THE 2018 JACOBSON INNOVATION AWARD of the American College of Surgeons was recently presented to Steven A. Rosenberg, MD, PhD, Chief of the Surgery Branch at the National Cancer Institute (NCI) as well as Professor of Surgery at the Uniformed Services University of Health Sciences and at the...

palliative care

How Learning What’s on Your Patient’s Bucket List May Improve Care

It may sound too good to be true, but asking patients a simple question about what is on their bucket list can actually spark a dialogue about how best to make their cancer care and survivorship fit into their life plans, as well as be an effective way to identify their end-of-life care goals,...

ESMO Prioritizes Cancer Care at 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, ESMO...

issues in oncology
palliative care

Voluntarily Stopping Eating and Drinking Is Legal—and Ethical—for Terminally Ill Patients Looking to Hasten Death

Terminally ill patients with cancer will sometimes ask their clinicians for help with assisted or hastened death.1 Although palliative care and hospice care can usually address the concerns of most patients, some have physical or existential suffering that is refractory to comfort and supportive...

leukemia

Patients With AML Have Reduced Risk of Early Mortality at NCI-Designated Cancer Centers

RESEARCHERS AT the University of California (UC), Davis, have shown that patients with acute myeloid leukemia (AML) who received their care at a National Cancer Institute (NCI) cancer center in California had a dramatically reduced risk of early mortality. Using data from the California Cancer...

Folakemi Odedina, PhD, Awarded Fellowship for Oncology Clinical Trials in Africa

FOLAKEMI ODEDINA, PhD, Professor of Pharmacotherapy and Translational Research at the University of Florida College of Pharmacy, has been awarded a 2018 Carnegie African Diaspora Fellowship to help expand oncology clinical trials in Africa.  Dr. Odedina will travel to South Africa to collaborate...

Dan Theodorescu, MD, PhD, Appointed Director of Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai

DAN THEODORESCU, MD, PhD, has been named Director of the Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai, a position he will assume starting July 1, 2018.  Dr. Theodorescu, a translational cancer researcher and expert in bladder cancer, will direct the oncology enterprise at...

solid tumors
prostate cancer

Prostate Cancer Therapy in Evolution: Time to Rethink and Redirect?

The ASCO updated guidelines on the treatment of metastatic non-castrate prostate cancer penned by Morris and his colleagues1 provide valuable information annotated to the strengths of evidence in recently reported prostate cancer studies. CHAARTED, GETUG-AFU 15, LATITUDE, and STAMPEDE have...

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...

11 New Institutions Join AACR Project GENIE Consortium

The number of institutions participating in the American Association for Cancer Research (AACR) initiative, AACR Project Genomics Evidence Neoplasia Information Exchange (GENIE), has increased by 11 participants. The 11 new institutions of the AACR Project GENIE consortium and their related cancer...

solid tumors
gastrointestinal cancer

Optimizing Biologics in Metastatic Colon Cancer

Biologics are credited with increasing median overall survival in colorectal cancer to approximately 30 months. Their optimal use was discussed by Axel Grothey, MD, Professor of Oncology at the Mayo Clinic, Rochester, Minnesota, in an article he coauthored for the Journal of Oncology Practice 1...

solid tumors
head and neck cancer

Esomeprazole With Aspirin in Patients With Barrett’s Esophagus

An updated analysis of a randomized phase III trial showed that taking a high dose of esomeprazole with low-dose aspirin for at least 7 years may moderately reduce the risk of developing high-grade dysplasia or esophageal cancer and may delay death from any cause in people with Barrett’s esophagus. ...

solid tumors
breast cancer

Richard J. Bleicher, MD, FACS, Appointed Vice Chair of SSO’s Breast Fellowship Program Directors Committee

Richard J. Bleicher, MD, FACS, Professor of Surgical Oncology at Fox Chase Cancer Center, has been appointed Vice Chair of the Breast Fellowship Program Directors Committee of the Society of Surgical Oncology (SSO). In his new leadership role within SSO, Dr. Bleicher will be involved in the breast ...

Expert Point of View: Kenneth C. Anderson, MD, FASCO, Adam D. Cohen, MD, Craig Hofmeister, MD, MPH, and Bruce Cheson, MD

Kenneth C. Anderson, MD, FASCO, of Dana-Farber Cancer Institute, Boston, noted that the iNNOVATE trial is the first randomized comparison of ibrutinib (Imbruvica) plus rituximab (Rituxan) vs “a very active control—rituximab—to which 50% of patients responded.” The study showed that “the...

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...

solid tumors
skin cancer

The Raven

The call from the dermatologist came at noon on Good Friday, just after my wife left with our two young daughters for a week on her family’s tree farm in Northern Michigan. I was on call for the hospital inpatient leukemia service, so I could not join them. When the dermatologist solemnly began,...

hematologic malignancies
leukemia

Minimal Residual Disease Testing in AML: Still a Shifting Target

Testing for minimal residual disease (MRD) has become an established part of the management of acute lymphoblastic leukemia (ALL), but in acute myeloid leukemia (AML), the technology still warrants validation. To address issues and set new standards, the European LeukemiaNet Working Party recently ...

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...

Expert Point of View: Colin D. Weekes, MD, PhD and Andrew Epstein, MD

Colin D. Weekes, MD, PhD, of Massachusetts General Hospital and Harvard Medical School, called the results of the PRODIGE trial “practice-changing.” Dr. Weekes was the invited discussant of the study and was interviewed by The ASCO Post. “The magnitude of effect is beyond what we have ever seen in...

solid tumors
pancreatic cancer

Adjuvant Modified FOLFIRINOX Yields Unprecedented Survival in Pancreatic Cancer

Adjuvant treatment with modified FOLFIRINOX resulted in the longest overall survival yet reported for patients with resected pancreatic cancer, according to the results of the phase III Unicancer GI PRODIGE 24/CCTG PA.6 trial, presented at the 2018 ASCO Annual Meeting.1 With adjuvant modified...

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...

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...

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