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FDA Accepts sBLA, Grants Priority Review for Tisagenlecleucel in Adults With DLBCL

Today, the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental Biologics License Application (sBLA) for tisagenlecleucel (Kymriah) suspension for intravenous infusion (formerly CTL019) for the treatment of adult patients with relapsed or refractory diffuse large...

Improved Overall and Progression-Free Survival With First-Line Pembrolizumab in Combination With Pemetrexed and Cisplatin or Carboplatin in NSCLC

The phase III KEYNOTE-189 trial—investigating pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and cisplatin or carboplatin for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC)—met its dual primary endpoints of...

issues in oncology
cost of care

ACCC 2017 Survey Shows Cost of Treatment Is Top Threat to Cancer Program Growth

The Association of Community Cancer Centers (ACCC) 8th annual Trending Now in Cancer Care survey, conducted in partnership with Advisory Board’s Oncology Roundtable, has identified current and emerging trends across U.S. cancer programs. When asked to identify the top threats to future cancer ...

Arsenic Trioxide With Tretinoin for First-Line Treatment of Acute Promyelocytic Leukemia Approved by the FDA

On January 15, the U.S. Food and Drug Administration (FDA) approved the use of arsenic trioxide (Trisenox) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17)...

ASCO GI 2018: Liquid Biopsy Test May Detect Early-Stage Colorectal Cancer

A new study has found that a test that identifies circulating tumor cells (CTCs) present in the bloodstream can detect colorectal cancer at an early stage, with accuracy ranging from 84% to 88%. Most prior studies using CTCs have been able to detect late-stage colorectal cancer, and this study is...

FDA Approves Afatinib for Previously Untreated, Metastatic NSCLC With Other Nonresistant EGFR Mutations

On January 12, 2018, the U.S. Food and Drug Administration (FDA) granted approval to afatinib (Gilotrif) for a broadened indication in first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have nonresistant epidermal growth factor receptor (EGFR)...

lung cancer
issues in oncology

Study Finds Adolescents Using Alternative Tobacco Products Are More Likely to Smoke 1 Year Later

Nonsmoking adolescents who use e-cigarettes, smokeless tobacco, or tobacco water pipes are more likely to start smoking conventional cigarettes within a year, according to new research by the University of California, San Francisco (UCSF). Findings were published by Watkins et al in JAMA...

Estrogen-Mimicking Compounds Found in Many Foods May Reduce Effectiveness of Breast Cancer Treatment

Scientists from The Scripps Research Institute (TSRI) have found that two estrogen-mimicking compounds found in many foods appear to potently reverse the effects of palbociclib/letrozole, a popular drug combination for treating breast cancer. The study, published by Warth et al in Cell Chemical...

CAP Guideline Details HPV Testing in Head and Neck Carcinomas

Patients with certain head and neck cancers who test positive for high-risk types of human papillomavirus (HPV) have a better prognosis and may need less aggressive treatment. To help ensure that patients with these cancers are accurately diagnosed and effectively treated, the College of...

FDA Approves Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer

Today, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib (Lynparza), a poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who have been...

Study Finds Desmoplastic Melanoma Highly Responsive to PD-1/PD-L1 Blockade

Desmoplastic melanoma is a rare subtype of melanoma that is commonly found on sun-exposed areas, such as the head and neck, and usually seen in older patients. Treatment is difficult, as these tumors are often resistant to chemotherapy and lack actionable mutations commonly found in other types of...

Chemoradiation in Elderly Patients With Stage III NSCLC Improves Overall Survival

Elderly patients with stage III non–small cell lung cancer (NSCLC) showed improved overall survival when treated with chemoradiation compared to definitive radiation alone, according to findings published by Miller et al in the Journal of Thoracic Oncology. NSCLC constitutes between...

Study Finds Gene-Expression Profile Testing for Breast Cancer Less Cost-Effective in Real-World Practice

The most commonly used gene expression profile test used to help predict breast cancer recurrence may not be as cost-effective as once thought, say a team of researchers led by scientists from Georgetown Lombardi Comprehensive Cancer Center. Their study, published by Chandler et al in the Journal...

breast cancer
colorectal cancer
lung cancer
skin cancer
issues in oncology

Growing Socioeconomic and Racial Disparities in Management of Brain Metastases

Increasing use of a potentially life-saving treatment for metastatic cancer is leaving too many vulnerable patients behind, according to a new study from Yale Cancer Center/Smilow Cancer Hospital published by Kann et al in JNCCN – Journal of the National Comprehensive Cancer Network. The...

Lenvatinib and Pembrolizumab Combination Receives Breakthrough Therapy Designation for Advanced Renal Cell Carcinoma

On January 9, Eisai and Merck announced that they received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for Eisai's multiple receptor tyrosine kinase inhibitor lenvatinib (Lenvima) in combination with Merck's anti–programmed cell death protein 1...

Adjuvant Pembrolizumab Improves Recurrence-Free Survival in Stage III Resected High-Risk Melanoma

On January 8, Merck and the European Organisation for Research and Treatment of Cancer (EORTC) announced that the phase III EORTC1325/KEYNOTE-054 trial investigating pembrolizumab (Keytruda) as monotherapy for surgically resected high-risk melanoma met its primary endpoint of recurrence-free...

New Cancer Model Shows Genomic Link Between DCIS and IDC Breast Cancer Types

A new genetic-based model may explain how ductal carcinoma in situ (DCIS) progresses to a more invasive form of cancer, say researchers at The University of Texas MD Anderson Cancer Center. The study provides new insight into how DCIS leads to invasive ductal carcinoma (IDC) and provides a clearer...

Cancer Statistics 2018: U.S. Cancer Mortality Continues Decades-Long Drop

The cancer death rate dropped 1.7% from 2014 to 2015, continuing a drop that began in 1991 and has reached 26%, resulting in nearly 2.4 million fewer cancer deaths during that time. The data is reported in “Cancer Statistics, 2018,” the American Cancer Society’s...

FDA Approves Denosumab for the Prevention of Skeletal-Related Events in Patients With Multiple Myeloma

Today, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for denosumab (Xgeva) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients...

Patients With SCLC Face Barriers to Receiving Standard-of-Care Treatment

Despite decades of clinical research establishing chemotherapy with thoracic radiation as the standard of care for the initial management of nonmetastatic small cell lung cancer (SCLC), a large percentage of U.S. patients do not receive these treatments, and in turn have lower overall survival,...

Treatment With Carfilzomib May Lead to Cardiovascular Toxicity in Patients With Multiple Myeloma

The proteasome inhibitor carfilzomib (Kyprolis) has taken on an increasing role in the treatment of multiple myeloma, but new research from the Abramson Cancer Center of the University of Pennsylvania shows the therapy may come with the risk of cardiovascular problems in a higher than expected...

Ribociclib Receives FDA Breakthrough Therapy Designation in Premenopausal Women With Hormone Receptor–Positive, HER2-Negative Breast Cancer

On January 3, ribociclib (Kisqali) received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for initial endocrine-based treatment of pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer in combination with...

FDA Accepts sBLA, Grants Priority Review for Brentuximab Vedotin in Advanced Hodgkin Lymphoma

On January 2, the U.S. Food and Drug Administration (FDA) accepted for filing a supplemental Biologics License Application (sBLA) for brentuximab vedotin (Adcetris) in combination with chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. The FDA also...

skin cancer

FDA Accepts sNDA, Grants Priority Review to Adjuvant Dabrafenib/Trametinib in BRAF V600E/K Mutation–Positive Melanoma

On December 22, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) and granted Priority Review designation to dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with BRAF V600E...

kidney cancer

FDA Grants Breakthrough Therapy Designation to Combination of Avelumab and Axitinib in Advanced Renal Cell Carcinoma

On December 21, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to avelumab (Bavencio) in combination with axitinib (Inlyta) for treatment-naive patients with advanced renal cell carcinoma. “A combination approach with an immunotherapy, whose activity may ...

leukemia

FDA Updates Nilotinib Label With Information on Discontinuing Treatment in Certain Patients With Early-Phase CML After Sustained Response

On December 22, the U.S. Food and Drug Administration (FDA) updated the product label for nilotinib (Tasigna) to include information for providers about how to discontinue the drug in certain patients. Nilotinib, first approved by the FDA in 2007, is indicated for the treatment of patients with...

breast cancer

FDA Clears Stereotactic Radiotherapy System for Use in Treating Breast Cancer

On December 22, the U.S. Food and Drug Administration (FDA) cleared a new noninvasive stereotactic radiotherapy system intended for use in treating cancer in breast tissue. “With [this] clearance, patients will have access to a treatment option that provides greater accuracy in delivering...

Oncology World Mourns the Loss of Jimmie C. Holland, MD, Founder, Field of Psycho-Oncology

Jimmie C. Holland, MD, died suddenly on December 24, 2017, at the age of 89 years. Dr. Holland was the Attending Psychiatrist and Wayne E. Chapman Chair at Memorial Sloan Kettering (MSK) Cancer Center and Professor of Psychiatry, Weill Medical College of Cornell University in New York....

Harborside Partners With MAZ to Launch OncologyGo, Cancer Resource for Mobile Devices and TV

Media technology company, MAZ, has partnered with Harborside, a medical communications company based in Huntington, New York, to launch OncologyGo, a streaming-event coverage and video content app for specialists in oncology health care available on Apple TV, Roku, FireTV, and iOS. Harborside...

issues in oncology

Is Medical Assistance in Dying Compassionate Care?

Suicidal ideation while receiving end-of-life cancer care is not unusual but can often be reversed by palliative and psychosocial oncology interventions. That said, there are patients who, even after intensive interventions, request medical assistance in dying. Physician-assisted death has been a...

Howard A. ‘Skip’ Burris III, MD, FACP, FASCO, Elected ASCO President for 2019–2020 Term

Howard A. “Skip” Burris III, MD, FACP, FASCO, a long-time member and volunteer, has been elected to serve as the President of ASCO for the term beginning in June 2019. He will take office as President-Elect during the ASCO Annual Meeting in Chicago in June 2018. Additionally, five members were...

Alcohol and Cancer Risk Reconsidered

Having valued communications from ASCO since its birth, I was disappointed by the Society’s position on alcohol consumption and cancer risk, as published in a recent issue of the Journal of Clinical Oncology (JCO)1 and summarized in the November 25 issue of The ASCO Post. The statement seems to me ...

solid tumors
head and neck cancer

Helping Patients With Head and Neck Cancer and Their Caregivers Face Treatment-Associated Challenges

Head and neck cancer remains one of the most challenging clinical presentations faced by the oncology community. Patients must not only face a potentially lethal disease, but must also cope with treatments that often result in significant side effects. To gain a better understanding on the...

Colorectal Cancer Mortality Rates

In a research letter to JAMA, Rebecca L. Siegel, MPH, of the American Cancer Society, and colleagues reported that overall colorectal cancer mortality rates have declined in the United States between 1970 and 2004 in patients aged 20 to 54 years. Between 2004 and 2014, colorectal cancer mortality...

Adding Bevacizumab to Chemotherapy in Advanced Cervical Cancer

As reported in The Lancet by Krishnansu S. Tewari, MD, of the University of California-Irvine Medical Center, and colleagues, the final overall survival results of the phase III Gynecologic Oncology Group 240 trial show continued benefit of the addition of bevacizumab (Avastin) to chemotherapy in...

Maximiliano D’Angelo, PhD, Receives ACS Research Grant

Maximiliano D’Angelo, PhD, Assistant Professor at Sanford Burnham Prebys Medical Discovery Institute, has received a 4-year, $792,000 Research Scholar Grant from the American Cancer Society (ACS). The ACS awards Research Scholar Grants for promising research projects that may lead to the...

ASCO Remembers Cancer Research Advocate Patrick Gavin, RPh

ASCO and the oncology community mourn the loss of Patrick Gavin, RPh, who passed away on December 18, 2017, at age 68. A 10-year cancer survivor, Mr. Gavin was a dedicated advocate for patients with cancer and for cancer research. Mr. Gavin was a pharmacist by training and spent much of his career ...

Samuel Oschin Comprehensive Cancer Institute Receives 3-Year Accreditation From ACS

The Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai has been honored with a 3-year accreditation with commendation from the American College of Surgeons (ACS). The accreditation is recognized by the National Cancer Institute, Centers for Medicare & Medicaid Services, the Joint...

Expect Questions About Link Between Alcohol and Cancer

With headlines such as “Cutting back on alcohol can prevent cancers”1 and “Even light drinking may raise your cancer risk,”2 media reports may be generating questions from patients about the ASCO statement summarizing evidence linking alcohol to an increased risk of cancer.3 “What I personally...

solid tumors
breast cancer

27 Breast Oncologists Recognized on Forbes’ ‘Physician Honor Roll’

This December, Forbes magazine recognized 27 breast oncologists across the country as exemplary physicians in the field of oncology. Individuals on the list serve in the top spots of their respective hospitals, contribute a wealth of clinical research to advance the practice, and serve on community ...

Oncologists Urged to Be Proactive in Advising Patients to Reduce Risk of Alcohol-Related Cancers

A recently released ASCO statement summarizing extensive evidence linking alcohol use to an increased risk of several leading cancers, including breast, colon, and head and neck, called on oncologists “as front-line providers for cancer patients” to help patients reduce excessive alcohol use.1...

Giving Back After Cancer

My diagnosis of neuroblastoma when I was 14 happened rather accidentally. I was a competitive dancer and very active in sports my first year in high school and had no symptoms of cancer or any illness. It wasn’t until my mother, who is a nurse, came into my room one morning to wake me for school...

FDA Grants Accelerated Approval to Bosutinib for Treatment of Newly Diagnosed Philadelphia Chromosome–Positive CML

On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bosutinib (Bosulif) for treatment of patients with newly diagnosed chronic-phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML). Approval was based on data from an open-label,...

American Association for the Advancement of Science Inducts New Fellows

The American Association for the Advancement of Science (AAAS) has recently inducted 396 members as fellows, with 21 members having oncology backgrounds. Members have been awarded this honor because of their scientifically or socially distinguished efforts to advance science or its applications....

FCC, NCI Working to Improve Rural Cancer Care via Broadband Access

The Connect2Health Task Force, an initiative of the Federal Communmications Commission (FCC), has announced that the FCC and the National Cancer Institute (NCI) have joined forces, signing a memorandum of understanding that will focus on how increasing broadband access and adoption in rural areas...

The Puzzle Table

The ASCO Post is pleased to reproduce installments of the “Art of Oncology” as published previously in the Journal of Clinical Oncology. These articles focus on the experience of suffering from cancer or of caring for people diagnosed with cancer, and they include narratives, topical essays,...

Seven Leaders Join MD Anderson Cancer Center Board of Visitors

The University of Texas MD Anderson Cancer Center Board of Visitors welcomed seven new members at its annual meeting in early November: Randy A. Foutch, Winell Herron, Cyvia Wolff, Isabella Arjona-Zappala, R. Stan Marek, Jr, Walker N. Moody, and Jerry Simon. The Board of Visitors is a...

solid tumors
breast cancer

Neratinib Is Approved: Should We Reject It Anyway?

The U.S. Food and Drug Administration (FDA) approved 1 year of extended adjuvant neratinib (Nerlynx) after chemotherapy and a year of trastuzumab (Herceptin) for HER2-positive breast cancer this summer on the basis of the ExteNET trial. Many were surprised at the approval, since the evidence of...

Mount Sinai Surgeons Remove Cancerous Lymph Nodes Using Novel Robot-Assisted Procedure

A team of surgeons at Mount Sinai Beth Israel, led by Hyunsuk Suh, MD, Assistant Professor in the Department of Surgery at the Icahn School of Medicine at Mount Sinai, has performed the first robot-assisted radical neck dissection in the United States using the bilateral axillo-breast approach, a...

FDA Grants Regular Approval to Pertuzumab for Adjuvant Treatment of HER2-Positive Breast Cancer

On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. Approval was...

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