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Selinexor Receives Fast Track Designation From the FDA in Pentarefractory Multiple Myeloma

On April 10, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to the oral selective inhibitor of nuclear export (SINE) compound selinexor for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy.  The FDA’s...

Notch Signaling and Treatment With Vismodegib in Basal Cell Carcinoma

A study by Eberl et al in Cancer Cell has pinpointed a mechanism that controls how basal cell cancers respond to treatment and offers new ideas for controlling this disease. Basal cell carcinomas are incredibly common—somewhere between 1 million to 3 million diagnosed each year—and...

FDA and EMA Accept Regulatory Submissions for Dacomitinib in Metastatic NSCLC With EGFR-Activating Mutations

On April 4, Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) accepted the company’s new drug application and granted Priority Review for dacomitinib, a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for the first-line treatment of...

FDA Expands Rucaparib Approval to Include Maintenance Treatment of Recurrent Ovarian Cancer

Today, the U.S. Food and Drug Administration (FDA) approved rucaparib (Rubraca) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy. The FDA...

Phase III REACH-2 Study in Hepatocellular Carcinoma Meets Overall Survival Endpoint

Topline results from the phase III REACH-2 study of ramucirumab (Cyramza) as a single agent in the second-line treatment of patients with hepatocellular carcinoma (HCC) were recently announced. The trial met its primary endpoint of overall survival as well as the secondary endpoint of...

FDA Grants Fast Track Designation for TAR-200 in Muscle-Invasive Bladder Cancer

On April 3, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for TAR-200, a gemcitabine-releasing intravesical system (GemRIS), for the treatment of patients with organ-confined or locally advanced muscle-invasive bladder cancer who are unfit for curative-intent therapy....

Conquer Cancer Foundation Sparks Global Oncology Innovation and Partnerships With IIG and IDEA Awards

ASCO’s Conquer Cancer Foundation has announced the recipients of its 2018 International Innovation Grants (IIG) and International Development and Education Awards (IDEA). Both the grant and award support oncology professionals in low-and middle-income countries, investing in either an innovative...

AACR Launches Initiative to Address Cancer Health Disparities in African Americans

THE AMERICAN ASSOCIATION for Cancer Research (AACR) announced the launch of a collaborative initiative known as “2020 by 2020.” The initiative will perform genomic sequencing of both malignant and benign tumor tissues from 2,020 consented African American cancer patients in addition to aggregating...

issues in oncology

How to Respond to a Patient’s Discriminatory Request for a Different Clinician

Some patients may make discriminatory requests for a different clinician for their health care.1-5 These individuals may want to avoid treatment with clinicians of a certain race, religion, gender, sexual orientation, or national origin. Oncologists are not exempt from this type of patient...

lymphoma

Is CAR T-Cell Therapy Setting a New Standard of Care in Lymphoma?

Data presented at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition on the longer-term follow-up analysis of results from the ZUMA-1 trial investigating the effectiveness of axicabtagene ciloleucel (Yescarta) in patients with refractory non-Hodgkin lymphoma (NHL) showed...

Maura Dickler, MD, Appointed Vice President of Late Phase Development at Lilly Oncology

ELI LILLY AND COMPANY announced that Maura Dickler, MD, a breast cancer clinical researcher at the Breast Medicine Service at Memorial Sloan Kettering Cancer Center (MSK), will join Lilly Oncology as Vice President of Late Phase Development in early May 2018.  Dr. Dickler is currently Section Head ...

Breast Cancer Specialist Hernan Vargas, MD, Joins Virginia Cancer Specialists

VIRGINIA CANCER SPECIALISTS, an affiliate of The US Oncology Network, has announced Hernan Vargas, MD, has joined its practice. Virginia Cancer Specialists is a cancer care and research center in Northern Virginia with more than 40 years of service to patients.  Dr. Vargas joins Virginia Cancer...

Frederick M. Schnell, MD, FACP, Named Medical Director of Community Oncology Alliance

THE COMMUNITY ONCOLOGY ALLIANCE announced that Frederick M. Schnell, MD, FACP, has been appointed to the newly created staff position of Medical Director.  Dr. Schnell has been a practicing community oncologist for 34 years and most recently Chief Executive Officer at Central Georgia Cancer Care...

2018 Gastrointestinal Cancers Symposium

The 2018 Gastrointestinal Cancers Symposium is supported by ASCO, the American Society of Radiation Oncology, the Society of Surgical Oncology, and the AGA Institute.  Over 3,700 physicians, researchers, and allied health-care professionals attended the meeting. Photos by © ASCO/Todd Buchanan ...

lymphoma

FDA Expands Approval of Brentuximab Vedotin in Classical Hodgkin Lymphoma

ON MARCH 20, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (Adcetris), an antibody-drug conjugate, to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in combination with chemotherapy. Brentuximab vedotin combines an antibody and...

supportive care

Greater Understanding of Family Dynamics May Help Cancer Teams Guide, Support Patients

WHETHER THEY are parents themselves or dealing with their own parents, patients with cancer often look to their health-care team to help guide these relationships, but data on how best to help are lacking, according to two poster presentations at the 2018 American Psychosocial Oncology Society...

EMA to Review Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma

On April 3, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery....

FDA Accepts BLA for Moxetumomab Pasudotox in Hairy Cell Leukemia

On April 3, the U.S. Food and Drug Administration (FDA) accepted a Biologics License Application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukemia (HCL) who have received at ...

Samuel Waxman Cancer Research Foundation Awards Research Grant to Craig B. Thompson, MD

THE SAMUEL WAXMAN Cancer Research Foundation (SWCRF) will present the 2018 Daid T. Workman Memorial Award to Craig B. Thompson, MD, President and Chief Executive Officer of Memorial Sloan Kettering Cancer Center, at its Breakthroughs Scientific Symposium in late April. The event brings together...

Edward M. Wolin, MD, Named Director of Center for Carcinoid and Neuroendocrine Tumors at Mount Sinai

EDWARD M. WOLIN, MD, an internationally renowned authority on neuroendocrine tumors, has joined the Mount Sinai Health System as Director of the Center for Carcinoid and Neuroendocrine Tumors. This multidisciplinary center includes specialists in gastroenterology, surgical oncology, hepatobiliary...

Destroy Pancreatic Cancer Donates $1 Million for Unique Trial

DESTROY PANCREATIC CANCER, an Atlanta-based nonprofit dedicated to finding better treatments for pancreatic cancer, is donating $1 million for a unique pancreatic cancer clinical trial designed by the nonprofit Translational Genomics Research Institute.  Daniel D. Von Hoff, MD, FACP, one of the...

bladder cancer
kidney cancer
prostate cancer

GU Symposium Focuses on Prognostic Model in Urothelial Cancer, Novel Therapies for Prostate and Kidney Cancers

THE 2018 GENITOURINARY Cancers Symposium hosted an international audience of oncologists and other stakeholders to hear about the latest advances in the field. We have included coverage of many of the top news stories from the meeting in previous issues of The ASCO Post. Here are summaries of a few ...

A Tribute to Two Amazing Scientists

Dr. Collins is Director of the National Institutes of Health. Originally posted on March 19, 2018, to the National Institutes of Health (NIH) Director’s Blog (https://directorsblog. nih.gov).  OVER THE PAST couple of weeks, we’ve lost two legendary scientists who made major contributions to our...

Comprehensive Genomic-Profiling Assay FoundationOne CDx Is Commercially Available

On March 30, Foundation Medicine announced that FoundationOne CDx, the first U.S. Food and Drug Administration (FDA)-approved comprehensive genomic-profiling assay for all solid tumors incorporating multiple companion diagnostics, is now available in the United States. FoundationOne CDx is a...

EBCC-11: Mastectomy and Axillary Dissection and Neoadjuvant Targeted Treatment in HER2-Positive Breast Cancer

Extensive surgery involving mastectomy and removal of several lymph nodes may be safely avoided for more women with some types of breast cancer if they receive targeted drugs before surgery, according to research presented at the 11th European Breast Cancer Conference (EBCC-11) (Abstract 19). The...

In Remembrance of James F. Holland, MD

The ASCO Post mourns the loss of ASCO Past President James F. Holland, MD, FASCO, on March 22, 2018. Dr. Holland was the Distinguished Professor of Neoplastic Diseases in the Department of Medicine at the Icahn School of Medicine at Mount Sinai in New York. His wife of many years, Jimmie C....

The Clinical Significance of Clinicaltrials.gov

“I think I found the trial that is going to save your life,” Stefanie Joho’s sister said after checking out the ClinicalTrials.gov website. “And sure enough, it did. That is not an exaggeration. That is exactly what happened,” Ms. Joho, a health advocate and consultant based in Philadelphia, told...

solid tumors
supportive care

Physician-Patient Partnership Is Key to Recognizing and Managing Side Effects of Immune Checkpoint Inhibitors

“Immunotherapy has a completely different side-effect profile than chemotherapy, and that has caught physicians off guard,” noted Drew Pardoll, MD, PhD, in an article published earlier this year in The Washington Post.1 Since then, efforts have moved forward on several fronts to bring physicians,...

issues in oncology
legislation

ASCO Commends Congress for NIH Funding

On March 23, 2018, ASCO President Bruce E. Johnson, MD, FASCO, issued the following statement: The American Society of Clinical Oncology (ASCO) applauds Congress for its bipartisan support of the omnibus spending bill that significantly boosts our nation’s investment in biomedical research. By...

Thomas A. Gallo, MS, MDA, Becomes ACCC President 2018–2019

Thomas A. Gallo, MS, MDA, was named 2018–2019 President of the Association of Community Cancer Centers (ACCC) during its 44th Annual Meeting and Cancer Center Business Summit on March 16, 2018, in Washington, DC. Mr. Gallo is Executive Director of the Virginia Cancer Institute in Richmond. ACCC...

NCCN® Adopts New Web-Based Software Platform for Research

The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP) announced the selection and implementation of the iEnvision medical affairs platform, developed by Envision Technology Solutions. The NCCN ORP supports research through collaborations with pharmaceutical companies...

hematologic malignancies
leukemia

FDA Expands Nilotinib Indication to Pediatric Patients With CML

On March 22, the U.S. Food and Drug Administration (FDA) expanded the indication for nilotinib (Tasigna) to include treatment of first- and second-line pediatric patients 1 year of age or older with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in the chronic phase. In the United ...

More on the ABCSG-16 Trial

Postmenopausal women with hormone receptor–positive breast cancer who took the aromatase inhibitor anastrozole for 2 years after an initial 5 years of adjuvant endocrine therapy received an equal benefit to those who took the drug for 5 additional years. The trial results suggest that a shorter...

solid tumors
breast cancer

Extended Duration of Aromatase Inhibitors Need Not Be Very Long

At the 2017 San Antonio Breast Cancer Symposium (SABCS), Michael Gnant, MD, FACS, of the Medical University of Vienna presented the 9-year median follow-up of a trial looking at the length of extended aromatase inhibitor therapy. At least four other recently presented or published trials have...

AACR Welcomes New Leadership

The members of the American Association for Cancer Research (AACR) have elected five members to serve on the AACR Board of Directors for the 2018–2021 term and four members to serve on the Nominating Committee for the 2018–2020 term. These new directors and committee members began their terms at...

James C. Wittig, MD, Joins Atlantic Health System Orthopedic Oncology Leadership Team

James C. Wittig, MD, has been appointed Chairman of the Department of Orthopedics at the Morristown Medical Center and Medical Director of Orthopedic Oncology within the Atlantic Health System. Dr. Wittig will be responsible for ensuring quality, academic excellence, and optimal operational...

Huda Zoghbi, MD, Awarded Ross Prize in Molecular Medicine

The Feinstein Institute for Medical Research at Northwell Health has selected Baylor College of Medicine’s Huda Zoghbi, MD, as the winner of the sixth annual Ross Prize in Molecular Medicine. The prize, which includes a $50,000 award, will be presented to Dr. Zoghbi in early June at the New York...

Yale Cancer Center Launches Immuno-Oncology Center

Yale Cancer Center has launched the Yale Center for Immuno-Oncology. The new center will build on Yale Cancer Center’s international leadership in immunobiology, cancer immunology, and development of novel cancer immunotherapies. It is a partnership between Yale Cancer Center and the Department of...

solid tumors
gynecologic cancers

Leading Health Organizations Issue Challenge to Defeat Cervical Cancer

The Consortium of Universities for Global Health, Perlmutter Cancer Center, and the Department of Population Health at NYU Langone Health are issuing the “New York Challenge,” an ambitious campaign to end cervical cancer worldwide. They are challenging all nations to achieve a 70% human...

hematologic malignancies
lymphoma

Solid Organ Transplantation and Lymphoma

Survival of patients with Hodgkin and non-Hodgkin lymphomas is increasing, and with that comes the need, in some cases, for solid organ transplantation, often because of treatment-related toxicity. The factors involved in organ transplant among lymphoma survivors were discussed by Philip J....

SGO 2018: Participation in Clinical Trials May Overcome Health Disparities in Ovarian Cancer

Participation in clinical trials may overcome health disparities in the treatment of advanced or recurrent ovarian cancer, according to a study presented at the Society of Gynecologic Oncology’s (SGO) 2018 Annual Meeting on Women’s Cancer (Abstract 6). The study evaluated the effect of ...

IMpower150: Increased OS With Atezolizumab/Bevacizumab Plus Chemotherapy in Advanced Nonsquamous NSCLC

The phase III IMpower150 study met its coprimary endpoint of overall survival (OS) at interim analysis and showed that first-line treatment with the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) plus carboplatin and paclitaxel (chemotherapy) helped patients with advanced...

EBCC-11: Women Report Fewer Side Effects With Partial or Reduced Breast Radiotherapy vs Standard WBRT

The average number of moderate or marked side effects reported by patients with breast cancer is lower if they are treated with radiotherapy to part of the breast or a reduced dose to the whole breast, rather than with standard whole breast radiotherapy (WBRT), according to new findings presented...

First Interim Analysis of Phase III SEQUOIA Trial in Pancreatic Cancer

ARMO BioSciences, Inc, recently announced the completion of the first interim analysis in its phase III SEQUOIA trial in patients with pancreatic cancer. The Data Monitoring Committee (DMC) for SEQUOIA, a clinical trial studying pegilodecakin (AM0010) plus FOLFOX (leucovorin,...

EBCC-11: MINDACT Trial: Patients With Early Breast Cancer and Risk of Locoregional Recurrence

Women with small, low-grade, well-defined breast tumors and a genetic profile that shows they are at low risk of the cancer metastasizing have only a 1.4% risk of locoregional recurrence within 5 years, according to new results from a large randomized trial of nearly 7,000 patients. This low risk...

AAD Issues Guidelines for Treatment of Nonmelanoma Skin Cancer

Skin cancer is the most common cancer in the United States, and nonmelanoma skin cancer is the most common type of skin cancer, affecting more than 3 million Americans every year. Moreover, nonmelanoma skin cancer incidence is growing at an exponential rate—between 1976–1984 and...

SGO 2018: Immunotherapy/PARP Inhibitor Combination Produces Remissions in Ovarian Cancer

A combination of the immunotherapy pembrolizumab (Keytruda) and the DNA repair–blocking agent niraparib (Zejula) can be significantly more effective than either drug alone in women with hard-to-treat ovarian cancer, a phase I/II clinical trial led by Dana-Farber Cancer Institute researchers...

EBCC-11: Sentinel Lymph Node Biopsy in Triple-Negative and HER2-Positive Breast Cancers

Sentinel lymph node biopsies may be safely avoided for some women, according to research presented at the 11th European Breast Cancer Conference (EBCC-11). Two new studies show that women with either triple-negative or HER2-positive types of breast cancer, whose cancers respond well to chemotherapy ...

FDA Accepts sBLA for Nivolumab Plus Ipilimumab in Previously Treated MSI-H or dMMR Metastatic Colorectal Cancer

On March 27, the U.S. Food and Drug Administration (FDA) accepted a supplemental biologics license application (sBLA) for nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of adults with microsatellite instability–high (MSI-H) or mismatch repair deficient...

FDA Expands Approval of Blinatumomab for Certain Patients With B-Cell Precursor ALL

The U.S. Food and Drug Administration granted accelerated approval to blinatumomab (Blincyto) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). In patients who have achieved remission after...

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