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Latest Stories
Regulatory News
The FDA Oncologic Drugs Advisory Committee July 25 voted unanimously to set more rigorous standards for new trials for approval of perioperative indications of cancer drugs.
White House
What will happen to biomedical research and health care in the aftermath of the 2024 election? The differences in outcomes couldn’t be more stark.
Letter To The Editor
In the July 19 article “Platinum drugs are off the shortage list, but the underlying problem is unsolved,” FDA Commissioner Robert Califf and others describe a solution to the U.S. drug shortage as a matter of paying more for generic drugs.
Trials & Tribulations
Cancer treatment is steadily improving. The proof can be found in the number of patients with cancer living longer than ever before. Over the next decade, the number of people who have lived five or more years after their diagnosis is projected to increase approximately 30% to 16.3 million.
In the Archives
Tobacco companies have capitalized on the Olympics’ widespread cultural impact since the birth of the modern Olympic Games in 1896—until the practice was stopped in 1987.
In Brief
Jonathan M. Gerber was named chief clinical officer of NYU Langone Health’s Perlmutter Cancer Center.
In Brief
Erika Newman was named associate director for cancer health equity, and Simpa Salami was named associate director for research workforce and leadership development at Rogel Cancer Center.
In Brief
Sanjay S. Reddy, an associate professor in the Department of Surgery, program director of the Complex General Surgical Oncology Fellowship, and co-director of the Marvin & Concetta Greenberg Pancreatic Cancer Institute, was promoted to division chief of surgical oncology at Fox Chase Cancer Center.
In Brief
Michelle Pedersen joined Fox Chase Cancer Center as a hospitalist and assistant professor in the Division of Hospital Medicine within the Department of Medicine.
In Brief
Kristi Hendriks has been elected to the Lymphoma Research Foundation’s board of directors. Hendriks is an entrepreneur, philanthropist, and wife of Boston Red Sox player and cancer survivor Liam Hendriks.
In Brief
Investigators from the UCLA Health Jonsson Comprehensive Cancer Center were awarded a $4 million grant from NCI to help advance immune-based therapies to improve treatments and outcomes for people diagnosed with pancreatic ductal adenocarcinoma.
In Brief
The Davidoff Comprehensive Cancer Center, Israel’s only cancer hospital, opened an Adolescent & Young Adult Cancer Clinic to help patients going through treatment between the ages of 18-44.
Clinical Roundup
Bintrafusp alfa, a novel bispecific antibody, achieved an objective response rate of 22% in women with recurrent or metastatic cervical cancer in a phase II nonrandomized controlled trial.
Clinical Roundup
Socioeconomic factors can influence the diagnosis and treatment of children in Texas with malignant solid tumors, increasing the risk of the cancer’s spread and lowering the five-year survival rate, according to researchers at UT Southwestern Medical Center.
Clinical Roundup
Scientists have identified a potential driver of aggressive lung cancer tumors in patients who live in areas with high levels of violent crime. Their study found that stress responses differ between those living in neighborhoods with higher and lower levels of violent crime, and between cancerous and healthy tissues in the same individuals.
Clinical Roundup
DNA/RNA material contained in circulating extracellular vesicles secreted into the bloodstream by tumor cells captures cancer genomics and transcriptomic evolution in patients with metastatic prostate cancer, according to a new study.
Clinical Roundup
A new study details the critical influence of CD5, a key immunomodulatory protein, on engineered T-cell therapies, which is the foundational basis of the clinical-stage cell therapy company Vittoria Biotherapeutics’ proprietary Senza5TM platform.
Clinical Roundup
Avenda Health, an AI healthcare company, announced the Centers for Medicare & Medicaid Services has assigned a national payment rate for the company’s innovative prostate cancer mapping technology, Unfold AI.
Clinical Roundup
To help accelerate research into new treatments for acute myeloid leukemia and myelodysplastic syndrome, Thermo Fisher Scientific Inc. is partnering with NCI on the myeloMATCH (Molecular Analysis for Therapy Choice) precision medicine umbrella trial.
Drugs & Targets
FDA has accepted the filing of Telix Pharmaceuticals Limited’s New Drug Application for TLX007-CDx, a new and proprietary cold kit for the preparation of PSMA-PET imaging for prostate cancer.
Drugs & Targets
FDA cleared the investigational new drug application for ZW191, a novel folate receptor-α targeted topoisomerase I inhibitor antibody-drug conjugate sponsored by Zymeworks.
Drugs & Targets
The European Medicines Agency validated Bristol Myers Squibb’s Type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a potential first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma who have not received prior systemic therapy.
Drugs & Targets
The European Medicines Agency has accepted the marketing authorization application for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex) as a treatment for relapsed or refractory multiple myeloma.
More than a year after a catastrophic shortage of platinum-based chemotherapy drugs swept through the U.S., FDA on June 28 officially removed carboplatin and cisplatin from the drug shortage list.
Free
When air sirens sound over Kyiv, Ukraine, patients undergoing bone marrow transplants at Ohmatdyt National Children’s Hospital don’t have the option of going to the bomb shelter.
In a change in methodology, U.S. News & World Report has integrated Medicare Advantage data into the analyses for patient outcomes, creating a shift in rankings for specialties that include oncology.
White House
Source: Livestream of White House Africa Cancer Care ForumThe White House Cancer Moonshot is committing an additional $100 million to programs focused on reducing cancer burden in African countries.
Health Equity
The Centers for Medicare and Medicaid Services said it intends to start providing additional reimbursement for some high-cost drugs for people with Medicare who receive care at Indian Health Service or tribal hospitals, beginning Jan. 1, 2025.
In Brief
Robert C. Gallo joined Tampa General Hospital on July 8 as founder and director of the Microbial Oncology Program at the TGH Cancer Institute and senior scientific advisor to the executive director of the TGH Cancer Institute.
In Brief
Jennifer Munson has been named director of the Fralin Biomedical Research Institute at VTC’s Cancer Research Center in Roanoke, VA.
In Brief
Monica BertagnolliBrett GuthrieNIH Director Monica Bertagnolli and Rep. for Kentucky’s 2nd congressional district, Brett Guthrie were named recipients of Friends of Cancer Research 2024 Cancer Leadership Award.
In Brief
The members of the American Society for Radiation Oncology recently elected five new officers to ASTRO’s board of directors.
In Brief
Thyme Care announced the close of a $95 million capital raise. With $55 million in equity funding, Thyme Care welcomes new investor Concord Health Partners with participation from all existing investors, including CVS Health Ventures, Town Hall Ventures, a16z Bio + Health, AlleyCorp, Echo Health Ventures, Frist Cressey Ventures, and Foresite Capital.
Clinical Roundup
The phase III ARANOTE trial, investigating Nubeqa (darolutamide) plus androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancer, has met its primary endpoint of radiological progression-free survival. Nubeqa plus ADT demonstrated a statistically significant and clinically meaningful increase in rPFS compared to placebo plus ADT.
Clinical Roundup
A Hologic-commissioned survey from Gallup reveals that while most women across the United States understand the significance of regular health screenings, an estimated 72 million have missed or postponed a recommended screening.
Clinical Roundup
Those living in disadvantaged neighborhoods have significantly higher activity of stress-related genes, research suggests, which could contribute to higher rates of aggressive prostate cancer in African American men.
Clinical Roundup
The socioeconomic status of cell donors affects the health outcomes of blood cancer patients who underwent hematopoietic cell transplantation, according to a new study led by researchers at the University of Minnesota Medical School.
Clinical Roundup
Current screening protocols fail to catch a notable number of people carrying genetic mutations associated with hereditary breast and ovarian cancer syndrome and Lynch syndrome, which increase the risk of developing certain cancers. This issue is particularly pronounced among underrepresented minorities.
Clinical Roundup
Unfold AI is better at identifying cancer margins in the prostate than physicians identifying margins by sight, according to a new study. This AI improves accuracy from 67% to 84%, giving physicians more clarity and treatment planning, allowing them to better recommend therapies tailored to each patient.
Clinical Roundup
University of Pittsburgh and UPMC Hillman Cancer Center researchers have developed a novel prompt, or ‘nudge,’ embedded in the electronic health record that flags, for treating surgeons, older patients with early-stage breast cancer who may be at risk for unnecessary lymph node surgery.
Clinical Roundup
A team led by UT Southwestern Medical Center researchers has discovered a new way that cells regulate senescence, an irreversible end to cell division.
Clinical Roundup
Cancer cells salvage purine nucleotides to fuel tumor growth, including purines in foods we eat, an important discovery with implications for cancer therapies from research by Children’s Medical Center Research Institute at UT Southwestern published in Cell.
Clinical Roundup
Researchers at Baylor College of Medicine, Texas Children’s Hospital, the University of Manitoba, and collaborating institutions revealed an unexpected way in which the protein OTX2 drives the progression of medulloblastoma—the most common aggressive childhood brain cancer.
Conversation with The Cancer Letter
More than half of deaths that are not attributed to disease progression or recurrence after CAR T-cell therapy are caused by infections—an unprecedented finding that experts say marks a shift from a conventional focus on mitigating treatment-specific adverse events to including prevention and management of infections.
Cancer History Project
Christy Erickson was seven years old when her mom lost a three-year battle with breast cancer.
In the Archives
Two decades after uncovering the role of EGFR mutations in lung cancer, scientists are still grappling with lingering research questions.
In Brief
Lei Zheng was named executive director of the Mays Cancer Center, home to UT Health San Antonio MD Anderson Cancer Center, and vice president for oncology for the University of Texas Health Science Center at San Antonio.
In Brief
Mark Burkard was named director of University of Iowa Health Care Holden Comprehensive Cancer Center.
In Brief
Glen Barber was named director of the Center for Innate Immunity and Inflammation within the Pelotonia Institute for Immuno-Oncology at the Ohio State University Comprehensive Cancer Center—James Cancer Hospital and Solove Research Institute.
In Brief
Tiffany Seagroves joined the Tulane Cancer Center and Tulane University School of Medicine as a professor in the John W. Deming Department of Medicine, Section of Hematology and Medical Oncology.
In Brief
Linda Liau, chair of neurosurgery at the David Geffen School of Medicine at UCLA, was elected as an Academician of Academia Sinica by the 35th Convocation of Academicians, the preeminent academic institution in Taiwan.
In Brief
Investigators at the UCLA Health Jonsson Comprehensive Cancer Center have received a $1.8 million grant from NCI to advance their work in personalizing cancer treatment.
In Brief
Sanaz Memarzadeh of UCLA has received two grants totaling $4.1 million to develop advanced cell-based immune therapies for high-grade serous ovarian cancers that have become resistant to conventional treatments.
In Brief
The University of Arkansas for Medical Sciences has been awarded a $1.3 million grant from NIH for its Arkansas Technology and Data Science in Health and Medicine program.
In Brief
Stephan Braun was named chief medical officer of ImCheck Therapeutics.
Clinical Roundup
A multidisciplinary team of doctors at Mayo Clinic in Arizona performed the third known total larynx transplant in the U.S.
Clinical Roundup
Genentech, a member of the Roche Group, announced that the phase II/III SKYSCRAPER-06 study evaluating tiragolumab plus Tecentriq (atezolizumab) and chemotherapy versus pembrolizumab and chemotherapy as an initial treatment for people with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer, did not meet its primary endpoints of progression-free survival at its primary analysis with a hazard ratio of 1.27 [95% CI: 1.02,1.57] and overall survival at its first interim analysis with a HR of 1.33 [95% CI: 1.02, 1.73], which was immature.
Clinical Roundup
Chemotherapy is known to cause behavioral side effects, including cognitive decline. Notably, the gut microbiome communicates with the brain to affect behavior, including cognition.
Clinical Roundup
With the number of adult cancer survivors in the United States expected to reach 23 million by 2032, the long-term needs of this population are growing yet often poorly understood and addressed.
Clinical Roundup
Using genetic engineering techniques, investigators at the Johns Hopkins Kimmel Cancer Center and its Ludwig Center, the Lustgarten Laboratory and Bloomberg~Kimmel Institute for Cancer Immunotherapy have designed a novel type of cell to recognize and fight cancer.
Clinical Roundup
Exscientia plc announced it will be expanding its work with Amazon Web Services to use the cloud provider’s artificial intelligence and machine learning services to power its platform for end-to-end drug discovery and automation.
Drugs & Targets
FDA granted Fast Track designation for 225Ac-FL-020, a radiopharmaceutical which targets prostate-specific membrane antigen for the treatment of metastatic castration-resistant prostate cancer.
Drugs & Targets
Boehringer Ingelheim and OSE Immunotherapeutics SA, a clinical-stage biotech company, announced that Boehringer will be progressing their first-in-class SIRPα immuno-oncology program into the next phase in clinical development.
Drugs & Targets
The Wistar Institute is collaborating with Accelerated Biosciences Corp. to create a platform based on human trophoblast stem cells to explore new immunotherapies that use Accelerated Bio’s proprietary technology. This collaboration could generate various types of immune cells from hTSCs, changing the field of allogeneic immunotherapies.
News Analysis
The Supreme Court last week upended one of the underpinnings of administrative law by weakening the authority of federal health agencies to rely on technical expertise as they regulate medical products, issue coverage decisions, and respond to public health crises.
Conversation with The Cancer Letter
The Supreme Court struck down the Chevron doctrine, removing one of the foundational principles of administrative law and upending the way federal agencies rely on technical subject-matter expertise. What comes next?
Satire
Sometimes profoundly important public health opportunities are discovered by accident.
Guest Editorial
Twenty years ago, the discovery of epidermal growth factor receptor mutations as drivers of tumorigenesis and viable targets for therapeutic intervention marked the beginning of a new era in lung cancer diagnosis and treatment. Since then, the field has made remarkable progress towards developing more effective targeted treatments and immunotherapies that have significantly improved patient outcomes and survival.
In the Archives
In 1998, lung cancer was the leading cause of cancer deaths in the United States, with 160,000 deaths per year. That statistic inspired Matthew Meyerson, who would soon start working at the Dana-Farber Cancer Institute, to specialize in lung cancer.
In Brief
Elizabeth Comen, a breast cancer oncologist and women’s health specialist known for her contributions in the field, has joined the Breast Cancer Center at NYU Langone Health’s Perlmutter Cancer Center as an associate professor of medicine.
In Brief
Sarah Bigelow was named executive director of the Clinical Trials Office at the Tulane Cancer Center.
In Brief
Jozef Madzo was named director of bioinformatics at the Wistar Institute. He will lead and oversee Wistar’s bioinformatics projects and initiatives across a variety of advanced biomedical research programs.
In Brief
Sonal Paul joined the George Washington University Cancer Center and the GW Medical Faculty Associates as a hematologist-oncologist specializing in gastrointestinal cancers.
In Brief
The University of Arkansas for Medical Sciences College of Pharmacy invested Marjan Boerma, director of the UAMS College of Pharmacy Division of Radiation Health and associate director of basic science in the UAMS Winthrop P. Rockefeller Cancer Institute, in the J. Thomas May Distinguished Endowed Chair in Oncology in a June 25 ceremony.
Clinical Roundup
People with metastatic kidney cancer who orally took a live biotherapeutic product called CBM588 while in treatment with immunotherapy and enzymatic tyrosine kinase inhibitors experienced improved health outcomes, according to research from City of Hope.
Drugs & Targets
FDA grants Fast Track designation to Syncromune Inc. for drug-device combo for solid tumors in mCRPC
FDA granted Fast Track designation to Syncromune Inc., a clinical-stage biopharmaceutical company, for SYNC-T SV-102 therapy, Syncromune’s lead candidate for the treatment of patients with metastatic castrate-resistant prostate cancer.
Drugs & Targets
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the granting of conditional marketing authorization of Tepkinly (epcoritamab), a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Drugs & Targets
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory follicular lymphoma or R/R diffuse large B-cell lymphoma, after two or more lines of systemic therapy.
NCI Trials
The National Cancer Institute approved the following clinical research studies last month.
Kate Choi grew up hearing conversations about skin cancer. Her grandparents had it, as did her cousins.
Clinical
Cancer centers that continue to experience pandemic-induced shortages in staffing their clinical research enterprise may soon be able to rely on support from NCI’s Virtual Clinical Trials Office to open studies and accrue patients.
White House
Leaders of three health agencies presented new initiatives focused on patient-centered research, diversity in clinical trial enrollment, and innovation in clinical research.
Obituary
Edward Sondik, an electrical engineer by training, followed a career path that led him to top public health positions.He was a director of the National Center for Health Statistics at CDC, an acting director of NCI, and a deputy director of the NCI Division of Cancer Prevention and Control.
The NCI Board of Scientific Advisors approved five new concepts and 17 reissue concepts at a joint meeting of the BSA and the National Cancer Advisory Board June 11-12.
In the Archives
Edward Sondik, former director of the National Center for Health Statistics at CDC, who previously served as an acting director of NCI, and a deputy director of the NCI Division of Cancer Prevention and Control, died on June 25. He was 82.
In Brief
The University of Texas MD Anderson Cancer Center and Rice University formed the Cancer Bioengineering Collaborative to develop innovative technologies and bioengineering approaches to improve cancer research, diagnosis, and treatment.
In Brief
The Snyder estate, now being sold by ACS. Source: Google, ©2024 AirbusThe American Cancer Society is selling the 25,000 square-foot mansion that was donated to the society by former Washington Commanders owner Dan Snyder and his wife Tanya Snyder, a breast cancer survivor, in March (The Cancer Letter, March 29, 2024).
In Brief
Vivek S. Kavadi was named CEO of the American Society for Radiation Oncology. He will succeed Laura Thevenot, who has led the organization since 2002.
In Brief
Miguel Villalona Calero was named deputy director of the University of California, Irvine Chao Family Comprehensive Cancer Center and division chief for hematology/oncology. He will start on July 8.
In Brief
Zachary SteinhartMaxwell FoiseyDebolina GangulySean Yamada-HunterThe Parker Institute for Cancer Immunotherapy, a collaborative consortium of the world’s leading immuno-oncology experts, named its 2024 class of Early Career Researcher awardees.
In Brief
The Wistar Institute’s Noam Auslander, assistant professor in the Molecular and Cellular Oncogenesis Program at the Ellen and Ronald Caplan Cancer Center, was awarded a $600,000 Women Scientists Innovation Award for Cancer Research grant from the V Foundation for Cancer Research.
In Brief
Researchers at the Winthrop P. Rockefeller Cancer Institute at the University of Arkansas for Medical Sciences have been awarded five grants from NCI in 2024, totaling $4.6 million.
In Brief
Fred Hutch Cancer Center established Partners in Science 2.0 @ Fred Hutch, a summer research program that trains middle school and high school teachers in Fred Hutch labs to expand hands-on learning experiences they can take back to the classroom.
Clinical Roundup
FDA issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting diversity action plans to support certain clinical studies.
Clinical Roundup
Researchers at Baylor College of Medicine and collaborating institutions have uncovered new potential therapeutic targets for cancer and new insights into existing cancer drug targets.
Clinical Roundup
Researchers at MD Anderson Cancer Center have demonstrated that therapeutically restoring ‘youthful’ levels of a specific subunit of the telomerase enzyme can significantly reduce the signs and symptoms of aging in preclinical models.
Clinical Roundup
The Ohio State University Comprehensive Cancer Center—Arthur G. James Cancer Hospital and Richard J. Solove Research Institute researchers have found a potentially effective drug-combination approach to treating certain patients with non-small cell lung cancer.
Clinical Roundup
Both Tai Chi and cognitive behavioral therapy can reduce insomnia in breast cancer survivors but also may provide additional health benefits by reducing inflammation and bolstering anti-viral defenses, according to a study led by UCLA Health researchers. The work was published in Brain, Behavior, and Immunity.
Clinical Roundup
Starpax Biopharma Inc. announced its Starpax Cancer Treatment Platform, an innovation using living, self-propelled, non-pathogenic bacteria that carry anticancer drugs on their surface and are sensitive to magnetic fields.
