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The Senate Appropriations Committee voted to provide significant increases to federal health agencies in fiscal year 2025, including raises of nearly $2 billion for NIH and $270 million for NCI.
By Matthew Bin Han Ong
Health Equity
By the end of 2022, Toni Monteiro had no fight left in her. She had been battling a rare blood cancer for three years. Her husband had just died. She was at risk of being evicted from her Washington, DC, apartment. Also, her heart was failing. “You’re really under stress,” Monteiro recalls her physician saying. ...
By Matthew Bin Han Ong
Conversation with The Cancer Letter
Allison Dowling knew a career in medicine wasn’t for her. She’d seen firsthand the pain and stress experienced by patients who didn’t have the wherewithal to navigate systemic barriers in health care—problems that often fall outside the jurisdiction of the clinic.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
In her final year as a medical student, Francisca Finkel chose an elective rotation that is offered by few med schools: Working with lawyers to resolve non-medical issues that harm patients with cancer.
By Matthew Bin Han Ong
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.
By Matthew Bin Han Ong
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.
By Matthew Bin Han Ong
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.
By Matthew Bin Han Ong
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?
By Matthew Bin Han Ong
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.
By Matthew Bin Han Ong
Capitol Hill
Two Republican leaders in the House of Representatives have published a “framework” for reforming NIH—consolidating the agency’s 27 institutes and centers into 15—arguing that a fundamental rethinking of NIH’s structure would fix what they describe as a “system rife with stagnant leadership, as well as research duplication, gaps, and misconduct.”
By Matthew Bin Han Ong
NCI Director's Report
After a year of lean appropriations, NCI is looking at what threatens to be a budgetary cataclysm—a potential 10-11% cut to the Labor-HHS spending bill in fiscal year 2025.
By Matthew Bin Han Ong
Directors of NCI-designated cancer centers are facing a new set of challenges in a polarizing, high-stakes election year.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
Christopher Li, the Helen G. Edson Endowed Chair for Breast Cancer Research at Fred Hutchinson Cancer Center, understands what it means to be an underrepresented minority at each stage of his academic career.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
All women should start screening for breast cancer at age 40, with biennial screening continuing through age 74, the U.S. Preventive Services Task Force said in its final recommendation statement April 30.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
Can AI-enabled technology safeguard hospitals, pharmacies, and medical devices from cyberattacks?
By Matthew Bin Han Ong
NCI Director's Report
With NCI funding expected to remain flat through fiscal year 2025, health professionals and leaders in oncology should use this time to amp up institutional efforts to collaborate and rebuild trust in science, NCI Director Kimryn Rathmell said.
By Matthew Bin Han Ong
Health Equity
To address inequities in cancer health, NCI is collaborating with a diverse team of experts and cancer center directors—named the Cancer Equity Leaders (CEL)—to learn from communities and inform workforce development as well as outreach initiatives.
By Matthew Bin Han Ong
NCI is lowering paylines for R01 grants for established and new investigators to the 10th percentile, down from the 12th percentile in FY23.
By Matthew Bin Han Ong
Capitol Hill
Credit: National Cancer Institute, National Institutes of HealthHalfway into fiscal year 2024, NCI officials are crunching numbers, trying to find ways to live with an appropriation that, for the first time since sequestration, reduces the institute’s spending power.
By Matthew Bin Han Ong
NCI Director's Report
Addressing the NCI Board of Scientific Advisors, Institute Director Kimryn Rathmell announced two key initiatives—the Cancer Screening Research Network and the Virtual Clinical Trials Office—designed to achieve large reductions in cancer mortality and support the cancer research enterprise.
By Matthew Bin Han Ong
U.S. Deputy Secretary for Health and Human Services, Andrea Palm, and Sweden's Minister for Health Care, Acko Ankarberg Johansson, signing the agreement. Credit: Joel Apelthun/Government Offices of SwedenThe United States and Sweden signed an agreement to step up collaborations in science and technology by focusing on cancer research.
By Matthew Bin Han Ong
Regulatory News
When conducting a randomized clinical trial of a treatment regimen based on an immune checkpoint inhibitor, trial sponsors should include overall survival as an endpoint, FDA officials say.
By Matthew Bin Han Ong and Paul Goldberg
White House
Source: White HouseIn a fiery State of the Union speech designed to showcase his performance as a veteran politician, President Joe Biden leaned into his accomplishments in health care.
By Matthew Bin Han Ong
Clinical
Developers of an investigational multi-target screening test for colorectal cancer and its precursors are aiming to replace the widely used conventional fecal immunochemical test.
By Matthew Bin Han Ong
Clinical
In a major breakthrough in cellular therapy, FDA has approved the first tumor-infiltrating lymphocyte therapy for patients with unresectable or metastatic melanoma who have received prior treatment, including with checkpoint inhibitors.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
Feb. 16, 2024, is a landmark date in the history of immuno-oncology.
By Matthew Bin Han Ong
Capitol Hill
The House Committee on Energy and Commerce has issued a subpoena to require NIH Director Monica Bertagnolli to provide information related to NIH’s handling of allegations of sexual harassment and workplace misconduct.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
Shikha Jain, Shea Holman: It’s time for NIH to be transparent about how misconduct cases are handled
NIH has until Feb. 20 to comply with a congressional subpoena that directs NIH Director Monica Bertagnolli to produce internal documents, including reports and whistleblower complaints that could shed light on whether NIH is adequately responding to complaints of workplace misconduct and sexual harassment.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
As artificial intelligence becomes an indispensable tool in cancer research, drug sponsors and researchers should focus on building and utilizing rich real-world evidence databases that can be used to complement clinical trials.
By Paul Goldberg and Matthew Bin Han Ong
Real-world Evidence
Two major cancer informatics companies—Flatiron Health and Caris Life Sciences—have created a partnership to generate combined biological and clinical real-world evidence datasets that can be used to inform the development of immuno-oncology agents and targeted cancer therapeutics.
By Matthew Bin Han Ong
Clinical
To improve evidence generation in studies designed to bring therapeutic agents to market, FDA is urging drug sponsors not to skip dose optimization at the outset of clinical development. The agency is also telling industry that it’s open to accepting trials that have pragmatic elements and are augmented by data generated in academia.
By Matthew Bin Han Ong
NIH and FDA envision transforming the way clinical trials are done across the biomedical research enterprise.
By Matthew Bin Han Ong
NCI Director's Report
The gridlock in Washington is taking a toll on federally funded cancer research as the partisan wrangling in Congress over border security and funding for Israel and Ukraine shows no sign of relenting.
By Matthew Bin Han Ong
White House
Invoking the Defense Production Act, President Joe Biden has ordered federal agencies and artificial intelligence companies to create safeguards and standards for the technology that has the capacity to uplift humankind as much as it can wreak unimaginable harm.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
As a data scientist and software engineer, Razik Yousfi builds artificial intelligence models in health care. He started doing this 15 years ago, long before advanced chatbots catapulted AI into the layman’s consciousness.
By Matthew Bin Han Ong
Capitol Hill
Monica M. Bertagnolli, the 16th NCI director, has been confirmed as the 17th director of NIH—six months after the White House first named her to lead the world’s largest public funder of biomedical research.
By Matthew Bin Han Ong
Health Equity
The ECOG-ACRIN Cancer Research Group has renamed its Group Meeting Attendance Awards for Minority Trainees to the Edith Peterson Mitchell, MD Health Equity Travel Scholarships.
By Matthew Bin Han Ong
The Advanced Research Projects Agency for Health is setting up a network of partners that would enable the federal government to fund and roll out new initiatives nationwide.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
A year ago, Renee Wegrzyn signed up for a very cool job. As the inaugural director of the Advanced Research Projects Agency for Health, she was to prove that the nontraditional, $2.5 billion experiment will yield the kind of high impact its high-risk investment model promises. Since Wegrzyn joined the agency in October 2022, ARPA-H has...
By Matthew Bin Han Ong
Capitol Hill
A House oversight committee said it intends to exercise the power of subpoena to compel the NIH Office of the Director to turn over documents related to allegations of sexual harassment and workplace misconduct.
By Matthew Bin Han Ong
Health Equity
At a time of intensifying national polarization over critical race theory and affirmative action, leaders of cancer centers are faced with two challenges that appear to be diametrically at odds with each other
By Matthew Bin Han Ong
Real-world Evidence
A novel study led by Friends of Cancer Research is providing evidence that tumor response rates can be assessed across real-world data sets, bringing regulators one step closer to potentially building a framework for pre-market evaluation of cancer drugs and post-market tracking of drug performance based on real-world endpoints.
By Matthew Bin Han Ong
Capitol Hill
Nearly 80% of NIH staff will be furloughed if Congress fails to fund the federal government or pass a continuing resolution before midnight Saturday, Sept. 30—halting many administrative functions and nonclinical activities in the agency’s research pipelines.
By Matthew Bin Han Ong
Capitol Hill
With just days left before the end of September, and with it, the end of fiscal year 2023, NCI officials are preparing for rough times, both in the short term and long term.
By Matthew Bin Han Ong
White House
The Advanced Research Projects Agency for Health will issue $240 million in cancer-related awards over the next few weeks, the White House announced at a Cancer Cabinet meeting Sept. 13.
By Matthew Bin Han Ong
Capitol Hill
A confirmation hearing for NCI Director Monica Bertagnolli will take place sometime in October, said Sen. Bernie Sanders (I-VT), chairman of the Senate Health, Education, Labor, and Pensions Committee.
By Matthew Bin Han Ong
The world’s only biobank that collects healthy breast tissue is once again taking the lead to fulfill another unmet need in breast cancer research: collecting tissue from men to understand how male breast cancer develops.
By Matthew Bin Han Ong
White House
The first 10 drugs selected for price negotiations under Medicare Part D program includes only one oncology drug: ibrutinib (Imbruvica), a tyrosine kinase inhibitor indicated for the treatment of blood cancers, including chronic lymphocytic leukemia and small lymphocytic lymphoma.
By Matthew Bin Han Ong
NCI Director's Report
The Office of the Secretary of Health and Human Services is coordinating a health informatics initiative—as part of the Cancer Moonshot—to set common data standards that could be used across key federal health agencies, including NCI, NIH, and FDA.
By Matthew Bin Han Ong
At a glance, the 2023-24 U.S. News & World Report ranking for Best Hospitals for Cancer looks the way it always has—a list of premier institutions. You have to dig deeper to find changes in the way the closely watched 40-year-old ranking was put together and why these changes in methodology were made.
By Matthew Bin Han Ong
NCI Director's Report
NCI continues to face the prospect of flat funding in fiscal year 2024 as a spending bill proposes a 3% cut to NCI’s budget, which threatens to further reduce the institute’s purchasing power, said NCI Director Monica Bertagnolli.
By Matthew Bin Han Ong
In an era of intensifying judicial repudiation of evidence-based guidelines and deepening public mistrust toward science, America’s screening rate for cervical cancer has been declining.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
St. Jude’s Path to a Bright Future, an HPV awareness and vaccination campaign with nearly 160 partners, is aimed at reducing that disease burden by targeting children in a crucial age range.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
The standard of care in HPV vaccination may soon change if a one-dose regimen is found to be just as efficacious as two or three doses—once a large trial that NCI is conducting in Costa Rica, in young women ages 12 to 16, is ready to report final results in a few years. “We’ve done...
By Matthew Bin Han Ong
Clinical
Circulating tumor DNA has the potential to not only change the way medical oncologists assess and treat cancer patients, but also how cancer drugs are reviewed, oncology experts at FDA and pharmaceutical companies said in response to research findings published July 11 by a collaboration led by Friends of Cancer Research.
By Matthew Bin Han Ong
Clinical
As researchers consider using circulating tumor DNA as an endpoint in clinical trials to evaluate drug efficacy, a collaboration led by Friends of Cancer Research is creating the evidentiary roadmap for the use of ctDNA in regulatory decisions.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
On June 29, the United States Supreme Court issued a ruling that reverses 45 years of legal precedent in admissions at institutions of higher learning, striking a death blow to affirmative action.
By Paul Goldberg and Matthew Bin Han Ong
Free
After taking eight months to respond to a House committee’s questions about policies on handling of sexual misconduct cases, a letter from NIH has provided answers that critics describe as vague and inadequate.
By Matthew Bin Han Ong
Moving away from recommendations dating back to 2009, the U.S. Preventive Services Task Force now states that women should start biennial screening for breast cancer at age 40—instead of 50—a change that experts say is based on new, inclusive science.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
The U.S. Preventive Services Task Force’s latest draft recommendation on breast cancer screening is based in part on data on racial disparities in breast cancer mortality.
By Matthew Bin Han Ong
Regulatory News
Can data from one CAR T-cell therapy be used to inform FDA’s review of other CAR T products?
By Matthew Bin Han Ong
In a city that in recent years has come to epitomize the growing racial divide in wealth and health outcomes, Georgetown University’s Lombardi Comprehensive Cancer Center, with help from the Ralph Lauren Corporate Foundation, is establishing a patient navigation, screening, and education center to serve historically marginalized neighborhoods.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
On April 17, Louis Weiner found himself wishing he could be in two places at once—dance at two weddings, as it were.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
Ralph Lauren wasn’t interested in an eponymous cancer center when, in 2003, he helped establish the first Ralph Lauren Center in Harlem.
By Matthew Bin Han Ong
Free
This point is easily overlooked: Monica Bertagnolli has two jobs, not one. She is the director of the National Cancer Institute and head of the National Cancer Program.
By Paul Goldberg and Matthew Bin Han Ong
Judiciary
The United States has the worst health outcomes of any high-income nation—lagging behind on health status indicators including mortality, fertility, and morbidity—and recent rulings by Texas district judges against preventive services and mifepristone would widen that gap, experts say.
By Matthew Bin Han Ong
NCI Director's Report
NCI has released the language of the much-discussed National Cancer Plan, an eight-goal blueprint that spans the spectrum of cancer care—prevention, treatment, and survivorship—to correspond with President Joe Biden’s vision of cutting cancer mortality by half in 25 years.
By Matthew Bin Han Ong
Federal agencies can no longer enforce a critical provision in the Affordable Care Act that requires insurance plans to fully pay for preventive services that receive an “A” or “B” grade from the U.S. Preventive Services Task Force—including many new and updated recommendations on screening for cancer and other diseases.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
In an era of judicial conservatism, a recent ruling that invalidates the Affordable Care Act’s preventive services mandate is likely to be upheld by higher courts, including the Supreme Court, legal experts say.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
NYU’s Art Caplan: Texas ruling that nixes USPSTF authority embodies “bigotry, hatred, and ignorance”
A ruling by a Texas District Court judge that invalidates the Affordable Care Act’s preventive services mandate is based in part on claims that availability of pre-exposure prophylaxis pills would "encourage homosexual behavior and intravenous drug use.”
By Matthew Bin Han Ong
NCI Director's Report
NCI is on the cusp of releasing designs for its National Cancer Plan, an initiative that would guide the institute’s mission and portfolio for years to come and engage everyone in oncology to “end cancer as we know it,” said NCI Director Monica Bertagnolli.
By Matthew Bin Han Ong
After the stunning success of mRNA vaccines during the COVID-19 pandemic, researchers and biotech companies are racing to prove the utility of the technology in an array of non-communicable diseases—including cancer, cystic fibrosis, and sickle cell disease.
By Matthew Bin Han Ong
Capitol Hill
Undeterred by NIH’s failure to address a set of questions submitted seven months ago, a House oversight committee is persisting with its investigation into handling of sexual harassment complaints at institutions that receive federal funding.
By Matthew Bin Han Ong
White House
President Joe Biden is requesting a $920 million increase to the NIH budget in fiscal year 2024, a 1.93% boost. Of that amount, $503 million, or nearly 55%, is slated for NCI, keeping funding for the majority of other NIH institutes and centers at FY23 levels.
By Matthew Bin Han Ong
Clinical
Academic cancer centers are facing severe staffing shortages after three years of personnel attrition during the COVID-19 pandemic—resulting in depressed levels of patient accrual to investigator-initiated and grant-funded clinical trials.
By Matthew Bin Han Ong
NCI Director's Report
NCI is increasing the R01 payline to the 12th percentile in fiscal year 2023, up from the 11th percentile in FY22—bringing the institute’s payline to a level not seen since 2010.
By Matthew Bin Han Ong
White House
President Joe Biden mentioned cancer 13 times in his impassioned State of the Union address and placed cancer research at the top of his Unity Agenda—an indication that his administration would continue to prioritize funding for cancer research in fiscal year 2024.
By Matthew Bin Han Ong
Free
On May 25, 2020, George Floyd said “I can’t breathe” more than 20 times before he suffocated on a street in Minneapolis. On Jan. 7, 2023, Tyre Nichols repeatedly screamed, “Mom, mom, mom” as he was beaten to death on a street in Memphis.
By Matthew Bin Han Ong
Cancer Treatment Centers of America will “fully transition” to City of Hope’s brand, giving the southern California-based cancer care health system a national footprint.
By Matthew Bin Han Ong
For a decade, thousands of PhDs in epigenetics may have been relying on the wrong tool as they study the biological processes that regulate how and when genes are expressed or silenced.
By Jacquelyn Cobb and Matthew Bin Han Ong
Conversation with The Cancer Letter
It took a team of researchers more than 18 months to get their paper on epigenetic variation published—likely because they are saying that epigeneticists have been fishing in the wrong pond for a decade.
By Jacquelyn Cobb and Matthew Bin Han Ong
Conversation with The Cancer Letter
Medicare Advantage, the private insurance alternative to traditional Medicare, is popular for several reasons: lower premiums, dental and vision coverage, and a cap on out-of-pocket costs.
By Matthew Bin Han Ong
Capitol Hill
NIH and NCI received a $2.5 billion and $408 million increase, respectively, in the fiscal year 2023 omnibus appropriations package that President Joe Biden signed into law Dec. 23.
By Matthew Bin Han Ong
Clinical
A personalized mRNA cancer vaccine sponsored by Moderna and Merck has the potential to change the standard of care for melanoma patients—and reshape the landscape of cancer vaccines—if the company’s latest data on the vaccine are validated in a phase III clinical trial.
By Matthew Bin Han Ong
Free
Monica Bertagnolli, the 16th director of the National Cancer Institute, announced that she will be undergoing treatment for early-stage breast cancer.
By Paul Goldberg and Matthew Bin Han Ong
Conversation with The Cancer Letter
The past six weeks have brought fundamental change in the way oncology drugs are being developed. At this unprecedented moment in oncopolitics, FDA, NCI, academic oncologists, advocates, and the industry are in agreement on how cancer therapies should be developed, tested and approved.
By Jacquelyn Cobb, Matthew Bin Han Ong and Paul Goldberg
Within two months of stepping in as director of the Advanced Research Projects Agency for Health, Renee Wegrzyn has grown her staff fivefold, built a website, juggled 30 congressional meetings, and met with 10 patient advocacy organizations.
By Matthew Bin Han Ong
Clinical
Pragmatica-Lung is shaping up as the clinical trial to watch—not just because of the research question, but because of the way it’s being addressed.
By Jacquelyn Cobb, Matthew Bin Han Ong and Paul Goldberg
Conversation with The Cancer Letter
The Pragmatica-Lung trial required many people to start to think differently about conducting phase III clinical trials—and it took a lot of advocacy to make the trial launch quickly, said Ellen Sigal, founder and chair of Friends of Cancer Research.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
Patients with metastatic non-small cell lung cancer who are matched to targeted therapy live longer when liquid biopsies are used to detect genomic alterations in circulating tumor DNA that aren’t picked up by tissue sequencing, according to a study published Nov. 10 in Nature Medicine.
By Matthew Bin Han Ong
White House
The American Cancer Society has formed two roundtables—focused on breast and cervical malignancies—to eliminate disparities and improve policies and care systems.
By Matthew Bin Han Ong
White House
The White House and the American Cancer Society will convene leaders in academic oncology and across public and private arenas to address challenges in breast and cervical cancers on Oct. 24 in Washington, D.C.
By Matthew Bin Han Ong
NCI Director's Report
“Yesterday, I went to sleep as acting NCI director, and this morning, as I woke up, I have a new boss, Monica Bertagnolli,” Douglas R. Lowy said in the morning of Oct. 3, addressing a well-caffeinated meeting of the Association of American Cancer Institutes.
By Matthew Bin Han Ong
Free
Oct. 3 was Monica M. Bertagnolli’s first day on the job as the 16th director of the National Cancer Institute.
By Matthew Bin Han Ong
Conversation with The Cancer Letter
Up to 15% of U.S. counties—home to about 25 million Americans—fall outside the reach of the catchment area of this country’s cancer centers.
By Matthew Bin Han Ong
NCI Director's Report
Drawing on Charles Dickens, NCI Acting Director Douglas Lowy has a teaching moment for oncology: we live in the best of times as well as the worst of times, because only fragments of human society—both in the United States and in low- and middle-income countries—fully benefit from modern cancer care.
By Matthew Bin Han Ong
White House
When you are making a point that the country that put humans on the moon also has the capacity to cure cancers, venue and timing matter. On Sept. 12, President Joe Biden chose John F. Kennedy Presidential Library and Museum—and the 60th anniversary of Kennedy’s 1962 moonshot speech—to announce his plan’s latest iteration.
By Matthew Bin Han Ong
Capitol Hill
A House committee is requesting that NIH provide answers to 30 questions about the “pervasive culture of sexual harassment” in biomedical research.
By Matthew Bin Han Ong
NCI Director's Report
As NCI prepares for a transition of leadership, Acting Director Douglas Lowy is setting out an agenda focused on multi-cancer detection tests, undruggable targets, cell therapy, and on eliminating disparities caused by persistent poverty.
By Matthew Bin Han Ong
White House
President Joe Biden has announced his intent to appoint Monica Bertagnolli as the 16th director of the National Cancer Institute—and the first woman and first chair of a clinical trials cooperative group to be named to the role.
By Matthew Bin Han Ong
