Home – Page 28 – The Cancer Letter

Issue 19 - May 10, 2019

TCL45-19 (276 downloads)

NCI approves Georgetown-Hackensack consortium
Are more long-distance relationships in the works?
NCI has funded a consortium uniting Georgetown Lombardi Cancer Center and John Theurer Cancer Center of Hackensack University Medical Center.
Conversation with The Cancer Letter
Georgetown’s Weiner and Hackensack’s Pecora tell us how they created a consortium spanning 233 miles
Georgetown’s Louis M. Weiner and Hackensack’s Andrew L. Pecora started to discuss forming a consortium in 2011, roughly at the time when it became clear that conferencing and data transfer technologies were making it possible for cancer centers located hundreds of miles apart to operate in a coordinated manner.
Real World Evidence
FDA issues draft guidance on using real world data in drugs, biologics
FDA has issued a draft guidance that describes the types of real world data and real world evidence that the agency would accept as part of regulatory submissions for drugs and biologics.
House committee advances FY2020 funding bill giving NIH a $2 billion raise
The House Committee on Appropriations May 8 approved a spending bill that gives NIH $41.1 billion, a $2 billion increase over the current level. The bill passed on a vote of 30 to 23.
In Brief
- Primo “Lucky” Lara now serves as SWOG deputy chair, Kathy Albain is vice president
- Tisch Cancer Institute and Precision Immunology Institute form Mt. Sinai Center for Computational Immunology
- Memorial Sloan Kettering introduces MSK Kids
- Ananth, Choi, Kirtane, Li receive NCCN Young Investigator Award
- UAMS’s Johann receives $1.4 million for lung cancer clinical trials
- Prostate Cancer Foundation publishes revised guidelines, new patient resources
Funding Opportunities
DoD Prostate Cancer Research Program– opportunities for FY19
The FY19 Defense Appropriation provides $100 million to the Department of Defense Prostate Cancer Research Program to support innovative, high-impact prostate cancer research.
Trials & Tribulations
Estimating overdiagnosis is hard—we need all the help we can get
Over the past decade there has been much consternation about overdiagnosis, the detection of cancers that would not have been diagnosed without screening.
Clinical Roundup
- BMS phase III study didn’t meet primary endpoint of OS with Opdivo + radiation in glioblastoma multiforme
- City of Hope opens multiple myeloma autologous CAR T-cell therapy trial targeting CS1 protein
Drugs & Targets
- FDA approves Kadcyla for breast cancer
- FDA grants Breakthrough Device designation to Natera’s Signatera test
- Caris Life Sciences receives FDA Breakthrough Device designation for MI Transcriptome companion diagnostic test
- European Commission approves Lorviqua in previously-treated ALK-positive advanced NSCLC
- Arcus Biosciences and Strata Oncology announce clinical development collaboration for anti-PD-1 antibody

Issue 18 - May 3, 2019

TCL45-18 (279 downloads)

Guest Editorial
Getting beyond the immunotherapy divide: a call to action
Advances in the field of tumor immunotherapy have given great hope for those treating cancer. We are in an era of unprecedented achievements, as evidenced by impressive clinical responses in patients treated with adoptive cell therapy and immune checkpoint inhibitors.
House subcommittee bill gives NIH a $2 billion raise in FY2020—but budget caps must be raised
The Subcommittee on Labor, HHS and Education of the House Committee on Appropriations April 30 marked up a spending bill that gives NIH $41.1 billion, a $2 billion increase over the current level.
Conversation with The Cancer Letter
Hirsch: Syapse collaboration with Amgen will focus on real world evidence and hematologic malignancies
Syapse, a precision medicine company with a data sharing network, has announced a collaboration with Amgen to use analytics and real world evidence to support drug development.
Martine Roussel, Elaine Ostrander, Timothy Ley, Harmit Malik, Staffan Normark and Moshe Oren are among newly elected National Academy of Sciences members
The National Academy of Sciences announced the election of 100 new members and 25 foreign associates in recognition of their distinguished and continuing achievements in original research.
In Brief
- USC and UCSF join Lazarex in IMPACT program to increase diversity in trials
- Elaine Fuchs receives 2019 AACR-G.H.A. Clowes Memorial Award
- Mike Ridinger joins WVU as assistant director of finance and administration
Trials & Tribulations
A comparison of study designs for estimating overdiagnosis in cancer screening
Overdiagnosis is defined as the diagnosis of an asymptomatic cancer that would not have become clinically evident during the person’s lifetime in the absence of screening or similar activities, such as diagnostic imaging tests that reveal “incidentalomas.”
Clinical Roundup
- Study shows 137 million adults in the U.S. suffered medical financial hardship
- Scientists identify genes tied to increased risk of ovarian cancer
- Test allows doctors to determine most effective treatment for breast cancer
- EndoPredict predicts chemotherapy benefit in breast cancer
- Targeted RNA-sequencing detects fusion gene signature in lung cancer
- Biomarker may help predict whether immunotherapy is the right choice in colorectal cancer
Drugs & Targets
- FDA approves sNDA for Tibsovo in AML
- CHMP issues positive opinion on Talzenna for Talzenna in breast cancer indication
- CHMP issues positive opinion for Libtayo for squamous cell carcinoma
- CHMP issues positive opinion for Lynparza in maintenance therapy in ovarian cancer
- CHMP issues positive opinion for Neulasta biosimilar
- Janssen submits sNDA to FDA for Erleada in prostate cancer
- Caris to perform genomic profiling for Hoosier Cancer Research Network Bladder Cancer Study
NCI Trials
NCI Trials for May
The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month.

Issue 17 - Apr 26, 2019

TCL45-17 (361 downloads)

MD Anderson researchers ousted as NIH and FBI target diversion of intellectual property
Three faculty members at MD Anderson Cancer Center were sanctioned for failure to ensure confidentiality of review of NIH grants. The scientists also failed to disclose outside funding, academic appointments, and roles in laboratories outside the U.S.
Conversation with The Cancer Letter
Pisters: “Trust is broken when a grant reviewer decides that an idea should be better done elsewhere”
As MD Anderson investigates reports of wrongdoing by its faculty members, it does so with full understanding that the stakes are as high as it gets: the integrity of the NIH peer review system, MD Anderson’s good name, and the future of cancer research.
Conversation with The Cancer Letter
NIH’s Lauer: “We have contacted over 55 institutions”
MD Anderson is the first institution to address the interrelated problems of theft of intellectual property, violation of ethics of NIH peer review, and researchers’ failure to disclose foreign affiliations and sources of funding.
Conversation with The Cancer Letter
Collins: “Not every one of these investigations is going to reveal something bad, but some of them will”
Stealing data obtained through the NIH peer review process is the most egregious of the cluster of rogue behaviors revealed through ongoing investigations of diversion of intellectual property, NIH Director Francis Collins said in testimony before the Senate Appropriations Committee April 11.
Texas House of Representatives approves two CPRIT measures
The Texas House of Representatives approved two measures that would give the Cancer Prevention and Research Institute of Texas an additional $3 billion to continue operations, and allow the institute to continue funding grants beyond fiscal year 2023.
In Brief
- $15.1M awarded to Rutgers Cancer Institute of New Jersey for redesignation as Comprehensive Cancer Center
- Inova dedicates Inova Schar Cancer Institute; John Deeken named president
- Letter urges exempting FDA rules from review by Congress and the president
- UPMC Hillman Cancer Center joins Beat AML Master Clinical Trial
Clinical Roundup
- Inivata shows positive clinical validation results and real-world utility for its InVisionFirst-Lung liquid biopsy test
- Trial suggests that treatment de-escalation in HER2-positive breast cancer needs to be personalized
- Genetic testing in women diagnosed with breast cancer decreases cost of care nationwide
Drugs & Targets
- FDA approves pembrolizumab plus axitinib for advanced RCC

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