Home – Page 28 – The Cancer Letter

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

Issue 16 - Apr 19, 2019

TCL45-16 (639 downloads)

Real World Evidence
How FDA, Pfizer, and Flatiron Health did it
Approval of Ibrance for men affords a glance at use of real world data
Real world data played a role in FDA’s recent decision to expand the indications for Pfizer’s drug Ibrance (palbociclib) to include men.
Real World Evidence
How real world evidence was used to support approval of Ibrance for male breast cancer
We posed the same 10 questions to FDA, Pfizer and Flatiron Health.
NCI advisors approve eight concepts, including three Cancer Moonshot concepts
The NCI Board of Scientific Advisors approved eight new Requests for Applications, Requests for Proposals, and PAR—a program announcement reviewed in the institute—concepts at a meeting March 25, including three new Cancer Moonshot concepts.
Letters to the Editor
The Cancer Letter is grateful to Mr. Fotopoulos and Mr. Thomson for writing to us.
Because of incorrect information provided to us, The Cancer Letter reported erroneously that Dr. Stephen Chagares had performed two robotic mastectomies without a protocol (The Cancer Letter, April 5).
In Brief
- William Cance named interim director of University of Arizona Cancer Center as Andrew Kraft steps down
- Jefferson, Temple extend due diligence period for negotiations over sale of Fox Chase
- Dany Habr named chief medical officer at Pfizer Oncology
- Lisa Kachnic named chair of Columbia Department of Radiation Oncology, chief of Radiation Oncology Service at NY-Presbyterian/Columbia University Irving Medical Center
- ASCO & The Conquer Cancer Foundation announce merit awards
- IMF co-founders Susie and Brian Durie receive honorary doctorate from Vrije Univesiteit Brussel
- Margo Shoup to join Western Connecticut Health Network as network chair of cancer service line
Clinical Roundup
- ACP screening guidance calls for two-year interval between mammograms for women at average breast cancer risk
- Artificial intelligence performs as well as experienced radiologists in detecting prostate cancer
- Mount Sinai launches clinical trial of new imaging device for head and neck cancer surgeries
- Cervical cancer subtype rising in some sub-populations
Drugs & Targets
- FDA approves Balversa for urothelial carcinoma with FGFR genetic alterations
- FDA expands pembrolizumab indication for first-line treatment of NSCLC
- Aprea Therapeutics receives FDA Fast Track and Orphan Drug designations for APR-246 for MDS
- Intensity Therapeutics receives Fast Track designation for development of INT230-6 in breast cancer
- Kitov announces milestone in FameWave acquisition
- Stanford partners with Notable and Tempus to make rapid personalized treatment in blood cancer patients
- OncoSec anounces collaboration with Duke to study TAVO + plasmid DNA vaccines in breast cancer
- Roswell Park selects Circuit Clinical as collaborator for CIMAvax clinical trial

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