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Issue 44 - Dec 2, 2016

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House Passes 21st Century Cures Act, Slating $4.8 Billion for NIH, Moonshot
The House of Representatives has approved a revised version of the 21st Century Cures Act, a comprehensive $6.3 billion health care reform measure that would fund the National Cancer Moonshot Initiative and amend FDA standards for regulating drugs and devices.
Just as Feared: House Version of Cures Bill Gives Moonshot Money to NIH Director
In an unusual move, the National Cancer Advisory Board fired off a letter urging Congress to authorize additional “moonshot” funds, and—just as importantly—to place these new funds in the NCI budget.
The NCAB letter, dated Nov. 22, was likely motivated by insider accounts of a drive by top NIH officials to intercept these new dollars and place them under the purview of the NIH director (The Cancer Letter, Nov. 4).
Letter To The Editor
Pressures Notwithstanding, MD Anderson Projects Positive Margin in Fiscal 2017
Dear Editor,
It was with disappointment that I read the Nov. 4 issue of The Cancer Letter. I feel it is my duty to respond to address inaccuracies that are not only potentially damaging to The University of Texas MD Anderson Cancer Center, but might unnecessarily scare patients who are coming to our institution for cancer care and hope.
In Brief
- Tuveson named director of Cold Spring Harbor
- City of Hope and Translational Genomics Research Institute to collaborate on precision medicine
- $50 million to fund prostate cancer research among veterans
- MSKCC to offer surgery outside Manhattan
- NCCN guidelines & app help patients combat nausea and vomiting
- NCCN imaging appropriate use criteria published for 15 guidelines
- Guardant360 the preferred liquid biopsy test at Northwestern University
- Dietrick named chief value officer at Chesapeake Urology
- City of Hope’s Salgia receives 2016 Asclepius Award
- Southern Research awarded NCI contract
Drugs & Targets
- Darzalex receives FDA approval for multiple myleoma
- Iclusig receives full FDA approval for CML
- Athenex and Lilly enter clinical collaboration
- BMS, Enterome collaborate on microbiome-derived biomarkers
- First computer-aided detection system gets FDA approval
- Avelumab accepted for priority review by FDA

Issue 43 - Nov 18, 2016

CL42-43 (421 downloads)

Republicans Ditch 2017 Appropriations To Tailor Spending to Trump Priorities
The House and Senate leadership postponed appropriations for fiscal 2017 in favor of a second continuing resolution that runs through March 31, 2017.
The move Nov. 17 is likely a signal that Congressional Republicans are hoping to start the budget process anew, tailoring it to the priorities of the administration of president-elect Donald Trump.
MD Anderson Sues Billionaire Over Using the Word “Moonshot”
Earlier this year, billionaire Patrick Soon-Shiong created considerable confusion by launching a cancer “moonshot” program at the same time that President Barack Obama announced an initiative that went by pretty much the same name.
On Jan. 11, a day before Obama announced his program during the State of the Union Address, Soon-Shiong, in a draft press release, claimed that the White House, NIH, FDA and pharmaceutical companies have united to launch the “Cancer MoonShot 2020,” an immunotherapy clinical trials program that Soon-Shiong had designed.
In Brief
- Libutti Named Director at Rutgers Cancer Institute
- Beau Biden endowed chair established at MD Anderson
- Feinstein Institute researcher introduces app to help patients with treatment options
- Cedars-Sinai adds radiation oncology with treatment center
- Guideline on HER2 Testing for Patients with Gastric Cancer
- University of Pennsylvania implements tobacco-free campus policy
- President’s Cancer Panel publishes report on connected health
- Maintenance of certification points offered through QOPI
Drugs & Targets
- Amgen, Allergan submit application for biosimilar bevacizumab
- Midostaurin receives FDA priority review
- Napabucasin granted Orphan Drug Designation

Issue 42 - Nov 11, 2016

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Conversation with The Cancer Letter
FDA Eager to Approve PD-1 and PD-L1 Drugs in Novel Combinations, New Settings
In an in-depth interview with The Cancer Letter, an FDA official clarified the agency’s criteria for approval of drugs that target PD-1 and PD-L1.
Last month, The Cancer Letter reported that there are 803 registered clinical trials testing 20 PD-1 and PD-L1 drugs. These trials have slots for 166,736 patients. (The Cancer Letter, Oct. 7).
The scope of this development effort appears to be unprecedented.
What the Trump Presidency Means for Cancer Care, the ACA, and the Moonshot
President Barack Obama’s legacy health care programs—the Affordable Care Act, and the National Cancer Moonshot Initiative—have been thrown into uncertainty.
Hours after Republican Donald Trump became president-elect of the United States, Washington is left in a muddle: hopeful Democratic appointees who expected to join Hillary Clinton’s ranks ended up empty-handed. At stake is leadership at federal agencies, including the HHS, NIH, NCI, and FDA.
Fred Hutchinson Opens Cellular Immunotherapy Clinic
Fred Hutchinson Cancer Research Center has opened a first-of-its-kind clinic focused on cellular-based immunotherapies for cancer patients in clinical trials.
The Bezos Family Immunotherapy Clinic will allow researchers to conduct twice as many immunotherapy trials in the next year in pursuit of speeding cures for cancer, officials said.
In Brief
- Peter O’Dwyer elected group co-chair elect of the ECOG-ACRIN
- Charles Drake joins NY-Presbyterian/Columbia as director of genitourinary oncology. associate director at the Columbia Cancer Center, co-director immunotherapy program.
- William Cance joins University of Arizona Cancer Center as deputy director
- Craig Reynolds to retire as as director of the NCI Office of Scientific Operations at Frederick
- Elisabeth Heath, of Karmanos, receives the Michigan Cancer Consortium’s inaugural Champion Award
- Felipe Suero joins Department of Anesthesiology at Fox Chase
- Valierie Armstead joins Fox Chase Cancer Center as professor in anesthesiology
- Susan Rawl, of Indiana University School of Nursing and IU Cancer Center, receives $2.6M from PCORI for colorectal cancer screening research
- IU School of Nursing establishes Champion Center for Cancer Control Research, named after Distinguished Professor Victoria Champion.
- NCCN launches Just Bag It campaign for safe handling of vincristine
- Weill Cornell Medicine and New York Genome Center receive a NCI grant worth $490,000-a-year five-year grant for joint cancer genomics data center
- John Wayne Cancer Institute and Singapore’s Clearbridge BioMedics to establish a circulating tumor cell center
- St. Baldrick’s Foundation provides infrastructure grants to nearly 40 childhood cancer institutions
Drugs and Targets
- Opdivo receives FDA approval for recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy
- Amgen and Janssen Biotech to evaluate combination of Amgen’s Kyprolis and Janssen’s Darzalex in multiple clinical studies in multiple myeloma
- Hopkins and BMS announce five-year collaboration to study resistance to checkpoint blockers and develop combination immunotherapies.
- Mylan and Biocon submit BLA for biosimilar trastuzumab
- FDA has accepts Genentech’s BLA for a subcutaneous formulation of rituximab in blood cancer indications
- LEE011, Novartis’s selective cyclin dependent kinase inhibitor, granted FDA Priority Review
- Verastem licenses exclusive worldwide rights to develop and commercialize Infinity’s oncology product candidate duvelisib.
- VENTANA ALK (D5F3) CDx gets FDA approval to use on the VENTANA BenchMark ULTRA automated slide stainer
Funding Opportunities
- SU2C and Genentech form “Catalyst” to provide research funding and access to compounds in effort to find new indications
- SU2C makes $7.5 million in grants available to early-career scientists focusing on immuno-oncology