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January 2017PDF

 

Prostate Cancer

Study Shows Only Nuclear-Localized AR-V7 Predictive of Benefit for Patients with Metastatic Disease

Investigators from Memorial Sloan Kettering Cancer Center and Epic Sciences published findings in European Urology that only nuclear localization of AR-V7 protein in circulating tumor cells from metastatic castration-resistant prostate cancer patient blood samples is predictive of therapeutic benefit.

 

Pediatric Cancers

Early-phase Study Shows Shrinkage in Pediatric Neural Tumors

In an early-phase clinical trial of a new oral drug, selumetinib, children with the common genetic disorder neurofibromatosis type 1 (NF1) and plexiform neurofibromas, tumors of the peripheral nerves, tolerated selumetinib and, in most cases, responded to it with tumor shrinkage. NF1 affects one in 3,000 people.

 

Breast Cancer

MammaPrint Substantially Impacts How Breast Cancer in Germany is Treated

Agendia Inc. has presented new prospective data demonstrating the strong impact of its 70-Gene Breast Cancer Recurrence Assay, MammaPrint, and the corresponding 80-Gene Molecular Subtyping Assay BluePrint, in clinical decision-making for patients with early-stage breast cancer in Germany.

 

Pancreatic Cancer

Halozyme’s Phase II Study In Advanced Pancreas Cancer Meets Endpoints

Halozyme Therapeutics Inc. reported topline results from the combined analysis of Stages 1 and 2 and Stage 2 alone of its HALO 202 study, a phase II randomized, multi-center clinical trial of lead investigational drug PEGPH20 in combination with ABRAXANE(nab-paclitaxel) and gemcitabine in stage IV pancreas cancer patients.

 

Lung Cancer

Cota Study Suggests Some Patients Are Left Behind in Genomic Revolution

 

Ovarian Cancer

NewVac Meets Primary Endpoints in Phase II Trial of Quisinostat Combination in Platinum-Resistant Disease

 

Brain Tumors

ONC201 Glioblastoma Trial to Expand Based on Promising Initial Results

 

Head and Neck Cancer

Study Finds Biological Explanation for Racial Disparities in Survival for Certain Cancers

 

NCI CTEP-Approved Trials for January

 

Regulatory Actions

Tecentriq receives priority review for treatment of urothelial carcinoma

CCL Jan 2017 - Jan. 25, 2017
Issue 3 - Jan. 20, 2017
  • “Will I still have coverage?” patients ask oncologists as Republicans move to gut Affordable Care Act

    As Congress lays down the groundwork for dismantling the Affordable Care Act, doctors across America are hearing cancer patients speak of their fear of losing access to care if the law known as “Obamacare” is jettisoned without replacement.

  • FDA forms Oncology Center of Excellence, names Richard Pazdur director

    On his last full day as FDA commissioner, Robert Califf announced the formation of the Oncology Center of Excellence and named Richard Pazdur its director.

    The process of forming the center began in June, and Pazdur has been the acting director. Reorganization of the FDA oncology portfolio is an element of the Obama White House Moonshot Initiative.

  • Guest Editorial

    NCI formulary, moonshot and public-private partnerships

    Announcing the NCI Formulary, the Jan. 13 issue of The Cancer Letter includes comments suggesting the road to new therapies will now get “easier” and other comments indicated that industry and/or NCI collaborators will “not provide support other than drug access”.

  • In Brief

    • Richard Goldberg new director of West Virginia University Cancer Institute
    • Justin Klamerus named president of Karmanos Cancer Hospital
    • Werner-Wasik new executive vice chair, radiation oncology integration at Jefferson
    • Northwell Health partners with Indivumed to create cancer research biobank
    • Tempus and University Hospitals/Seidman announce effort to customize treatment
    • Reporting of lung cancer surgery outcomes provides info about quality of care
  • Drugs & Targets

    • Medicinal product designation for TB-403 for medulloblastoma
  • Funding Opportunities

    LUNGevity issues RFA for career development award

    LUNGevity announced a request for applications for translational research for career development awards that will be granted in 2017.

Issue 2 - Jan. 13, 2017
  • NCI develops a “formulary” to make it easier for cancer centers to test drug combinations

    With a simplified tech transfer agreement, six industry partners and 15 compounds (but no dedicated research funds), NCI challenges investigators to think creatively.

  • Conversation with The Cancer Letter

    Simon: The moonshot will continue, but the electronic health record industry must step up

    The National Cancer Moonshot Initiative was created by a memorandum issued by President Barack Obama.

    The wide-ranging public health initiative will cease to exist on Jan. 20—eight days short of a year after it was created—when the keys to the White House are handed over to Donald Trump.

  • In Brief

    • Sakaguchi, Ramsdell, Rudensky win Crafoord Prize for discoveries in immune regulation
    • Gustavo Leone named director of  MUSC Hollings Cancer Center
    • Levine Cancer Institute is first to earn top designation for patient-centered care
    • Martin Edelman joins Fox Chase as hematology/oncology chair
    • Diane Simeone to lead pancreatic cancer center at NYU Langone
    • Mario Contreraz named administrator of IU cancer center clinical trials office
    • Columbia, NewYork-Presbyterian and Life Raft form GIST research partnership
    • NCCN publishes patient education resources for gliomas
    • NIHCM Foundation awards $345K in investigator-initiated research grants
    • LUNGevity Foundation introduces mobile app to help patients manage lung cancer
    • NPR station broadcasts anniversary program on moonshot
    • Goldberg novel is finalist in Jewish Book award
  • Drugs & Targets

    • Merck joins ORIEN
    • Scripps to collaborate with Pfizer to advance DNA-encoded library technology
    • AbbVie announces four new global research collaborations
    • Lilly and Merck expand immuno-oncology collaboration
    • Amgen and Immatics collaborate to develop cancer immunotherapies
    • Philips and Illumina to co-develop integrated genomics solutions for oncology
    • Tecentriq receives priority review for treatment of urothelial carcinoma
    • EMD Serono and MD Anderson enter three-year collaboration
    • MD Anderson and Deerfield Management create company to inhibit autophagy
    • Cologuard earns positive review from Blue Cross Blue Shield Association
    • FDA accepts BLA for Mylan and Biocon’s biosimilar Trastuzumab
    • FDA releases guidance on nonproprietary naming of biologics
Issue 1 - Jan. 6, 2017
  • Doug Lowy on the moonshot, NCI’s invigorated agenda

    As administrations change, cancer research stands in an unusually strong position, NCI Acting Director Douglas Lowy said in an interview with The Cancer Letter.

    “We’re very fortunate that both Republicans and Democrats strongly support biomedical research in general, and cancer research in particular,” Lowy said in a wide-ranging interview. “The leadership of the House and Senate appropriations subcommittees was responsible for the increase in FY16 for the NIH appropriation.”

  • MD Anderson lays off 900 staff members

    The year got off to a bad start for some employees of MD Anderson
    Cancer Center.

    As part of a cost-cutting measure announced Jan. 5, about 900 of them received layoff notices.

    Television crews crowded the parking garages of the Houston hospital, capturing images of teary-eyed people carrying boxes to their cars.

  • Biden plans to create moonshot nonprofit, may focus on drug prices

    After leaving the White House, Vice President Joe Biden plans to consolidate his work on the Cancer Moonshot into an independent, nonprofit organization, while juggling non-cancer programs at two universities.

    Biden aims to continue work on the National Cancer Moonshot Initiative through a new nonprofit that will not be connected to any cancer center or university, according to sources familiar with Biden’s post-administration goals.

  • Introducing a redesign of  The Cancer Letter

    Dear Reader,

    The Cancer Letter is starting 2017 with something we haven’t done in …
    well, ever.

  • In Brief

    • Chi Van Dang named scientific director of Ludwig Institute
    • Vacirca elected COA president
    • Ruckdeschel heads cancer institute at University of Mississippi Medical Center
    • Cassels retires as chief administrator at Winship
    • ACS names three new members to board
    • Kratzke, O’Regan chosen to leadership roles at Big Ten consortium
    • PCORI approves $42 million in funding for comparative studies on healthcare approaches
  • Drugs & Targets

    • AACR project GENIE releases cancer genomic data set
    • Strata Trial study launched with UNC, Alabama cancer centers
    • Foundation Medicine receives FDA approval as companion diagnostic
    • Ionis gets $28 million from AstraZeneca for new cancer drug
    • MaxCyte, Washington University in St. Louis announce collaboration
    • MD Anderson, Affimed collaborate on immunotherapy combination
    • Gradalis, Mount Sinai announce research alliance
    • Phylogica, Genentech extend agreement
    • Senhwa gets FDA orphan drug designation
    • Oncotype DX included in AJCC staging criteria
  • Funding Opportunities

    Addario foundation, IASLC announce grant

    The Bonnie J. Addario Lung Cancer Foundation and the International Association for the Study of Lung Cancer announced the second annual joint fellowship award to support research on the early detection of lung cancer.

December 2016PDF

 

Lung Cancer

Tagrisso Shows Superiority vs. Chemo in EGFR T790M Mutation-Positive Disease

Data from phase III trial showed that Tagrisso (osimertinib) second-line therapy improved progression-free survival by 5.7 months, compared with standard platinum-based doublet chemotherapy (Hazard Ratio [HR]=0.3).

 

Breast Cancer

Lilly Presents Phase II Data on Abemaciclib in Early Breast Cancer

A phase II study of abemaciclib, a cyclin-dependent kinase 4 and CDK 6 inhibitor, met its primary endpoint of reducing expression of Ki67, a biomarker of cell proliferation, after two weeks of treatment.

 

Hematologic Malignancies

Imbruvica Shows Response in 2/3 of Steroid Dependent, Refractory cGVHD Patients in Phase II Study

In a phase II study, ibrutinib (Imbruvica) demonstrated clinically meaningful and durable responses and reduced symptom severity, with an overall response rate of 67% in patients with cGVHD.

 

Regulatory Actions

FDA Approves Indications for Rubraca and Avastin

 

KRAS

Cellular Immunotherapy Targets a Common Human Cancer Mutation

 

Head and Neck Cancer

Immune Response to HPV Has Impact on Prognosis

 

 Pain Management

Opioids Not Helpful in Treating Chronic Pain, Geisinger Study Finds

 

NCI CTEP-Approved Trials for December

CCL Dec 2016 - Dec. 22, 2016
13651
Issue 46 - Dec. 16, 2016
  • FDA Finds Lapses in Reporting of Patient Harm, Deaths Resulting from Medical Devices in Hospitals Nationwide

    After a broad survey of reporting standards at hospitals across the U.S., an FDA investigation recently concluded that the vast majority of the 17 institutions inspected did not file timely reports of injuries and deaths caused by medical devices.

    The inspections earlier this year were triggered by public scrutiny of power morcellation, a surgical procedure known to spread undetected uterine cancer via the device’s spinning blades, as well as by reports of infections associated with contaminated duodenoscopes, flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine.

  • Conversation with The Cancer Letter

    FDA: For Hospitals that Significantly Violated Federal Adverse Event Reporting Requirement, No Additional Action Necessary

    In a 17-institution inspection sparked by reports of patient harm and death resulting from power morcellators and contaminated duodenoscopes, FDA found that nearly all hospitals surveyed either failed to report adverse events or didn’t have proper reporting and documentation procedures in place.

  • Hackensack Cancer Center, MSKCC Form Business, Clinical Partnership in New Jersey

    Memorial Sloan Kettering Cancer Center and Hackensack Meridian Health announced a 10-year partnership deal that, in its initial stages, will involve developing joint standards of care that will be applied across their operations.

  • Obama Signs Cures Act, Funding Biden’s Moonshot and Boosting NIH, NCI, FDA Budgets Over 10 Years

    President Barack Obama Dec. 13 signed the 21st Century Cures Act, a bill that changes regulatory standards at FDA, slates additional research funds for NIH, and authorizes $1.8 million over seven years for Vice President Joe Biden’s National Cancer Moonshot Initiative.

  • Editorial

    The Year of the Moonshot

    The moonshot, The Cancer Letter’s biggest area of coverage of 2016, continues into 2017.

    With the passage of the 21st Century Cures Act, the cancer moonshot initiative has been authorized at $1.8 billion over seven years. The Cures Act also authorizes $500 million over the next decade for FDA to streamline drug and device approval processes (The Cancer Letter, Dec. 10).

  • In Brief

    • Bertagnolli elected ASCO president
    • CMS abandons Medicare Part B payment experiment
    • Maki joins leadership of Northwell Health and Cold Spring Harbor
    • Neufeld named clinical director, physician-in-chief & EVP at St. Jude
    • Anderson appointed CEO of Genentech
    • Brown gives $30 million to IU immunotherapy center
    • Mulva family donates $75 million to UT Austin, MD Anderson
    • Collins receives FASEB Public Service Award
    • Proton Partners to build new cancer center at Thames Valley Science Park, UK
    • ACCC launches online resource for metastatic breast cancer
  • Drugs & Targets

    • Keytruda becomes first anti-PD-1 therapy to receive a CHMP positive opinion for previously untreated NSCLC
    • Nintedanib receives orphan drug designation for mesothelioma
    • ABTL0812 receives orphan drug designation for Pancreatic Cancer
Issue 45 - Dec. 9, 2016
  • DePinho Accepts Responsibility As MD Anderson’s Losses Grow

    Operating losses at MD Anderson Cancer Center ballooned again in October—swelling to $60.9 million on top of September’s $41.5 million.

    Losses for the first two months of fiscal year 2017 add up to $102.4 million, and the institution’s executives are scrambling to cut costs, boost revenues, and shore up faculty morale.

  • Senate Approves 21st Century Cures; CR Slates $300M for NCI and Moonshot

    The Senate approved the 21st Century Cures Act, a wide-ranging bill that authorizes $1.8 billion over seven years for cancer research as well as $500 million over the next decade for FDA to streamline drug and device approval processes.

  • Being an Acting Director, NCI’s Lowy Isn’t Required to Submit Resignation

    Doug Lowy will continue to lead NCI in his role as acting director in 2017 unless president-elect Donald Trump decides to appoint a different, new director.

  • In Brief

    • Drebin appointed chair of surgery at MSKCC
    • Brown named director of Inova Center for Drug Discovery and Development and Targeted Therapeutics
    • Vogelstein to receive the KNAW Bob Pinedo Cancer Care Award
    • Surgeon General issues report on electronic cigarettes
    • Zinner elected chair of American College of Surgeons board of regents
    • Jenkins retires from FDA Office of New Drugs
    • Tempus, Abramson Cancer Center collaborate on immunotherapy
    • Parker Institute, CRI form collaboration on neoantigens
    • AbbVie, Northwestern and Hopkins announce collaborations
    • GW launches the GW Cancer Center
    • St. Jude marathon raises $10 million
    • Coleman named VP of medical affairs at GenomOncology
    • Hesse named president, CEO of CTCA Philadelphia center
    • Hillman, Patti, Weinreb receive ACR Gold Medal
    • UT Health Northeast in Tyler, TX, joins MD Anderson Network
  • Drugs and Targets

    • Avastin plus chemo gets FDA approval for a type of ovarian cancer
    • EC Grants Conditional Approval for AbbVie’s Venclyxto for CLL
    • Amgen and Allergan seek EMA approval of biosimilar bevacizumab
    • Whole genome sequencing center established in Singapore
Issue 44 - Dec. 2, 2016
  • 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
November 2016PDF

 

Guidelines

New Evidence-Based Guideline on HER2 Testing for Patients with Gastric Cancer

The College of American Pathologists, the American Society for Clinical Pathology, and the American Society of Clinical Oncology released an evidence-based clinical practice guideline on human epidermal growth factor receptor 2 testing for patients with gastroesophageal cancers.

 

Urothelial Cancer

Phase III Keytruda Study Shows Better OS vs. Chemo for Advanced Urothelial Cancer

Merck announced that the phase III KEYNOTE-045 trial investigating the use of Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall survival.

 

Regulatory Actions

FDA Approves New Indications for Darzalex, Keytruda, Opdivo

Janssen Biotech said FDA approved Nov. 21 daratumumab (Darzalex) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

 

Multiple Myeloma

Study met Primary Endpoint of Non-Inferiority Versus Zoledronic Acid in Delaying Skeletal-Related Events

Amgen announced that a phase III study evaluating XGEVA (denosumab) versus zoledronic acid met the primary endpoint of non-inferiority (hazard ratio = 0.98, 95 percent CI, 0.85 – 1.14) in delaying the time to first on-study skeletal-related event in patients with multiple myeloma.

 

Prostate Cancer

 

Testicular Cancer

High-Dose Chemo and Stem Cell Transplant Cures Most Relapsed Testis Cancer

 

Bladder Cancer

Positive Survival Results from Apatorsen Phase II Trial in Metastatic Bladder Cancer

 

Melanoma

 

Immunotherapy

Nektar Phase II Study: Anti-tumor activity in 7/18 evaluable patients with solid tumors

 

NCI CTEP-Approved Trials for November

CCL Nov 2016 - Nov. 29, 2016
Issue 43 - Nov. 18, 2016
  • 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
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