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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
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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
Issue 42 - Nov. 11, 2016
  • 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
Issue 41 - Nov. 4, 2016
  • MD Anderson Projects $450 Million Loss in Fiscal 2017

    MD Anderson Cancer Center lost $267.1 million on its operations in fiscal 2016. Now, a month into fiscal 2017, America’s largest cancer center is on track to lose $400 million to $450 million.

    In a confidential report intended for department chairs, MD Anderson’s administration attributes the operating loss to four factors:

    • Epic system (tools, reports, technology fixes);

    • Providers – Capacity (Mondays & Fridays; weekends for select services; services at right location);

    • Demand (wait times, rate of incoming calls/requests to set up appointments);

    • Insurance coverage.

  • Cancer Moonshot Research Dollars Must Go to NCI—Not NIH—Groups Say

    Nearly 50 cancer-related organizations urged Congressional leaders to ensure that funds slated for research in the National Cancer Moonshot Initiative go directly to NCI—as opposed to NIH or any other federal entity.

    The letter, dated Nov. 3, was authored by One Voice Against Cancer, a broad coalition that convenes on national funding and policy issues in oncology.

    “It is … imperative that funding provided for Cancer Moonshot research be specifically directed to NCI,” the letter states.

  • San Antonio’s CTRC Joins MD Anderson Network

    The UT Health Science Center at San Antonio and MD Anderson Cancer Center announced an affiliation to create a cancer care program in San Antonio.

    Under the agreement announced earlier this week, MD Anderson will join forces with the Cancer Therapy & Research Center of the UT Health Science Center.

  • Guest Editorial

    A Countdown: Top 10 Problems With NCI-Designated Cancer Centers

    For nearly a half century, much of the “war on cancer” has been fought at NCI-designated cancer centers, the 69 major medical schools and free-standing research institutes have this designation.

    All the big names are there: UCLA, Stanford, Memorial Sloan Kettering, Dana-Farber, MD Anderson, etc.  The NCI “designates” centers for containing organizational structures that create synergies among cancer researchers.  Designated centers promote multi-disciplinary collaborations, provide scientific tools too expensive for individual laboratories (core resources), incentivize translation of scientific ideas into therapies, etc.

  • In Brief

    • Inova and UVA partnership to establish NCI-designated comprehensive cancer center
    • Eckhardt named director of LIVESTRONG Cancer Institute
    • Kachinc elected president of American Board of Radiology
    • O’Connell receives ACCC Research Award; Presant receives David King Award
    • ASCO and Innovative Oncology Business Solutions collaborate on medical home program
    • UPMC collaborates on radiation therapy center in Ireland
    • Schulman IRB launches central oncology review
    • Engleka joins Burson-Marsteller
    • Cincinnati practice joins US Oncology Network
    • Merck and ACS publish report on Global burden of cancer in women
  • Drugs and Targets

    • Roche receives FDA approval for Tecentriq complementary diagnostic in NSCLC
    • BMS receives Health Canada conditional approval for Opdivo-Yervoy combination
    • Hoffmann-LaRoche’s Alecensaro receives Health Canada approval NSCLC
    • Novogen and Genentech enter in commercialization agreement got glioblastoma multiforme drug candidate
    • NICE recommends Eribulin for locally advanced metastatic breast cancer
Issue 40 - Oct. 28, 2016
  • ACA Premiums Up by 25%—Why?

    How Will Oncology Be Affected?

    HHS officials earlier this week announced that health insurance premiums under the Affordable Care Act plans will, on the average, increase by 25 percent next year.

    Experts say that this could be happening at least in part because patients who signed up for the ACA exchanges turned out to be sicker and older than underwriters originally anticipated.

  • Public Health Groups Sue to Force FDA to Mandate Graphic Warnings on Cigarettes

    Eight public health and medical groups filed suit in federal court to force FDA to issue a final rule requiring graphic health warnings on cigarette packs and advertising.

    The lawsuit was filed in Boston by the American Academy of Pediatrics, the Massachusetts Chapter of the American Academy of Pediatrics, the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids, Truth Initiative, and several individual pediatricians.

  • COA Reports More Attrition of Cancer Clinics

    Since 2008, 1,581 community oncology practices have closed, been acquired, merged, or are struggling to stay open, according to the 2016 Community Oncology Practice Impact Report.

    “An average of 3.6 practices have closed per month since COA began tracking this data,” said Bruce Gould, president and medical director of Northwest Georgia Oncology Centers, and president of the Community Oncology Alliance, in a statement.

  • Drugs and Targets

    • Keytruda Is First Checkpoint Inhibitor To Get Approval for Front Line NSCLC
    • Xtandi Receives FDA Approval for Supplemental New Drug Application
    • YS-ON-001 granted orphan drug designation by FDA
  • In Brief

    • Achilefu Gets DOD Distinguished Investigator Award in Breast Cancer
    • Gov. Andrew Cuomo announced NY-Cuba Partnership for U.S. Clinical Trial of a Cuban Immunotherapy
    • Vanderbilt University Medical Center, Meharry Medical College, and Tennessee State University receive continued federal funding from U54 Partners in Eliminating Cancer Disparities Grants 
    • Grace Lu-Yao joins the Sidney Kimmel Cancer Center at Jefferson
    • Sharon Byers named chief development and marketing officer of the American Cancer Society
    • Emory St. Joseph’s Hospital expands the Winship Cancer Institute
    • Ellen and Gary Davis give $2 million to Weill Cornell Medicine 
    • Varian Medical Systems and McKesson Specialty Health announce a strategic agreement
Issue 39 - Oct. 21, 2016
  • Biden Delivers Task Force Report—

    Five Moonshot Goals in Cancer

    Vice President Joe Biden and the National Cancer Moonshot Task Force published their final reports Oct. 17, summarizing the moonshot’s achievements, and outlining five strategic goals and action plans for the years to come.

    The two reports conclude the 2016 National Cancer Moonshot Initiative, and the Obama administration’s efforts to develop a national conversation on cancer research.

  • Obama: The Moonshot, “Architecture and a Framework” for Cancer Research

    President Barack Obama accepted Vice President Joe Biden and the National Cancer Moonshot Task Force’s reports—blueprints for how the federal government should focus on cancer research, oncology bioinformatics, and patient access and care over the next few years.

    “This all comes down to, ‘How does it impact patients?’ And so Joe, I think, has done a great job in engaging people who are going through battling cancer right now, and finding ways that we’re not just coming up with cures, but we’re also making sure that these systems are set up so that they’re easier for people to access,’ Obama said at a press conference Oct. 17.

  • LLS Starts Beat AML Master Trial

    After four decades of few improvements in the treatment for acute myeloid leukemia, the Leukemia and Lymphoma Society has launched a precision medicine trial to identify targeted treatments for patients with AML.

    The society’s trial—called Beat AML Master Trial—was announced by Vice President Joe Biden Oct. 17 at a White House event rolling out Moonshot-related initiatives.

  • Califf, Bach, Jasin, Offit, Venter Among New Members of NAM

    The National Academy of Medicine announced today the election of 70 regular members and nine international members during its annual meeting. 

    The NAM Articles of Organization stipulate that at least one-quarter of the membership is selected from fields outside the health professions.

  • In Brief

    • Fuchs Named Director at Yale
    • Cox Wins Statistics Top Prize
    • David Cella received National Academy of Medicine Gustav O. Lienhard Award
    • Marcio Fagundes and Michael Chuong joined the Miami Cancer Institute at Baptist Health South Florida’s integrated Radiation Oncology Department
    • The Robert H. Lurie Comprehensive Cancer Center announced a partnership that will make Tempus as a preferred partner
    • Leidos Biomedical Research, Inc. awarded ATCC
    • Carol Burke elected president of the American College of Gastroenterology
    • The Pan Mass Challenge raised $47 million
    • The Scripps Research Institute and the California Institute for Biomedical Research announced the signing of a strategic affiliation
  • Drugs and Targets

    • Lartruvo gets accelerated approval for sarcoma
    • Tecentriq approved for a type of NSCLC
    • Venclyxto granted a positive opinion from the European Committee for Medicinal Products for Human Use
    • Onivyde in combination with 5-fluorouracil and leucovorin received marketing authorization from The European Commission
    • CDC recommended 11-to-12-year-olds receive two doses of HPV vaccine
    • IBM Watson Health and Quest Diagnostics launched IBM Watson Genomics from Quest Diagnostics
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