Issue 16 - Apr. 19, 2019
  • 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.

  • 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
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  • 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
Issue 15 - Apr. 12, 2019
  • Your PBM primer: Senate Finance Committee hearing focuses on the mysteries of pharmacy benefit managers—their power and role in rising drug prices

    Pharmacy benefit managers, like climate change, germs and, possibly, God, are all around, and if we could clear a few hours, it would be good to learn enough about them to sustain a cocktail party conversation.

  • Conversation with The Cancer Letter

    Fred Hirsch: New center focuses Mount Sinai’s thoracic oncology programs

    Every year, 800 to 1,000 new patients get referred to The Tisch Cancer Insitute of Mount Sinai lung cancer specialists.

  • An Appreciation

    Paul Godley, oncologist and disparities researcher, dies at 61

    Paul Godley died after a brief illness on March 31. He was the Rush S. Dickson Distinguished Professor of Hematology and Oncology in the School of Medicine, a professor of epidemiology at the Gillings School of Global Public Health, and senior fellow at the Sheps Center for Health Services Research at the University of North Carolina, Chapel Hill.

  • An Appreciation

    Robert Hickman, inventor of the Hickman catheter, dies at 92

    Robert O. Hickman, a pediatric nephrologist and inventor of a catheter that revolutionized care for cancer patients, died on April 4. He was 92.

  • Corrections

    story about robotic mastectomy that appeared in the April 5 issue of The Cancer Letter reported incorrectly that surgeon Stephen A. Chagares had performed robotic mastectomies at Monmouth Medical Center without a surgical trial protocol.

  • In Brief

    • Walter Stadler replaces Susan Cohn as UChicago Dean for Clinical Research; Sonali Smith steps in as interim chief of hem/onc
    • Michael Harrington named EVP and CFO at MSK
    • Ronan Kelly named chief of oncology for North Texas at Baylor Scott & White Health
    • Christine Rini named director of the Cancer Survivorship Institute of the Northwestern Lurie Cancer Center
    • Kathy Albain and Eva Bading honored at Stritch Awards dinner
    • Beverly Teicher named editor-in-chief of AACR’s Molecular Cancer Therapeutics
    • Elizabeth Platz named editor-in-chief of AACR’s Cancer Epidemiology, Biomarkers & Prevention
    • Gateway for Cancer Research gives $1.5M grant for pediatric brain cancer study at Phoenix Children’s Hospital
    • ACLF and LCA merge to create CO2 Foundation for Lung Cancer
  • Funding Opportunities

    DoD Melanoma Research Program funding opportunities for FY19

    The FY19 Defense Appropriation provides $10 million to the Department of Defense Melanoma Research Program to support innovative, high-impact melanoma research.

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  • Clinical Roundup

    • CDC issues key clarification on guideline for prescribing opioids for chronic pain
    • Study: Targeted drug delivery associated with a reduction in health care utilization and cost
    • ASCO forms task force to address rural cancer care gap
    • Survey finds gap between trial availability and patient need in glioblastoma
    • Roswell Park moves forward with expanded study of CIMAvax
  • Drugs & Targets

    • FDA expands pembrolizumab indication for first-line treatment of NSCLC
    • Lynparza approved in EU in breast cancer
    • FDA approves labeling change for Soltamox
    • American Cancer Society study shows need to better identify who may not benefit from aggressive treatment
  • NCI Trials

    NCI Trials for April

    The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month. 

Issue 14 - Apr. 5, 2019
  • Using a robot to perform mastectomies, a New Jersey surgeon sets off a firestorm over surgical outcomes

    How much rigor should be required when surgeons innovate? FDA’s advisory asks for long-term cancer-related data.

    Last August, Stephen A. Chagares, a breast surgeon, made an announcement that startled some of his colleagues at New Jersey’s Monmouth Medical Center.

    At internal meetings and in a press release, Chagares declared that he would perform a robotic mastectomy—a new and relatively untested minimally invasive surgical procedure. According to the press release, his first patient, Yvonne Zucco, 56, was being treated for stage IIa breast cancer.

  • Conversation with The Cancer Letter

    MSK’s Kirstein: Robotic mastectomy not demonstrated to be safe for treatment or prevention of breast cancer

    The Breast Surgical Service at Memorial Sloan Kettering Cancer Center has decided not to adopt—or study—robotic surgical devices in mastectomies, said Laurie Kirstein, a breast surgical oncologist at MSK.

  • Conversation with The Cancer Letter

    MD Anderson’s Hunt and Selber: We will study immediate and long-term outcomes of robotic mastectomy in a prospective trial

    Robotic mastectomy deserves to be studied, because the procedure may improve cancer-related outcomes, surgeons at MD Anderson Cancer Center say.

    Both robotic and open procedures allow the surgeon to follow oncologic principles, said Jesse Selber, professor and director of clinical research at the Department of Plastic Surgery at MD Anderson.

  • Conversation with The Cancer Letter

    Penn’s Brooks: Surgeons should study oncologic endpoints for years, not just 30-day outcomes

    The University of Pennsylvania was planning a short-term trial for robotic mastectomies, but after an FDA advisory,  investigators decided to revise that protocol to include assessment of cancer-related outcomes, said Ari Brooks, director of endocrine and oncologic surgery, director of the Integrated Breast Center at the University of Pennsylvania Health System, and professor of clinical surgery at Penn Medicine.

  • In Brief

    • Amy Abernethy appointed FDA acting chief information officer
    • Zihai Li named director of Ohio State Institute for Immuno-Oncology
    • Eberlein, Tempero, Hoppe, Kolodziej, Burns win NCCN awards
    • Jonas Bergh wins first ESMO Breast Cancer Award
    • Cornelis Melief wins 2019 AACR-CRI Lloyd J. Old Award in Cancer Immunology
    • Rosen, Querfeld awarded $7.5M to develop better treatment for CTCL
    • Olivera Finn receives Richard V. Smalley Memorial Award and Lectureship
    • Feng Yue named director for cancer genomics at Lurie Cancer Center
    • ACS awards research and training grants
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  • Clinical Roundup

    • SU2C-supported trials seek to extend CAR T-cell therapy to solid tumors
    • Imvax announce positive results from clinical trial of IGV-001 vaccine in glioblastoma
    • ADMIRAL trial data Shows Xospata prolongs OS in adults with leukiemia
    • Single agent umbralisib effective for relapsed slow-growing lymphoma
    • Study names six risk factors linked to esophageal cancer 
    • Probiotics linked to poorer response to cancer immunotherapy in skin cancer
    • Rucaparib maintenance therapy shows clinical responses in pancreatic cancer
  • Drugs & Targets

    • Varian ARIA Oncology Information System awarded CancerLinQ certification
    • FDA expands use of metastatic breast cancer treatment to include male patients
    • FDA issues warning letter to genomics lab for marketing genetic test that claims to predict patients’ responses to specific medications
    • Nanobiotix receives European approval for Hensify therapy for sarcoma
    • Opdivo shows long-term survival results in NSCLC
    • Findings from ASCO TAPUR trial presented at AACR meeting
Issue 13 - Mar. 29, 2019
  • Guest Editorial

    NCCN validates path toward de-escalated doses and reduced costs of cancer Drugs

    The ever-rising cost of oncology drugs is doing damage to cancer care on many levels.

    Annual total cost increases are projected to be as much as 20 percent annually. The intense financial pressure these costs place on our patients, even well-insured patients, is well documented.

  • Cancer is a model for drug development, FDA-bound Sharpless says to NCI advisors

    Decades of basic research in oncology are paying off, resulting in an unprecedented number of drug approvals, said Ned Sharpless, the NCI director who is set to become FDA acting commissioner.

  • Guest Editorial

    Congress must commit to sustained increases for NCI

    Cancer is a relentless disease that impacts millions of Americans.

    Just this year more than 1.7 million people in the U.S. are expected to be diagnosed with cancer, and over 600,000 Americans will die from the disease.

  • Letter to the Editor

    Gundry: saguaro cacti do not grow in Texas

    enjoy your publication and read it cover to cover most weeks. But I must point out a glaring error in your recent edition of March 22. The illustrations accompanying the article about the Texas cancer researchers show saguaro cacti. Saguaro cacti only grow in the Sonoran desert of southern Arizona and western Sonora, Mexico, with a few stray saguaros in California. The saguaro cactus does not grow in Texas. It is a common misconception that the saguaro grows throughout the west. The cactus is so unique to Arizona that the saguaro cactus blossom has been named the state flower of Arizona. I thought you should be made aware of this inaccuracy.

  • AACR News

    • Antoni Ribas named AACR president-elect for 2019-2020 term
    • Daniel Von Hoff, Louis Weiner, Nancy Goodman to receive AACR Distinguished Public Service Awards
    • AACR announces 2019 Class of Fellows of the AACR Academy
  • In Brief

    • Sara Hook named associate director for NCI at Frederick
    • GW Cancer Center receives $4M award for technical assistance to CDC National Comprehensive Cancer Control Program grantees
    • Groups urge Congress to close Medicare loophole for colorectal cancer screenings
    • Ali McBride to serve as ACCC president 2019-2020
  • Funding Opportunities

    DoD Kidney Cancer Research Program- Funding Opportunities for FY19

    The FY19 Defense Appropriation provides $20 million to the Department of Defense Kidney Cancer Research Program to support research of exceptional scientific merit in the area of kidney cancer. 

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  • Conversation with The Cancer Letter

    Lee Schwartzberg tells us how three practices banded together to adapt to today’s cancer care and data revolution

    Community oncology needs to adapt to the era of precision oncology and Big Data, said Lee Schwartzberg, executive director of Memphis-based West Cancer Center, who was recently named medical director of OneOncology, a partnership between three oncology practices located in Tennessee and New York.

  • Clinical Roundup

    • Fulvestrant plus Anastrozole extends lives of women with advanced HR+ breast cancer
    • Study finds heating up tumors could make CAR-T therapy more effective
    • Study shows patients with or without cancer use different forms of marijuana
    • Study may explain why immunotherapy not effective for some patients with metastatic melanoma and kidney cancer
  • Drugs & Targets

    • FDA advances policy changes to modernize mammography services
    • FDA issues alert on the investigational use of Venclexta in multiple myeloma
    • Janssen submits application for Darzalex combination in multiple myeloma
    • Breath Diagnostics, Mayo collaborate to develop diagnostic using patients’ exhaled breath to detect lung cancer
    • Oncoceutics and NCI partner to develop ONC206
    • Elicio Therapeutics launches vaccine & immunotherapy platform
Issue 12 - Mar. 22, 2019
Issue 11 - Mar. 15, 2019
Issue 10 - Mar. 8, 2019
Issue 9 - Mar. 1, 2019
Issue 8 - Feb. 22, 2019
  • NCI invites scientists to step up competition for $173 million set-aside for commercialization

    NCI would like you to know that it has a pot of money for commercialization projects—please apply.

    Together, the institute’s Small Business Innovation Research and Small Business Technology Transfer programs are giving out $173 million in fiscal 2019. At NIH, these programs gave out $1.145 billion.

  • Conversation with The Cancer Letter

    Caryn Lerman on leading USC Norris: Team science is where breakthroughs emerge

    Caryn Lerman was named director of USC Norris Comprehensive Cancer Center.

    When she reports to work at USC on March 15, Lerman will be the only behavioral scientist to lead an NCI-designated cancer center. She also will hold the position of professor of psychiatry and the behavioral sciences at the Keck School of Medicine of USC.

  • In Brief

    • NCI’s Rosenberg to receive Szent-Györgyi prize
    • Vale named executive director of HHMI Janelia Research Campus
    • Baylor consolidates cancer center clinics on new McNair Campus
    • Merck to acquire Immune Design
    • Doubrava joins Fox Chase
  • Funding Opportunities

    ASCO invites applications for research based on data from CancerLinQ Discovery

    The American Society of Clinical Oncology is inviting applications for research grants for projects that use data from CancerLinQ Discovery, an offering of ASCO’s CancerLinQ initiative, as a source.

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  • Clinical Roundup

    • Guidelines recommend genetic testing for all people with breast cancer
    • Keytruda + Inlyta reduced risk of death by nearly half compared to sunitinib in RCC
    • OS and PFS for Keytruda in hepatocellular carcinoma did not meet statistical significance
    • Merck expands immuno-oncology program with three phase III trials in prostate cancer
    • Opdivo + Yervoy shows response in pre-treated patients with prostate cancer
    • Janssen announces preliminary results from phase II GALAHAD in prostate cancer
    • Roswell Park researchers identify protein that contributes to racial disparities in prostate cancer
    • AVEO Oncology announces TIVO-3 trial topline results 
    • SCLC may respond to combination of immunotherapy and DNA damage repair inhibitors
    • Study finds melanoma brain metastases immunosuppressive with treatment-resistant metabolism
    • Dasatinib enhances response to checkpoint inhibitors, study finds
    • Integrating heart disease and cancer care could reduce overall health care costs
    • CASSINI Trial publishes data on preventing blood clots in cancer patients
  • Drugs & Targets

    • FDA approves Keytruda for adjuvant treatment of melanoma
    • FDA accepts IND for TR1801-ADC, an ADC targeting cMet positive solid tumors
    • FDA grants priority review to Merck’s sBLA for Keytruda monotherapy in SCLC
    • FDA publishes revised draft guidance for investigational tobacco products
Issue 7 - Feb. 15, 2019
  • Guest Editorial

    Making the case to double NIH

    The decision to double the budget of the National Institutes of Health should be easy, because it will save lives and save our economy simultaneously. The case for NIH is overwhelming, and there is broad bipartisan congressional support. So why is it so challenging?

  • NCI Director’s Report

    Sharpless: Please stay in oncology, don’t stop sending good research ideas to NCI

    The mathematical concepts underlying the challenge NCI is facing today aren’t difficult to grasp. In fact, a 14-year-old in an algebra class should be able to get it, NCI Director Ned Sharpless said to the National Cancer Advisory Board Feb. 12.

  • In Brief

    • Caryn Lerman named director at USC Norris Comprehensive Cancer Center
    • St. Baldrick’s and ACS form partnership focused on pediatric cancers
    • Report calls on US to accelerate the elimination of cervical cancer worldwide
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  • Clinical Roundup

    • Keytruda + Inlyta improves OS, PFS and ORR vs. Sunitinib in RCC
    • Immunotherapy appears better than chemotherapy for skin cancer
    • Group of lymph nodes to determine prognosis for mesothelioma
    • Phase III ARCHES trial shows Xtandi improved PFS in prostate cancer
    • Opdivo + Yervoy shows continued survival benefit in RCC
    • Immunotherapy effective in recurrent glioblastoma
    • Black-white cancer mortality gap nearly eliminated in some age groups
    • Report calls on US to accelerate the elimination of cervical cancer worldwide
  • Drugs & Targets

    • European Commission approves Sprycel + chemo for pediatric
    • FDA grants Priority Review for Keytruda in head and neck squamous cell carcinoma
    • FDA accepts sBLA and grants Priority Review for Bavencio + Inlyta in RCC