Issue 16 - Apr. 19, 2019
TCL45-16 (267 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

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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
TCL45-15 (232 downloads)

  • 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

    A 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
TCL45-14 (383 downloads)

  • 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