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ISSUE 18 – May 6, 2016PDF

art 42-18 fda on the moon final

Virtual is Not Enough

FDA’s Critics Call for Full Integration of Oncology Center Under Biden’s Moonshot

The White House moonshot to accelerate progress in cancer research directs FDA to consolidate its oncology portfolio.

However, oncology insiders say the manner in which the presidential initiative will be implemented could make the difference between political balderdash and genuine improvement in FDA regulation of cancer therapies.

The entire controversy boils down to the interpretation of one word: Virtual.

Moonshot Director Addresses AAADV Workshop

Greg Simon, executive director of the cancer moonshot task force, addressed the FDA-sponsored workshop for Accelerating Anticancer Agent Development and Validation in North Bethesda, Md., May 4.

He discussed the goals for the moonshot initiative, how the program could fit into the next presidential administration, and how to take the project international.

Slamming the Door

Part XI: Gilman’s Teachable Moment

During our first conversation in the spring of 2012, Gilman said that he would go public unless he received assurances that CPRIT would retain its integrity after his departure.

He wanted guarantees that the structure he built would not be turned into a political pigsty. With guarantees being hard to come by, it was obvious that he would end up slamming the door hard. Publicly.

FDA to Regulate All Tobacco Products, Including E-Cigs, In Historic Expansion

FDA issued final regulations for all tobacco products, including electronic cigarettes, cigars and hookah. The rules, with provisions aimed at restricting youth access and requiring premarket clearance for new products, will take effect Aug. 8.

The federal regulations include: not allowing tobacco products to be sold to persons under the age of 18, both in person and online; requiring age verification by photo ID; not allowing the selling of covered tobacco products in vending machines, unless in an adult-only facility; and not allowing the distribution of free samples.

National Academy of Sciences Elects 105 Members

The National Academy of Sciences elected 84 new members and 21 foreign associates from 14 countries in recognition of their distinguished and continuing achievements in original research.

Those elected today bring the total number of active members to 2,291 and the total number of foreign associates to 465. Foreign associates are nonvoting members of the academy.

Funding Opportunity

CureSearch Taking Applications
For Pediatric Research Awards

CureSearch for Children’s Cancer is taking applications for its International Grand Challenge Awards addressing three challenges in pediatric cancer treatment. The awards will be worth between $2 million and $3 million.

In Brief
  • American Cancer Society and CVS Health launch three-year antismoking campaign
  • Pershing Square Sohn Research Alliance funds seven young investigators

  • Sean Parker recognized by the Vatican for philanthropic work

  • Richard O’Reilly receives inaugural Society of Memorial Sloan Kettering Prize

  • David Weiner receives professorship and grant from W.W. Smith Charitable Trust

  • Canadian Cancer Clinical Trials Network launches national awareness campaign

Drugs and Targets
  • Eribulin receives EU approval in liposarcoma

  • Health Canada approves Lynparza in ovarian cancer

  • CHMP issues positive opinions for Imbruvica and Afinitor

  • AstraZeneca and Foundation Medicine to collaborate on diagnostic assays

  • AbbVie and CytomX Therapeutics to collaborate on probody drug conjugates


20160506 - May. 6, 2016
April 2016PDF


Head and Neck Cancers

Opdivo Extends OS in Phase III Squamous Cell Carcinoma Trial

A phase III trial of PD-1 inhibitor Opdivo showed significant survival benefit at one year—compared to investigator’s choice of methotrexate, docetaxel or cetuximab—in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

Patients treated with Opdivo (nivolumab) experienced a 30 percent reduction in the risk of death, with a median overall survival of 7.5 months (95% CI: 5.5-9.1) compared to 5.1 months (95% CI: 4.0-6.0) for investigator’s choice (HR=0.70 [97.73% CI: 0.51-0.96] p=0.0101).

The one-year survival rate for Opdivo was 36 percent compared to 16.6 percent for investigator’s choice. The safety profile of Opdivo in CheckMate-141 was consistent with prior studies, with no new safety signals identified.



    Opdivo-Yervoy Combination Demonstrates Two-Year Survival Rate of 69 Percent

    Overall survival data from CheckMate-069, a phase II trial of a Opdivo and Yervoy combination regimen in patients with previously untreated advanced melanoma, demonstrated a two-year overall survival rate of 69 percent compared to 53 percent for Yervoy alone (HR=0.58 [95% CI: 0.31-1.08]) in patients with BRAF wild-type advanced melanoma.

    CheckMate-069 evaluated 142 patients with previously untreated unresectable or metastatic melanoma who received either the Opdivo and Yervoy combination regimen (n=95) or Yervoy alone (n=47). The trial included patients with BRAF wild-type and BRAF V600 mutation-positive melanoma, and randomization was stratified by BRAF mutation status.


      Drugs and Targets

      FDA Grants Accelerated Approval To Venclexta Tablets in CLL

      FDA granted accelerated approval to Venclexta tablets (venetoclax) for patients diagnosed with chronic lymphocytic leukemia with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.

      The indication was approved based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.



        Ovarian Cancer


        Prostate Cancer

        Study: SBRT Delivers 98.6% Cure Rate at Five-Year Followup


        Soft Tissue Sarcoma

        Researchers: Radiation After Surgery Benefits Older Patients More than Younger Patients


        NCI CTEP-Approved Trials for the Month of April


        Letter to the Editor

        GOG Foundation Sends Rebuttal Letter to Oncolytics Biotech

        20160502 - May. 2, 2016
        ISSUE 17 – April 29, 2016PDF

        Guest Editorial

        The Moonshot: A View from Europe

        By Peter Boyle

        “And I believe we need a moonshot in this country to cure cancer.”

        With these words, Vice-President Joe Biden gave the first public hint of a new specific, major program to be launched and funded by the U.S. government.

        President Barack Obama reiterated this development in his State of the Union address announcing a new national effort to get it done and placing Vice President Biden as leader of this initiative.

        The appointment of Vice President Biden to head the initiative is an inspired choice.

        Of course, let’s not forget that in 1971 President Richard Nixon launched a not dissimilar initiative and yet 45 years later, there still remains an on-going war against this feared group of diseases, despite progress in many aspects. Times change, knowledge advances, and there are many signs that this new initiative holds out a better chance of success.


        NCI’s New Genomic Platform Seeks to Enable Data Sharing for Biden’s Moonshot

        NCI is preparing to open the Genomic Data Commons, a $20 million big data endeavor aimed at making raw genomic data publicly available.

        The GDC, NCI’s largest bioinformatics effort since the ill-fated caBIG, will go live June 1. The database will be interoperable and publicly available to qualified researchers. Anyone will be able to submit data for consideration.

        While work on the GDC began over two years ago, the initiative is being launched at a time when leading oncology groups are positioning themselves to play a central role in the White House’s moonshot initiative.

        Conversation with The Cancer Letter

        NCI’s Staudt and Kibbe: Data Commons Will Publish Annotated Raw Genomic Data

        The Genomic Data Commons, NCI’s latest big data project, is poised to become a major player in oncology bioinformatics when it opens June 1.

        The GDC aims to become oncology’s go-to database for comprehensive, raw genomics information. NCI officials said this sets the GDC apart from other bioinformatics projects, which are vying to play a role in the White House moonshot initiative.

        “When the other groups are sharing the data, what they are doing is sharing very derived data that is divorced from the actual data,” said Louis Staudt, director of NCI’s Center for Cancer Genomics. “The GDC is doing something different.”

        Capitol Hill

        Senate Committee Looks to Fund Medical Innovation Legislation

        Over 150 organizations sent an open letter to the leaders of the Senate Health, Labor, Educations and Pensions Committee, supporting them for advancing legislation that will form the basis of the Senate’s version of the 21st Century Cures Act, which passed the House last year.

        The Senate committee has passed 19 bills since February—collectively referred to as medical innovations legislation—which include agreements on NIH funding, support for the Precision Medicine Initiative, and changes to FDA and NIH hiring power. Now, the committee has to work to find ways to pay for the programs before sending the bills to the full Senate.

        PCORI Approves $44.4 Million for 21 Research Studies

        The Patient-Centered Outcomes Research Institute approved $44.4 million in funding for 21 new patient-centered comparative clinical effectiveness research studies.

        Several studies will focus on cancer, including comparing ways to improve colorectal cancer screening, develop a more patient-centered approach to assessing the quality of care for people with cancer, and assessing the effectiveness of different treatment strategies for ductal carcinoma in situ among older women.

        In Brief
        • Jennifer Pietenpol named executive vice president for research at Vanderbilt

        • Margaret Foti named an honorary member of the Oncology Nursing Society

        • John Weston named chief operating officer of the Prostate Cancer Foundation

        • Al Benson III elected president of National Patient Advocate Foundation executive board

        • Avinash Desai named vice president at Eisai Inc. 

        • MD Anderson Cancer Center names eight Sabin Family Fellows

        • NCCN publishes patient education materials for NHL

        • Kids v Cancer launches Compassionate Use Navigator tools

        • Albert Einstein College of Medicine enters agreement with Jiangsu Hengrui Medicine

        • Wistar Institute and Cormorant Pharmaceuticals form drug partnership

        • MD Anderson and Summit Medical Group launch partnership in New Jersey

        • Geisinger Health System sets higher accrual goals for DNA sequencing study

        • AbbVie acquires Stemcentrx and Rova-T drug candidate

        • AbbVie forms collaboration with argenx in immuno-oncology

        • Indiana University raises $1.2 million for research at tailgate gala

        Drugs and Targets
        • FDA grants approval to Cabometyx tablets in renal cell carcinoma

        • FDA grants Orphan Drug Designation to DelMar’s VAL-083 


        20160429 - Apr. 29, 2016
        ISSUE 16 – April 22, 2016PDF

        AACR 2016

        Biden Asks for Guidance in Leading Moonshot

        “There is more brain power in this room than exists in many countries,” said Vice President Joe Biden, addressing over 4,000 members of the American Association for Cancer Research, during a speech that turned personal at times, as he laid out several suggestions for accelerating progress.

        As head of the federal government’s cancer moonshot task force, the vice president listed recommendations he has received for reaching the initiative’s goal, not a cure, but completion of a decade’s worth of cancer research in five years. Recommendations include increasing research budgets across the federal government, making it easier to share data, removing paywalls around published research, and incentivizing verification of study results.

        “Toward that end, last year, the 2016 budget, and working with Congress, we were able to increase funding by $2 billion for the National Institutes of Health. The largest increase in a decade,” Biden said at the association’s annual meeting April 20 in New Orleans.


        Comparison with AstraZeneca Drug Hard to Ignore as ODAC Votes Down NSCLC Application from Clovis

        A phase III trial will be needed to determine approvability of the Clovis Oncology Inc. agent rociletinib for the treatment of non-small cell lung cancer, the FDA Oncologic Drugs Advisory Committee recommended.

        At a meeting April 12, ODAC in effect voted against granting an accelerated approval of rociletinib for the treatment of patients with mutant epidermal growth factor receptor non-small cell lung cancer who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test.

        Guest Editorial

        Thirty Years after Chernobyl: Lessons Learned

        By Robert Peter Gale

        April 26 marks the 30th anniversary of the Chernobyl nuclear power facility accident in the former Soviet Union. Soon after the accident, I received a call from the Soviet ambassador to the U.S. on behalf of Mikhail Gorbachev asking me to come immediately to Moscow.

        The world (but not Soviet citizens) had been following the spread of a radioactive cloud over Europe for several days and I offered the Soviet government access to advanced medical technologies I knew they lacked. I arrived to find about 205 of the most seriously-affected victims had been flown to Hospital 6 in Moscow connected to the Institute for Biophysics.

        AACR 2016 – In Brief

        Nancy Davidson Begins Term as AACR President; Weinberg Gets Lifetime Achievement Award

        Nancy Davidson was inaugurated as president of the American Association for Cancer Research for 2016-2017 at the association’s annual meeting in New Orleans.

        Davidson is the director of the University of Pittsburgh Cancer Institute. She also serves as associate vice chancellor for cancer research; the Hillman professor of oncology; a distinguished professor of medicine and pharmacology and chemical biology; and a professor in the Clinical and Translational Science Institute at the University of Pittsburgh School of Medicine. Her research focuses on clinical and translational breast cancer research and cancer biology and treatment.


        Academy of Arts and Sciences Elects 213 Members

        The American Academy of Arts and Sciences elected 213 new members, including some of the world’s most accomplished scholars, scientists, writers, artists, as well as civic, business, and philanthropic leaders.

        BSA Approves Plan to Expand SEER Infrastructure, Funding, and Research Support Capacity

        The NCI Board of Scientific Advisors approved a proposal to expand the infrastructure and capacity of the SEER program, including introducing registries designed specifically to support cancer research projects, an increase of the program’s overall budget, and moving toward a more advanced, uniform data management system.

        The new structure of the surveillance program would create core registries, selected through a competition of the U.S. central cancer registries, which would then collect the most comprehensive data to be used for SEER statistics and public use.


        Cell Therapy Production, Patient Accrual Suspended at Rosenberg’s Lab at NCI

        NIH has suspended the facilities that produce investigational compounds for an NCI laboratory engaged in cell therapy production and a National Institute of Mental Health facility producing positron emission tomography materials.

        As a result, no new new patients will be enrolled in affected trials until the issues are resolved, NIH said in a press release.

         Drugs and Targets
        • FDA grants approval to Gilotrif tablets in squamous cell lung cancer

        • University of Chicago and AbbVie to form five-year collaboration

        20160422 - Apr. 25, 2016
        ISSUE 15 – April 15, 2016PDF

        Parker Bets $250 Million on Immunotherapy

        A foundation established by Silicon Valley entrepreneur Sean Parker—founder of Napster and first president of Facebook—has committed $250 million to research in cancer immunotherapy.

        The newly founded Parker Institute for Cancer Immunotherapy brings together immunologists from Memorial Sloan Kettering Cancer Center, Stanford University, UCLA, UCSF, MD Anderson Cancer Center and the University of Pennsylvania.


        Conversation with The Cancer Letter

        Parker Mantra: Collaborate Like Hell

        The Cancer Letter invited Jedd Wolchok, associate attending physician and chief of the Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center, to describe the workings of the just-announced Parker Institute for Cancer Immunotherapy.

        Slamming the Door

        Part X – Silencing Faculty Voice

        In the fall of 2012, just before Al Gilman’s departure, MD Anderson officials cracked down on internal critics.

        On Sept. 26, 2012, Raphael Pollock, head of MD Anderson’s Division of Surgery, was summoned to the office of Thomas Burke, then the executive vice president and physician-in-chief, and was relieved of his duties.

        Pollock, who is Jewish, was fired on Yom Kippur, the Day of Atonement.

        Letter to the Editor

        Former MD Anderson Provost Reflects on “Brief, Painful Episode”

        By Raymond DuBois

        Over the past several weeks, The Cancer Letter has been running a series of articles that report on a past conflict between people at The University of Texas MD Anderson Cancer Center and Nobel Laureate Al Gilman, who led the scientific review teams of the then newly formed Cancer Prevention and Research Institute of Texas.

        At the time of the controversy, I was the founding provost and executive vice president at the MD Anderson Cancer Center, a position I enjoyed greatly. While I have no desire to revisit this brief, and somewhat painful episode in my academic career, I have been written into Goldberg’s Texas drama as an important bit player and therefore feel compelled to go on record and provide my view of the story.

        FDA Inspects Hospitals for Morcellation Harm;
        Congressman Draws VP Biden’s Attention to Issue

        FDA has conducted inspections of several hospitals—including Brigham & Women’s Hospital—based on allegations that physicians and administrators did not report patient harm and deaths resulting from power morcellators.

        In a March 29 letter to Rep. Mike Fitzpatrick (R-Pa.), the agency said it “takes these issues very seriously.”

        “In recent months, we have conducted inspections of hospitals highlighted in your letter, including Brigham & Women’s Hospital, Rochester General Hospital, and the University of Rochester Medical Center,” FDA officials wrote, responding to a Dec. 18, 2015, letter from Fitzpatrick to the agency’s Office of Criminal Investigations.

        Stand Up to Cancer Debuts Catalyst Research Program With Merck, BMS and Genentech

        Stand Up to Cancer announced Catalyst, a program that will use funding and materials from the pharmaceutical, biotechnology, diagnostic and medical devices industries to accelerate research on cancer prevention, detection and treatment.

        Founding collaborator Merck; and Bristol-Myers Squibb, and Genentech, a member of the Roche Group, will serve as charter supporters.

        In Brief
        • Jeffrey Sosman named director of melanoma program at Northwestern

        • Eric Dishman named director of NIH Precision Medicine Initiative Cohort Program

        • Ed Sauter named director of breast surgery at Hartford HealthCare Cancer Institute

        • Maya Martinez-Davis appointed global head of oncology franchise at Merck KGaA
        • Lynn Matrisian named chief research officer for the Pancreatic Cancer Action Network

        • Karin Jooss named chief scientific officer of Gritstone Oncology

        • USPSTF publishes B recommendation for low-dose aspirin regimen for primary prevention of colorectal cancer and cardiovascular disease

        • International Myeloma Foundation to fund large screening study in Iceland

        • MD Anderson Cancer Center dedicates new personalized medicine building

        • UC Davis and Novogene establish campus genomics center

        • University of Florida signs proton therapy contract with Ion Beam Applications
        Drugs and Targets
        • FDA grants accelerated approval to Venclexta in CLL

        • FDA approved Epi proColon blood screening test

        • FDA granted priority review for atezolizumab in NSCLC

        20160415 - Apr. 18, 2016
        ISSUE 14 – April 8, 2016PDF

        Jacks, Jaffee, Singer Named Co-Chairs of NCI’s Moonshot Blue Ribbon Panel

        NCI announced a panel of advisors to inform the scientific direction and goals of Vice President Joe Biden’s National Cancer Moonshot Initiative.

        The 28-member Blue Ribbon Panel, a committee of scientific experts, cancer leaders, and patient advocates, will serve as the working group of the National Cancer Advisory Board and provide scientific guidance from opinion leaders in the cancer community.


        FDA Allows Containment Bags for Power Morcellators; Paper Reports Leakage

        FDA granted permission to an Irish company to market the “PneumoLiner,” a first-of-its-kind containment system indicated for isolating and containing uterine tissue during a minimally invasive hysterectomy or myomectomy. The agency announced its action April 7.

        Gynecologists will soon be able to use the containment system—designed to prevent dissemination of potentially cancerous tissue—with specific models of power morcellators to conduct laparoscopic surgery in a limited population of women.

        ORIEN Partners with Pharma Companies to Develop Precision Medicines with Big Data

        The Oncology Research Information Exchange Network and M2Gen formed a bioinformatics collaboration with Celgene Corp.

        The partnership, announced April 7, is called the ORIEN Avatar Research Program. The initiative is managed by M2Gen and is designed to generate large amounts of genetic and clinical information on patients consenting to the Total Cancer Care Protocol, a standard operating protocol used by ORIEN member institutions.

        Caligiuri Named President-Elect of AACR

        Michael Caligiuri was named president-elect by the members of the American Association for Cancer Research. He will officially become president-elect at the AACR’s annual meeting in New Orleans, April 16-20, and will assume the presidency at the 2017 annual meeting.

        Caligiuri is director of The Ohio State University Comprehensive Cancer Center and CEO of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. He holds the John L. Marakas Nationwide Insurance Enterprise Foundation chair in cancer research and is a professor in The Ohio State University College of Medicine Departments of Molecular Virology, Immunology and Medical Genetics and Internal Medicine.

        In Brief
        • Timothy Eberlein elected Chairman of NCCN Board of Directors

        • Carbone Cancer Center joins NCCN as member institution

        • Larry Kwak wins 2013 Ho-Am Prize in Medicine

        • Joel Helmke named senior vice president of operations at City of Hope
        • Anne Jadwin honored by Sigma Theta Tau nursing honor society

        • Paul Bushdid joins Southern Research

        • Dana Farber and Ontario Institute for Cancer Research join OHSU and Intel’s data cloud program

        • RareCyte signs CRADA with NCI

        • IBM launches Watson center in Milan, Italy

        • Schulman IRB selected for Cancer MoonShot 2020 program
        Drugs and Targets
        • EU approves two-dose schedule for Gardasil 9

        • Halaven receives positive opinion from CHMP in liposarcomas

        • OncoBEAM RAS CRC test receives CE mark

        • University of Chicago and Evelo Biosciences enters licensing agreement
        20160408 - Apr. 4, 2016
        ISSUE 13 – April 1, 2016PDF

        NCI Makes Plans for Moonshot Dollars

        At a meeting of the NCI Board of Scientific Advisors March 29, NCI officials had good news to report:

        • The appropriations are increasing, with bipartisan support to boot.

        • The White House “moonshot” initiative on cancer is bringing new money and new urgency to the institute’s work.

        The cancer program has seen many aggressive mandates and has made many big promises, and it’s worthwhile to remember this current initiative is being launched by an administration that is concluding its term.


        AVEO Execs Face Fraud Charges from SEC;

        Company to Pay $4 Million to Settle

        The Securities and Exchange Commission March 29 announced fraud charges against AVEO Pharmaceuticals Inc., a biotechnology company, and three of its former executives.

        SEC said the company agreed to pay a $4 million penalty to settle the charges without admitting or denying the allegations.

        The agency said it is continuing to pursue its case against three of AVEO’s former officers: CEO Tuan Ha-Ngoc, Chief Financial Officer David Johnston, and Chief Medical Officer William Slichenmyer.

        Schools of Public Health: Cancer Moonshot Undervalues Prevention

        Over 70 deans and directors of public health programs and institutes signed a letter March 21 asking the White House for to prioritize federal investments in public health and cancer prevention.

        The letter, addressed to Vice President Joe Biden, urges the administration to “pay careful attention to the balance between treatment and prevention-related investments.”

        In Brief
        • Dinah Singer and Warren Kibbe named acting NCI deputy directors

        • Peter Paul Yu named physician-in-chief at Hartford HealthCare Cancer Institute

        • Greg Simon named executive director of national cancer moonshot initiative

        • Johns Hopkins launches Bloomberg-Kimmel Institute for Cancer Immunotherapy
        • Hyundai Hope on Wheels announces $1 million in pediatric research grants

        • MD Anderson and TESARO form immuno-oncology collaboration

        Drugs and Targets
        • FDA publishes draft guidance on biosimilar product labeling

        • FDA approves Defitelio for veno-occlusive disease following transplantation

        • FDA grants Orphan Drug Designation to Iomab-B


        20160401 - Apr. 1, 2016
        March 2016PDF




        Vyxeos Injection Improves Overall Survival In Phase III Acute Myeloid Leukemia Trial

        A phase III trial of Vyxeos Liposome for Injection demonstrated statistically significant improvements in overall survival in patients with high-risk secondary acute myeloid leukemia.

        The median overall survival for patients treated with Vyxeos (cytarabine: daunorubicin) in the study was 9.56 months compared to 5.95 months for patients receiving the standard of care regimen of cytarabine and daunorubicin known as 7+3.

        The hazard ratio was 0.69 (p=0.005) which represents a 31 percent reduction in the risk of death versus 7+3, according to Celator Pharmaceuticals Inc., the drug’s sponsor, which plans to submit the data for presentation at the 2016 annual meeting of the American Society of Clinical Oncology.

         Non-Small Cell Lung Cancer

        Atezolizumab Immunotherapy Boosts OS Compared to Docetaxel in Phase II Trial

        Patients with advanced metastatic lung cancer treated with atezolizumab, a targeted immunotherapy drug, lived significantly longer and with fewer side effects than those who received docetaxel chemotherapy, according to a study published in The Lancet.

        “The results of this study demonstrate that the use of atezolizumab, a monoclonal antibody, improves the survival rate of a majority of lung cancer patients who have progressive cancer when used after first-line chemotherapy,”


         Drugs and Targets

        FDA Approves Imbruvica in First-Line CLL

        FDA approved Imbruvica (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukemia.

        The approval is based on data from the randomized, multi-center, open-label phase III RESONATE-2 trial, which evaluated the use of Imbruvica versus chlorambucil in 269 treatment-naïve patients with CLL or small lymphocytic lymphoma aged 65 years or older. The data were previously presented at the annual meeting of the American Society of Hematology in December 2015 and also published in The New England Journal of Medicine.


        Ovarian Cancer

        Study: Reolysin-Paclitaxel Combination Demonstrates Higher Response Than Paclitaxel Therapy Alone


        Tocagen Expands Phase II/III Trial, Begins Enrolling in Canada


        Two Phase III Anamorelin Trials Show Improved Lean Body Mass

         NCI CTEP-Approved Trials for the Month of March
        20160331 - Mar. 31, 2016
        ISSUE 12 – MARCH 25, 2016PDF

        Clifford Hudis Named CEO of ASCO

        Clifford Hudis was named CEO of the American Society of Clinical Oncology.

        Hudis, who served as ASCO president in 2013 and 2014, is chief of Breast Medicine Service as well as vice president for government relations and chief advocacy officer at Memorial Sloan Kettering Cancer Center.

        Hudis, 56, will start the job at the society’s headquarters in Alexandria, Va., June 27. He will succeed Allen Lichter, who is retiring after having held that job for ten years.


        NEJM Editors: There Will Be No Clarification For Disputed Power Morcellation Story

        The New England Journal of Medicine said it stands by the story that has triggered investigations of a potential breach of patient confidentiality.

        In a paper that criticized FDA’s regulatory actions that effectively ended power morcellation in gynecology, Lisa Rosenbaum, an NEJM national correspondent, made a statement that some readers interpreted as suggesting that she had access to confidential patient information (The Cancer Letter, March 18).

        Rosenbaum is a cardiologist at Brigham & Women’s Hospital, the institution where Amy Reed—a patient who brought national attention to the harm associated with the procedure—underwent her ill-fated hysterectomy. 

        Slamming the Door

        Part IX – “Furnituregate”

        I first heard something about a red sofa that cost an impressive amount of money soon after I started to cover the controversy at the Cancer Prevention and Research Institute of Texas.

        The sofa, I was told, was to be purchased with MD Anderson funds for the office of Lynda Chin. I wanted to look into it, but I want to look into many things, and some take precedence over others. This seemed to be fun, but it was undeniably trivial.

        The sofa in question was intended for the same entity CPRIT was being asked to fund. Had I been able to get it through my thick skull that the furniture was a part of the same story that was causing the ungluing of CPRIT, I would have filed my freedom of information requests sooner.

        NCCN Launches Evidence Blocks as Part of its Guidelines

        The National Comprehensive Cancer Network launched its value tool, NCCN Evidence Blocks, which will be presented at its annual conference, March 31 to April 2.

        NCCN has published two additional resources since its 2015 meeting: the NCCN Framework and the NCCN Quick Guide Series for patients.

        In Brief
        • Maha Hussain joins Northwestern University Lurie Cancer Center

        • Jean-Yves Douillard appointed chief medical officer of ESMO

        • Karmanos promotes five scientific staff members

        • Jennifer Pietenpol receives award from T.J. Martell Foundation
        • Pediatric Oncologist Dennis Hughes pleads guilty to collecting child pornography

        • American Cancer Society receives $1.58 million grant from The Merck Foundation

        • MD Anderson submits plan to comply with Texas “Campus Carry” gun law 

        • The Cancer Letter’s coverage of power morcellation named a finalist in the 2015 Best in Business Awards for Outstanding Business Journalism
        Drugs and Targets
        • FDA Approves Roche Hepatits C RNA Test

        • UPenn and Genisphere form photodynamic therapy collaboration


        20160325 - Mar. 25, 2016
        ISSUE 11 – MARCH 18, 2016PDF

        Brigham Doc’s NEJM Paper Decries Morcellation’s Demise—Did She Get Confidential Patient Information?

        Clearly, Lisa Rosenbaum wanted to trigger a heated discussion—but not of the sort she ended up with.

        Rosenbaum, a national correspondent at the New England Journal of Medicine, focused on the demise of power morcellation, a once widely used gynecological procedure, which in some cases ended up disseminating undetected uterine sarcomas.

        In a paper published in the March 10 issue of the journal and titled “N-of-1 Policymaking—Tragedy, Trade-offs, and the Demise of Morcellation,” Rosenbaum alleges that Amy Reed, a high-profile opponent of power morcellation, had stage IV cancer before her hysterectomy.

        Capitol Hill

        Senate Bill Gives FDA More Control Over Its Hiring, Salaries and Structure

        The FDA and NIH Workforce Authorities Modernization Act was introduced in the Senate by Republican and Democratic leaders of the health committee. The bill aims to help FDA and NIH “attract top talent during this exciting time in science.”

        The bill, introduced by Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.), looks to improve coordination within and between FDA medical product centers and allow the FDA to update its structure, as well as make it easier for the agency to hire; improve access to scientific meetings for federal employees; and streamline processes for NIH research information collection.

        Slamming the Door

        Part VIII – A Conversation with DePinho

        The $18 million never made it from Austin to Houston.

        MD Anderson’s initial stance was to deflect all CPRIT-related questions to CPRIT, but this didn’t make the controversy go away. So, the cancer center suggested that the grant undergo scientific review, as well as commercial.

        Recently, I asked Dan Fontaine, MD Anderson’s executive chief of staff why the money never changed hands.

        Bunn Wins ASCO Karnofsky Award; Kaelin to Receive Science of Oncology Award

        The American Society of Clinical Oncology announced the winners of its highest honors, the Special Awards, to be presented during the 2016 ASCO Annual Meeting in June.

        “The exceptional accomplishments of each of our awardees reflect their exemplary dedication to furthering cancer research and serving as a beacon of hope to the cancer community,” said Peter Paul Yu, immediate past president of ASCO and chair of the Special Awards Selection Committee. “It is our honor to recognize their enduring contributions with ASCO’s most prestigious awards.”


        UNMC Radiologist Glenn Dalrymple, 81;

        and MSKCC Researcher Robert Golbey, 93

        Glenn Dalrymple, a radiology professor at the University of Nebraska Medical Center from 1990 to 1996, died March 9 in Omaha after a long battle with colon cancer. He was 81.


        In Brief
        • Itai Yanai to Lead New Institute at NYU Langone

        • Debra Patt named Editor-in-Chief of JCO Clinical Cancer Informatics 

        • Jennie Crews elected president of Association of Community Cancer Centers

        • Charles Serhan receives Ross Prize from Feinstein Institute for Medical Research
        • American Society of Clinical Oncology publishes State of Cancer Care 2016

        • V Foundation and WWE announce research funding partnership 

        • Providence Health & Services and Institute for Systems Biology 

        Drugs and Targets
        • Gilead Halts 6 Zydelig Trials As FDA, EMA Warn of Deaths From Respiratory Infections

        • FDA Grants Orphan Designation to VAL-083

        • FDA Grants Priority Review to Atezolizumab


        20160318 - Mar. 18, 2016
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