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ISSUE 17 – MAY 1, 2015PDF

Thumbs Up on Amgen’s T-VEC to Treat Melanoma; Is it Local Therapy for Systemic Disease?

An FDA advisory committee April 29 recommended approval of a metastatic melanoma treatment based on an attenuated Herpes Simplex Virus-1.

In a joint meeting, the agency’s Oncologic Drugs Advisory Committee and its Cellular, Tissue, and Gene Therapies Advisory Committee voted 22 to 1 to recommend full approval for talimogene laherparepvec, sponsored by Amgen Inc.

At the contentious all-day meeting, which ran twice as long as a standard session of ODAC, the unusually large group of advisors summoned by the FDA didn’t get the opportunity to clearly identify the group of patients who stand to benefit from the agent, also called T-VEC, or specify the agent’s place in a sequence of melanoma treatments.

NIH Slated to Receive $10 Billion Increase In Second 21st Century Cures Draft Bill

The House Committee on Energy and Commerce published the second “discussion draft” for a comprehensive bipartisan initiative aimed at streamlining development of drugs and medical devices.

The proposed legislation, called “21st Century Cures,” was launched April 30, 2014, and is led by Rep. Fred Upton (R-Mich.), chairman of the committee, and Rep. Diana DeGette (D-Colo.), chief deputy whip.

In addition to boosting NIH funding by $10 billion over five years and establishing a clinical trial data system for federally funded trials, the discussion draft includes provisions for developing the next line of antibiotics.

Institute of Medicine to Become National Academy of Medicine

The membership of the National Academy of Sciences voted April 28 at its 152nd annual meeting to change the name of the Institute of Medicine to the National Academy of Medicine, effective July 1.

The National Academy of Medicine will continue to be an honorific society and will inherit the more than 1,900 current elected members and foreign associates of the IOM.

 

Letter to the Editor

MD Anderson Administration Behaves as a “Financially Privileged Elitist Group”

To the Editor:

Congratulations on your outstanding article entitled “MD Anderson Execs Get Big Raises In the Midst of Faculty Morale Woes.” As a 35-year faculty member of the MD Anderson Cancer Center, now retired, I am deeply disturbed at the endangered reputation of one of the greatest institutions of its kind in the world. Every other month seems to bring some embarrassing new revelation at the hands of the current leadership.

 

An Appreciation

Mike Katz, 61, Advocate, Educator

By Michael D. Scott

The cancer field is filled with advocates—advocates for research into specific forms of malignancy, advocates for access to care for patients with limited resources, advocates for pediatric cancers—you name it. Many of these people are motivated, passionate, determined, and successful in moving their specific agendas forward in the interests of patients, clinicians, researchers, and others.

In Brief

  • Margaret Kripke to retire as CPRIT chief scientist

  • CPRIT to award two grants

  • ASCO Conquer Cancer Foundation names annual award winners

  • Karmanos Cancer Institute raises $2.8 million at annual dinner
  • IU Simon Cancer Center raises $720,000 at CHUCKSTRONG tailgate gala
  • Dana-Farber, Harvard School of Public Health, and Irish Cancer Society form collaboration
  • St. Jude forms affiliate with Novant Health
  • Geisinger Health System opens precision medicine center
Drugs and Targets

  • FDA grants orphan designation to Reolysin in malignant glioma

  • Paclical receives market authorization in Russian Federation

  • Celgene International II Sarl forms collaboration with MedImmune

20150501 - May. 1, 2015
April 2015PDF

 

Melanoma

Keytruda Meets PFS, OS Endpoints in Phase III Advanced Melanoma Trial

A phase III study investigating Keytruda patients with advanced melanoma met two primary endpoints, demonstrating improvements in progression-free survival and overall survival compared to Yervoy. The study’s independent data monitoring committee recommended stopping the trial early.

In the trial, named KEYNOTE-006, Keytruda (pembrolizumab) improved PFS by 42 percent and extended overall survival by 34 percent compared to Yervoy (ipilimumab).

Investigators from 16 countries enrolled 834 patients with metastatic melanoma in the clinical trial, and patients were randomly assigned to Keytruda and Yervoy. The study was published online in the New England Journal of Medicine, and was presented at the annual meeting of the American Association for Cancer Research. The trial was sponsored by Merck.

 

Prostate Cancer

Three Xtandi Trials Show Positive Results In Castration-Resistant Prostate Cancer

Astellas Pharma Inc. and Medivation Inc. presented an updated overall survival analysis from the placebo-controlled phase III trial of Xtandi in chemotherapy-naive metastatic CRPC.

The companies also published data from two separate phase II head-to-head studies, named STRIVE and TERRAIN, comparing Xtandi (enzalutamide) to Casodex (bicalutamide).

The phase III trial, named PREVAIL, was a randomized, double-blind trial that enrolled 1,717 patients at sites in the U.S., Canada, Europe, Australia, Russia, Israel and Asia, including Japan.

 

Drugs and Targets

FDA Updates Zytiga Label To Include Chemotherapy-Naive Metastatic CRPC Data

FDA approved a label update for Zytiga (abiraterone acetate) plus prednisone to include overall survival results in chemotherapy-naive men with metastatic castration-resistant prostate cancer.

The update was based on the final analysis of the phase III, randomized, double-blind, placebo-controlled COU-AA-302 study, which showed that Zytiga plus prednisone significantly prolonged median overall survival, compared to placebo plus prednisone. 

 

Breast Cancer

Ongoing Phase II Trial Shows Correlation Between Immune Response and Recurrence

 

Lymphoma

Circulating Tumor Cells Can Be Used to Detect DLBCL Recurrence, Researchers Say

 NCI CTEP-Approved Trials for the Month of April 
  
20150430 - Apr. 30, 2015
ISSUE 16 – APRIL 24, 2015PDF

Foes Immediately Vow to Nullify Task Force Guideline on Mammography for Women 40-49

The breast cancer screening recommendations proposed by the U.S. Preventive Services Task Force earlier this week are basically unchanged from the 2009 version.

WARNING: a reader’s yawn at this juncture would be misplaced.

The recommendations proposed and put in place five years ago were so politically radioactive that they could have jeopardized the passage of the Affordable Care Act.

Indeed, the ACA specifically excluded the task force’s 2009 recommendation on mammography.

Immediately after the 2009 draft recommendation was published, then HHS Secretary Kathleen Sebelius in effect urged women between 40 and 49 to disregard the panel’s evidence-based guideline. An amendment to the ACA, called the “Women’s Preventive Health Amendment,” finished the job of invalidating the guideline. (This made the ACA politically viable.)


Mammography: When, Really, is the Right Time? And at What Cost? 

As a firestorm ignites around the U.S. Preventive Service Task Force draft recommendation on mammography, researchers and advocates are grappling with the questions at the heart of the controversy:

• Should women start screening for breast cancer at age 40 or 50?
• What is the prevalence of false-positives and overdiagnosis in these age groups?
• What are the costs of harm?

The USPSTF draft recommendation, published April 20, comes on the heels of a controversial study which estimates that the

U.S. spends $4 billion a year on unnecessary mammograms for women between the ages of 40 to 59.

Mandl: Costs of Harm from Mammography Must Be Balanced Against Benefits

The U.S. spends $4 billion on unnecessary mammograms each year, according to a study published in the April issue of Health Affairs.

Titled “National Expenditure for False-Positive Mammograms and Breast Cancer Overdiagnoses Estimated at $4 Billion a Year,” the study, by Kenneth Mandl and Mei-Sing Ong, uses expenditure data from a major U.S. health care insurer for 702,154 women in 2011 to 2013.

Of the $4 billion, $2.8 billion is attributed to false-positive mammograms, and $1.2 billion to breast cancer overdiagnosis. The study measures the rate of false positives at 11 percent and overdiagnosis at 22 percent.

Wender: Mammography Guidelines Should Balance Benefits and Risks, Not Costs

“Let me be really clear: I don’t think that article should have or will have any impact on the [US Preventive Services Task Force], and it will not have any impact on [the American Cancer Society] guidelines, either,” Wender said.

 

Four Decades of Mammography Wars

The latest draft guideline by the U.S. Preventive Services Task Force is part of nearly a four-decade war over the appropriateness of screening women between the ages of 40 and 49.

In this war, Congress usually intervened, claiming that “common sense” dictates that mammography is efficacious in younger women. This war has often engulfed NCI.

This timeline appeared in part in the Nov. 20, 2009, issue of The Cancer Letter.

AACR Annual Meeting 2015

  • Jose Baselga becomes president of AACR

  • Two Stand Up To Cancer Dream Teams launched in ovarian and lung cancer

  • Multiple award winners named

The Cancer Letter Receives Sigma Delta Chi Award

The Cancer Letter won a 2014 Sigma Delta Chi Award for Public Service in Journalism from the Society of Professional Journalists on April 23.

The Sigma Delta Chi Awards is a national competition dating back to 1932. The award recognizes Matthew Ong’s series “Power Morcellation: A Hazardous Practice” as the winner in the Newsletter category.

“This award recognizes a newsletter that renders outstanding public services through extensive coverage of an issue facing the community it serves,” the description reads.

Ong’s series, which includes an interview documentary, can be found here.

20150424 - Apr. 24, 2015