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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

 

 

Leukemia

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,”

Also:

 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.

Also:

Ovarian Cancer

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

 Glioblastoma

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

 Cachexia

Two Phase III Anamorelin Trials Show Improved Lean Body Mass

 NCI CTEP-Approved Trials for the Month of March
20160331 - Mar. 31, 2016