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ISSUE 45 – DEC. 11, 2015PDF



Core Grants of Newer, Smaller Centers

Slated to Get Immediate Funding Boost

NCI is implementing a less draconian formula for increasing the core grants of newer cancer centers.

The plan, which was unveiled at the Dec. 1 joint meeting of the Board of Scientific Advisors and the National Cancer Advisory Board, seeks to correct an acknowledged inequity: by virtue of being in the NCI program longer, more established cancer centers had more incremental increases, thus amassing larger core grants.

In a unanimous vote, BSA asked for some refinements to the plan, but seemed to be fine with its main features.

An earlier version of the plan called for fundamental changes in the funding formula, which—according to NCI modeling—would have reduced the core grants of some of the older, larger cancer centers and gave these funds to the newer centers.

Capitol Hill

NIH Looks For $1-2 Billion Raise in FY 2016

As Congress Approaches Another Deadline

NIH is slated to receive a $2 billion increase under the Senate appropriations bill, but only $1.1 billion under the House plan for the current 2016 fiscal year.

The Senate version would bring NIH finding up to $32 billion, with NCI receiving $5.204 billion. The House version would total just above $31 billion for NIH, including $5.081 billion for NCI.

Both chambers of Congress are setting aside $200 million for the Precision Medicine Initiative, which would include $70 million for NCI.

Guest Editorial

The Academic Difference

By George J. Weiner

Academic cancer centers have a major and unique role to play in enhancing cancer research, clinical care and education. This role will increase in value as our understanding of the complexity of cancer grows and is applied to care of patients.

Academic cancer centers leverage synergies among these various missions, with the result being a positive impact on patient health and the economy at the local, regional and national levels. Accelerating progress in cancer medicine is dependent on the success of academic cancer centers and development of new models of collaboration between academic cancer centers and community oncology.

ACS and ASCO Jointly Publish Breast Cancer Survivorship Guideline for Primary Physicians

The American Society for Clinical Oncology and the American Cancer Society published a joint guideline for primary care physicians on managing the long-term care of breast cancer survivors, recommending regular surveillance for recurrence, but not performing laboratory or imaging tests in patients not displaying symptoms.

In Brief

  • Carlos Rodriguez-Galindo to lead St. Jude’s international outreach
  • Daniel Simon named president of UH Case Medical Center
  • Terrill Jordan named president and CEO of Regional Cancer Care Associates
  • Gustave Roussy institute recruiting young doctors
  • Baylor to collaborate with Biocept on blood-based cancer tests
Drugs and Targets

  • FDA grants accelerated approval to Alecensa for ALK-positive NSCLC patients
  • FDA approves Vistogard for emergency treatment of certain chemotherapy overdoses
  • FDA clears cooling cap for preventing hair loss during chemotherapy
  • EMA grants orphan designation ot Debio 1143
  • Amgen submits expanded application for Kyprolis in the EU
  • AstraZeneca and Voluntis to test digital support service in ovarian cancer trials
  • Eli Lilly and Merck to collaborate on abemaciclib-Keytruda phase I trial
20151211 - Dec. 11, 2015
ISSUE 44 – DEC. 4, 2015PDF



Mary Pazdur, 63, Dies of Cancer;

What Her Husband Has Learned

The job interview wouldn’t last more than 15 minutes, Richard Pazdur believed.

So, on a June morning in 1999, his wife Mary settled down to wait at a restaurant near the FDA buildings alongside Rockville Pike.

The restaurant turned out to be Hooters, and Mary ended up spending three hours at the joint known for all-you-can-eat chicken wings served by scantily clad waitresses known as Hooters Girls.

“How much Hooters coffee can you drink?” Mary said frequently, retelling the story of her introduction to FDA, Washington and cancer politics.

Rick’s Search for Meaning

On Nov. 17, Richard Pazdur, director at the FDA Office of Hematology and Oncology Products, spoke about the role that has been thrust upon him: that of a “regulator/advocate.”

“What we’re seeing now is not a patient voice but a patient cry—wanting to have their position heard,” said Pazdur, speaking at a Washington conference sponsored by Friends of Cancer Research.

NCI Director’s Report

Lowy: Higher RPG Success Rates in 2015;

Continuing Resolutions Will Slow Progress

NCI awarded about 635 R01s in 2015, up from 629 in 2014, said NCI Acting Director Doug Lowy at a recent joint meeting of the National Cancer Advisory Board and the NCI Board of Scientific Advisors.

The number of R01 awards fell short of pre-sequestration levels, but there has been a substantial increase in R21 applications—from 225 in 2012 to about 355 in 2015.

Funding Opportunity

Debbie’s Dream Foundation Offering $200,000 in Grants

Debbie’s Dream Foundation: Curing Stomach Cancer launched two research grants totaling $200,000 for the 2015-2016 grant cycle. A Career Development Award for $150,000 and a Young Fellowship Grant for $50,000 are being offered.

In Brief

  • Jennifer Nam Choi named chief of oncodermatology at Northwestern Memorial
  • Robert Hauser named vice president of clinical analytics at Cancer Treatment Centers of America
  • Mia Levy to be director of health information and strategy at Vanderbilt-Ingram Cancer Center
  • City of Hope announces three personnel changes
  • David Flockhart, board member of the Personalized Medicine Coalition, died Nov. 26
  • Fox Chase-Temple Health form collaboration with Accutest Research Labs in India
  • Manipal Hospitals to use IBM Watson technology
  • ASTRO publishes template for long-term survivor plans
  • West Cancer Center opens its East Campus
  • National Health Care Anti-Fraud Association names it’s 2015 Investigation of the Year
Drugs and Targets

  • FDA approves Opdivo in renal cell carcinoma
  • European Commission grants marketing authorization for Kyprolis in multiple myeloma
  • EMA accepts anamorelin application for review
  • MD Anderson and Boehringer Ingleheim announce collaboration
  • Morphotek and Targeted Alpha Therapy Group to collaborate in ovarian cancer
  • Roche and Upsher-Smith Laboratories to develop VAP-1 inhibitor
  • Caris Life Sciences and Syapse to collaborate on genomic information
20151204 - Dec. 4, 2015

NCI CTEP-Approved Studies for the Month of November

 

The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month. For further information, contact the principal investigator listed.

 

Phase I

CITN-12: Phase I Study of MK-3475 (Pembrolizumab) in Patients with Human Immunodeficiency Virus (HIV) and Relapsed/Refractory or Disseminated Malignant Neoplasm. Cancer Immunotherapy Trials Network; Uldrick, Thomas S. (301) 402-6296

 

PBTC-047: Phase I Trial of Panobinostat in Children with Diffuse Intrinsic Pontine Glioma. Pediatric Brain Tumor Consortium; Monje, Michelle. (650) 736-0885

 

Phase II

ADVL1522: A Phase 2 Study of IMGN901 (Lorvotuzumab Mertansine; IND#: 126953, NSC#: 783609) in Children with Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor (MPNST) and Synovial Sarcoma. Children’s Oncology Group; Geller, James Ian. (513) 636-6312 X 6312

 

AOST1321: Phase 2 Study of Denosumab (IND# 127430, NSC# 744010), a RANK Ligand Antibody, for Recurrent or Refractory Osteosarcoma. Children’s Oncology Group; Janeway, Katherine Anne. (617) 632-4994

 

AOST1421: A Phase II Study of Human-Mouse Chimeric Anti-Disialoganglioside Monoclonal Antibody ch14.18 (Dinutuximab, NSC# 764038, IND# 4308) in Combination with Sargramostim (GM-CSF) in Patients with Recurrent Osteosarcoma. Children’s Oncology Group; Hingorani, Pooja. (602) 546-0920

 

Other Phases

AALL14B7-Q: Screening Low-Hypodiploid B-ALL for Pro-B Phenotypes. Children’s Oncology Group; Carlson, Christopher. (206) 667-7034

 

AAML15B5-Q: The Role of Id1 in Leukemogenesis. Children’s Oncology Group; Wang, Lan. (305) 243-8920

 

AEWS15B1-Q: Development of Specific and Reversible LSD1 Inhibitors for Ewing’s Sarcoma. Children’s Oncology Group; Lessnick, Stephen L. (415) 476-3831

 

AEWS15B1-Q: Development of Specific and Reversible LSD1 Inhibitors for Ewing’s Sarcoma. Children’s Oncology Group; Lessnick, Stephen L. (415) 476-3831

 

ANHL14B1-Q: Genomic Analysis of Pediatric Anaplastic Large Cell Lymphoma ALCL. Children’s Oncology Group; Leventaki, Vasiliki. (901) 595 7531

 

APEC14B1: The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study. Children’s Oncology Group; Adamson, Peter C. (215) 590-6359

 

E1608T2: Inherited Markers as Predictors of Adverse Events and Survival Among Melanoma Patients Treated with Ipilimumab. ECOG-ACRIN Cancer Research Group; Nathanson, Katherine Leah. (215) 573-9840

 

S1417CD: Implementation of a Prospective Financial Impact Assessment Tool in Patients with Metastatic Colorectal Cancer. SWOG; Shankaran, Veena (206) 288-7456

20151201 - Dec. 1, 2015