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December 2014PDF

 Drugs and Targets

FDA Grants Approvals to Lynparza, Blincyto, Xgeva, Gardasil 9 and Cyramza

FDA approved Lynparza (olaparib) capsules as monotherapy for the treatment of patients with deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. FDA also approved a molecular companion diagnostic.

The approval of Lynparza, sponsored by AstraZeneca Pharmaceuticals LP, is based on objective response rate from the international single-arm trial in patients with deleterious or suspected deleterious gBRCAm advanced cancers. The trial enrolled 137 patients with measurable, gBRCAm-associated ovarian cancer treated with three or more prior lines of chemotherapy.

 Leukemia

Tasigna Shows High Response, PFS Benefit Compared to Gleevec in Phase III CML Study

Six-year results from the randomized phase III ENESTnd study continued to show higher rates of early, deep and sustained molecular responses when using Tasigna (nilotinib) compared to Gleevec (imatinib mesylate) in newly-diagnosed Philadelphia chromosome-positive chronic myeloid leukemia. 

The data also demonstrated a reduced risk of progression compared to Gleevec. The update was presented at the annual meeting of the American Society of Hematology in San Francisco.

The difference in the rates of MR4.5 showed continued improvement for both Tasigna 300 mg and 400 mg twice-daily arms compared to Gleevec (MR4.5: 6-10 percent difference by one year, 22-23 percent difference by six years). MR4.5 represents an extremely low level of detectable BCR-ABL protein, the cause of Ph+ CML (measured in the blood at 0.0032 percent or less on a standardized international scale). 

Also:

 Breast Cancer

Ovarian Suppression Treatment Plus Tamoxifen Can Lower Recurrence Risk

Premenopausal women who received ovarian suppression treatment along with tamoxifen had a lower risk of breast cancer recurrence, according to data from a clinical trial sponsored and supported by NCI.

The study showed that suppressing ovarian function reduced breast cancer recurrence in premenopausal women receiving the drug tamoxifen after surgery for early-stage breast cancer. 

The phase III trial, SOFT (Suppression of Ovarian Function Trial), used either monthly injections of the drug triptorelin, surgical removal of both ovaries, or radiation of the ovaries as methods of ovarian suppression in women with hormone receptor-positive breast cancer. 

 Lymphoma
Phase II Imbruvica Trial Shows 47% of MCL Patients Alive at 27-Month Follow-up
 Gastric Cancer
Amgen Cancels Phase III Trials of Rilotumumab
 NCI CTEP-Approved Trials for the Month of December
20150102 - Jan. 2, 2015
ISSUE 47 – DEC. 19, 2014PDF

Congress Plans to Accelerate Development of Drugs, Devices

The House Committee on Energy and Commerce is spearheading legislation aimed streamlining development of drugs and medical devices. 

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

Research Advocates Prepare to Face Republican-led Congress

The 113th Congress staggered through its final spending bill, approving $1.1 trillion in a massive “cromnibus” Dec. 13, keeping most of the federal government funded through September 2015, and locking in a half-percent increase for NIH and NCI in FY2015.

Biomedical research advocates bemoaned the modest increase in funding—$150 million for NIH and $27 million for NCI—and questioned Congress’s commitment to scientific progress. 

Half-Percent NIH, NCI Budget Raise Is Not Enough, Advocates Say

The Cancer Letter asked leaders of science and cancer advocacy groups to comment on the half-percent increases in federal funding for NIH and NCI in fiscal 2015, and on the prospects of science funding when Republicans take control of Congress in January. 

Conversation with The Cancer Letter
Is Republican Control Better Than Two-Party Stalemate?

As Congress goes into recess and Democrats relinquish their eight-year control of the Senate, advocates for biomedical research are rethinking their approaches to a political reality not observed in nearly a decade: a Republican-controlled Congress.

Jennifer Zeitzer, director of legislative relations at the Federation of American Societies for Experimental Biology, a coalition that represents 27 scientific societies and over 120,000 researchers worldwide, says she is optimistic about prospects for science funding in the 114th Congress. 

The reason: both sides have learned that stalemates benefit no one.

ACS President & COO Resigns Unexpectedly; Was Seen as Contender for CEO Position

Gregory Bontrager resigned from his position as chief operating officer and president of the American Cancer Society.

His resignation was announced in an email from ACS Chief Executive Officer John Seffrin Dec. 18. No reason for the departure was cited. 

Bontrager, who became the COO in 2007 and president in 2013, was, in effect, the society’s second-most-powerful official, and one of the engineers of its current move to a centralized structure.

The Cancer Letter is taking a Holiday Break. 

The next issue will be published on Jan. 9, 2015.

ODAC To Advise FDA on First Biosimilars Application Jan. 7

The FDA Oncologic Drugs Advisory Committee will meet Jan. 7, 2015, to discuss a biologics license application for a proposed biosimilar to Amgen Inc.’s Neupogen (filgrastim).

The biosimilar application, submitted by Sandoz Inc., will be the first such application to be filed and discussed by an FDA advisory committee. 

NCI Advisory Board Approves Three Concepts

At a meeting Dec. 2, the NCI Board of Scientific Advisors approved three concepts during a joint meeting with the National Cancer Advisory Board.

Editorial

A Record-Breaking Year for The Cancer Letter

2014 was a transformative year for The Cancer Letter. 

• We launched a new website that makes our content possible to read online without downloading PDF files. 

• We made the website “responsive,” enabling it to adapt to all screen sizes, including smartphones and tablets. Now, about a third of our readers use these devices. An app will be available shortly.

Regulatory Approvals

  • FDA expanded the approved use of Cyramza to include metastatic NSCLC
  • FDA approves Somatuline Depot Injection (lanreotide) for metastatic GEP-NETs
  • Lynparza (olaparib) and companion diagnostic approved in gBRCAm advanced ovarian cancer
  • 510(k) clearance granted to Narrow Band Imaging for bladder cancer patient
  • FDA clears Advaxis immunotherapy phase I/II trial IND application
  • Genentech submits new drug application for cobimetinibn
In Brief

  • Fabien Calvo named chief scientific officer of Cancer Core Europe

  • OSUCCC – James moves into new cancer hospital

  • MD Anderson and UnitedHealthcare launch bundled payment program

  • Ohio State University names 2014 James Hope Award winners

  • Washington University at St. Louis genome center receives $25 million pledge

  • George Washington University Cancer Institute receives $150,000 from Center for Advancing Health

  • Northwestern University’s Lurie Comprehensive Cancer Center enters research agreement with NeoGenomics Inc.

  • Oregon Health & Science University and FEI expand Living Lab for Cell Biology agreement

  • Cancer Treatment Centers of America select WIRB-Copernicus Group to help expand its clinical research program

20141219 - Dec. 19, 2014
ISSUE 46 – DEC. 12, 2014PDF

Is Everyone in Academic Medicine Unhappy?
Or is it Just MD Anderson?

Faculty members at MD Anderson Cancer Center are arguably the most intensely watched cohort in academic medicine. Their angst has been measured four times by three administrative entities over two years.

Now, the institution’s president, Ronald DePinho, is under a mandate from his bosses to improve faculty morale.

Are these folks an anomaly, or is everyone in academic medicine unhappy these days?

There is a place to obtain comparison data: the Faculty Forward Engagement Survey conducted by the Association of American Medical Colleges. 

Senate Debates $1.1 Trillion “Cromnibus” Bill That Includes a $150 Million Increase for NIH

Early Friday morning, President Barack Obama signed a two-day funding resolution averting a government shutdown and giving the Senate time to debate a $1.1 trillion funding package passed by the House of Representatives late Thursday night.

The year-long “cromnibus” bill—a Washington-speak portmanteau of continuing resolution and omnibus—passed by a 219-to-206 vote three hours before government funding expired.

Daniel Hayes Elected President of ASCO

Daniel Hayes was elected president of the American Society of Clinical Oncology. The three-year appointment begins with Hayes becoming president-elect on June 1, 2015. He will serve as president from June 1, 2016, to May 31, 2017, and will serve as immediate past-president for the year after. 

 

Varmus Discusses Grant Policy, Changes in Congress and Ebola

NCI Director Harold Varmus addressed a joint meeting of the NCI Board of Scientific Advisors and the National Cancer Advisory Board Dec. 2, updating them on his proposed bypass budget for the institute, changes in Congressional leadership, and NCI and NIH grant policy.

NCI’s Douglas Lowy and John Schiller Honored with National Medal

NCI’s Douglas Lowy and John Schiller were honored by President Barack Obama with a National Medal of Technology and Innovation, the nation’s highest honor for technological achievement, for their work in developing a vaccine for human papilloma virus.

 

Obituary

Lee Wattenberg, 92, “Father of Chemoprevention”

Lee Wattenberg, emeritus professor of laboratory medicine and pathology at the University of Minnesota Masonic Cancer Center, died Dec. 9 at the age of 92. 

His research established the discipline of chemoprevention. Wattenberg first recognized that some compounds could effectively block the development of carcinogens in animals. In 1966, he published a paper in the journal Cancer Research that reviewed 36 years of animal studies on the effects of certain compounds on carcinogenesis and laid the framework for our understanding of how these compounds work. It was in this paper that he introduced the term chemoprophylaxis. 

Regulatory Approvals

  • Gardasil 9 approved, which covers five additional HPV types
  • FDA grants Fast Track designation to DPX-Survivac cancer vaccine
  • FDA approves a new indication for Xgeva (denosumab)
  • FDA approves MP Diagnostics HTLV Blot 2.4 test
  • FDA grants clearance for SAVI SCOUT surgical guidance system
In Brief

  • Weldon Gage named CFO at MD Anderson Cancer Center

  • Marcelo Bento Soares named senior associate dean at University of Illinois College of Medicine at Peoria

  • Boris Kuvshinoff II named chief medical quality officer and interim chief medical officer at Roswell Park Cancer Institute

  • David Currow named director of palliative medicine and hospice care at Dartmouth-Hitchcock

  • Joanna Weiss appointed VP of revenue cycle management at Moffitt Cancer Center

  • American Cancer Society publishes second edition of The Cancer Atlas

  • Marlo Thomas receives Presidential Medal of Freedom

  • RxTrials and Clinical Oncology Research Excellence form collaboration

  • Yale University and Organovo Holdings Inc. partner to research 3D printed tissues

  • Pharmacyclics receives award for Imbruvica

  • The CrowdCare Foundation announces myeloma research crowdfunding initiative

  • Seattle Children’s launches Strong Against Cancer fundraiser

20141212 - Dec. 12, 2014