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ISSUE 38 – OCT. 10, 2014PDF



NCI Failed to Publish Two Bypass Budgets

As Funds Tightened and Sequestration Set In

What’s the NCI director’s professional judgment of opportunities in cancer research at a time of shrinking budgets, sequestration and conclusion of the windfall of the American Recovery and Reinvestment Act?

Under ordinary circumstances, this question wouldn’t have required a mind reader. The NCI director has an authority no other government executive enjoys: every year, he submits a summary of scientific opportunities directly to the White House, bypassing review by the NIH director and officials at the place ominously called “Downtown,” the brutalist-style HHS headquarters at the base of Capitol Hill.

Guest Editorial
Andrew Vickers on PSA Skepticism, Rational and Irrational

I consider myself a prostate cancer screening skeptic. For example, in the title of the grand rounds lecture I have given for many years, I describe PSA as a “public health fiasco.”

I have also gone on the record to state: “PSA testing as it is commonly practiced in the U.S. is indefensible.”

UT Board Announces Support for MD Anderson Tenure System

The University of Texas System Board of Regents has—in response to the threat of censure by an external group—voted to continue support of MD Anderson Cancer Center’s seven-year term tenure system.

Study: Drug Discounts Used For Wealthier Patients In Many 340B-Enrolled Hospitals

Hospitals that qualified for the 340B drug pricing program in 2004 or later were more likely to serve wealthier communities with higher rates of health insurance coverage, according to a study published Oct. 6 in the journal Health Affairs.

The primary purpose of the 340B program—established by Congress in 1992—was to provide significantly discounted outpatient drugs to low-income and uninsured patients.

photoIn Brief

  • ESMO Names Annual Award Winners
  • Phoenix Children’s Hospital launches The Chan Soon-Shiong Children’s Precision Medicine Institute
  • C. Parker Gibbs Jr. appointed deputy director of medical affairs for the University of Florida Health Cancer Center.
  • MD Anderson Cancer Center’s Sheikh Khalifa Bin Zayed Al Nahyan Institute for Personalized Cancer Therapy launches fellowship program
  • Ohio State University completes five-year pharmaceuticals center project
  • MD Anderson and VolitionRx Limited announce collaboration
  • Andrew Brenner receives $1.62 million grant from FDA
photoDrugs and Targets

  • Akynzeo approved for chemotherapy-related nausea
  • DNX-2401 granted orphan drug designation
  • Caris Life Sciences launches pilot program through the U.K. National Health Service
  • Mayo Clinic partners with Second Genome Inc.
  • Bristol-Myers Squibb and MD Anderson collaborate on immunotherapies
  • PhRMA Report details nearly 800 cancer therapies currently in development
20141010 - Oct. 10, 2014
ISSUE 37 – OCT. 3, 2014PDF



Genentech Move Nixes Hospital Discounts

Avastin, Herceptin, Rituxan Now Sold Under Tighter Control by Drug Maker

A move by Genentech has eliminated discounts and rebates hospitals receive when they purchase three of the company’s top-selling infused cancer drugs.

Beginning Oct. 1, hospitals can now order Avastin (bevacizumab), Herceptin (trastuzumab) and Rituxan (rituximab) exclusively from six specialty distributors authorized by the drug maker.

Genentech said the move will bypass more than 80 full-line wholesale drug distribution centers, with the objective of enhancing efficiency and security of the supply chain for these widely used medications. 

Conversation with The Cancer Letter
Scott Soefje: “These are Life-Saving Drugs. I’m Not Going To Stop Treating Patients, Right?”

The loss of discounts and rebates hospitals received for administering Genentech’s Avastin, Herceptin and Rituxan will increase costs to patients, said Scott Soefje, director of pharmacy at University Medical Center Brackenridge in Austin.

Fake Avastin, Paid for by Medicare, Administered to U.S. Patients

Two years ago, British authorities tested a shipment of chemotherapy drugs headed for North America. 

They found that the agent, labeled as Genentech’s Avastin, contained no trace of Avastin’s active ingredient. The drugs were on the way to Canada, where they were to be sold to doctors throughout the U.S.

Gonzalez-Angulo To Serve 10 Years In Poisoning Case

Ana Maria Gonzalez-Angulo, a 43-year-old oncologist at MD Anderson Cancer Center, was sentenced to 10 years in prison for poisoning her lover and colleague George Blumenschein.

The sentence, issued Sept. 29, makes Gonzalez-Angulo ineligible for probation, but under Texas law, she will be eligible for parole in 5 years.

FDA Publishes Two Guidances for Lab-Developed Tests

FDA published two draft guidance documents Oct. 3 for regulatory oversight, notification and medical device reporting for laboratory developed tests.

Groups Push for CMS Coverage for LDCT Lung Screening

A coalition of patient advocacy and medical organizations urged the Centers for Medicare & Medicaid Services to cover low-dose computed tomography for Medicare patients at high risk for lung cancer.

Funding Opportunity
NYC-based Research Alliance Offering $200,000 Per Year for Young Investigators

The Pershing Square Sohn Cancer Research Alliance is taking applications for its Prize for Young Investigators in Cancer Research. The prize of $200,000 per year for up to three years is awarded annually to five New York City-based scientists.

photoIn Brief

  • Leonidas Platanias named director of Lurie Comprehensive Cancer Center

  • Karmanos Cancer Institute and Wayne State sign new affiliation agreement

  • Robert Miller named medical director of ASCO Institute of Quality

  • MD Anderson Cancer Center receives $10 million from ExxonMobil

  • Jan Egberts appointed CEO of Agendia Inc.

  • Memorial Sloan Kettering to open largest suburban location

  • CancerCare receives $1.5 million from Susan G. Komen

20141003 - Oct. 3, 2014
September 2014PDF

Breast Cancer 
Results from CLEOPATRA Phase III Trial Show Perjeta Increased OS 15.7 Months

Final phase III trial results showed that adding Perjeta to Herceptin and docetaxel chemotherapy increased overall survival to over four-and-a-half years in patients with previously untreated HER2-positive metastatic breast cancer.

Data from the CLEOPATRA study showed that the addition of Perjeta (pertuzumab) increased median overall survival 15.7 months compared to Herceptin (trastuzumab) and docetaxel alone—to 56.5 and 40.8 months, respectively. 

The data were presented at the Presidential Symposium at the European Society for Medical Oncology Congress in Madrid. 

Pancreatic Neuroendocrine Tumors

Afinitor Increases Overall Survival To 3.5 Years in Phase III Trial

An analysis of mature overall survival data from a phase III trial showed that Afinitor increased median overall survival by 6.34 months compared to placebo, for a total of over 3.5 years in patients with well-differentiated advanced and progressive pancreatic neuroendocrine tumors.

Overall survival was a secondary endpoint of the trial. The findings were presented at the European Society for Medical Oncology Congress in Madrid. Results from the primary analysis, which focused on progression-free survival, in which Afinitor (everolimus) more than doubled median PFS compared to placebo, were previously published in the New England Journal of Medicine.

Non-Small Cell Lung Cancer

Merck Serono Cancels Tecemotide Program In NSCLC, Including Two Phase III Trials

Merck Serono will discontinue its worldwide clinical development program of MUC1 antigen-specific immunotherapy tecemotide as a monotherapy in stage III non-small cell lung cancer. This includes the phase III START2 and INSPIRE studies.

The decision comes after a planned analysis of EMR 63325-009, a randomized, double-blind, placebo-controlled phase I/II study in Japanese patients with stage III unresectable, locally advanced NSCLC. Patients had received concurrent or sequential chemoradiotherapy with a minimum of two cycles of platinum-based chemotherapy and radiation dose greater than or equal to 50 Gy.

Multiple Myeloma
Phase III Trial: Panobinostat Increases PFS by Four Months
Gastric Cancer
Phase III Cyramza Trial Meets OS Primary Endpoint
Colorectal Cancer
Phase III Xilonix Study Halted Following Unscheduled Analysis
Ovarian Cancer
Cediranib/Olaparib Combination Nearly Doubles PFS in Phase II
Chemotherapy
Fidaxomicin for CDI Therapy More Cost-Effective Than Vancomycin 
NCI CTEP-Approved Trials for the Month of September
FDA News

  • Keytruda granted accelerated approval in metastatic melanoma

  • FDA approves new indication for Xtandi in prostate cancer

  • FDA removes clinical holds for two agents: ipafricept and PEGPH20

  • Soligenix Inc. reaches agreement with FDA on phase III trial design

20141001 - Oct. 1, 2014