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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FDA published two draft guidance documents Oct. 3 for regulatory oversight, notification and medical device reporting for laboratory developed tests.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
ISSUE 36 – SEPT. 26, 2014PDF



Colorado Institutions Vying to Build First Carbon Ion Center in the U.S.

The University of Colorado and Colorado State University are vying to become the first institution to build a carbon-ion radiotherapy research and treatment facility in the U.S. The treatment modality is available in Europe and Japan.

Officials at the two universities are exploring the feasibility of building a $300 million research and treatment facility at the University of Colorado Anschutz Medical Campus in Aurora.

Their first step is to conduct a $200,000 feasibility study for the project.

Conversation with The Cancer Letter
Pat White: NIH Funding “Our Only Concern”

A lobbying campaign will make an effort to secure an immediate, significant funding increase for NIH.

The effort, called ACT for NIH: Advancing Cures Today, seeks to bring together patients, scientists, advocates, and lawmakers on both sides of the aisle. Their objective is to demonstrate the impact of a decade of clamping down on NIH funding. Adjusted for inflation, NIH receives nearly 25 percent less funding than it did in 2003.

Gonzalez-Angulo Found Guilty in MD Anderson Poisoning Case

HOUSTON—Ana Maria Gonzalez-Angulo, a 43-year-old breast cancer specialist at MD Anderson Cancer Center, was found guilty of poisoning her lover, George Blumenschein, another medical oncologist at MD Anderson.

A jury at the Harris County 248th District Criminal Court found Gonzalez-Angulo guilty of aggravated assault Sept. 26. The court immediately went into the penalty phase of the proceedings.

Guest Editorial
“Gizmo Idolatry” and Marketing Da Vinci’s Radical Robot

In America, cutting-edge inventions are seen as the gateway to the future. However, the hazard of credulously accepting new technology into medical practice was warned against in a 2008 Journal of the American Medical Association editorial “Gizmo Idolatry.”

The term “gizmo idolatry” describes the conviction that a high-tech approach is better than a low-tech approach, even if there’s no evidence to support that view. A glaring example of medical “gizmo idolatry” is the da Vinci Surgical System. Without credible data to prove its safety and benefit in complex surgeries, this costly robotic machine has been promoted into near ubiquitous use in hospitals across the nation. 

MD Anderson Expands Reach Into Florida, Ohio

Two institutions said they are in varying stages of completing partnerships with MD Anderson Cancer Center.

The two deals are a part of an expansion strategy that essentially means that the MD Anderson logo can light up almost anywhere, establishing the Houston-based cancer center as a potential competitor to almost any cancer center in the U.S.

NCI Starts “Exceptional Responders” Study

NCI has launched a pilot study to investigate the molecular factors of tumors associated with exceptional treatment responses of cancer patients to drug therapies.

The Exceptional Responders Initiative seeks to identify the molecular features of tumors that predict whether a particular drug or class of drugs will be beneficial. 

photoIn Brief

  • Doug Ulman named CEO of Pelotonia

  • Margaret Foti honored by Friends of Cancer Research

  • Wilshire Oncology Medical Group joins City of Hope

  • The West Clinic receives National Committee for Quality Assurance recognition

  • FDA awards Critical Path Institute $2.1 million

  • Beth Israel Deaconess Medical Center and Cancer Genetics Inc. enter collaboration

  • FASEB publishes factsheet on federal research funding by congressional district

  • Lisa Stockmon named City of Hope chief communications officer 

  • FDA names recipients Drug Shortage Assistance Award

  • European Head and Neck Society calls for EU program

  • QVC and Fashion Footwear Association of New York present $240,000 to University of Pittsburgh Cancer Institute

20140926 - Sep. 26, 2014