20150206 - Feb 6, 2015
ISSUE 5 – FEB. 6, 2015PDF

As Biosimilar GCSF Looms Over U.S. Market, Big Players Line Up for Emerging Competition

In the next few weeks, FDA will announce its decision on Novartis’s Zarxio, a granulocyte-colony stimulating factor biosimilar to Amgen’s Neupogen.

If it’s approved—and outside observers uniformly believe it will be—Zarxio will become the first biosimilar agent to enter the U.S. market. Indeed, the FDA Oncologic Drugs Advisory Committee last month unanimously gave it thumbs up.

Being the first, Zarxio will provide a case study in the pricing of these agents.

Conversation with The Cancer Letter

Conti: Don’t Count on an 80% Price Drop From the Launch of Neupogen’s Biosimilar

Introduction of biosimilar biologics will not bring about the same price drops as introduction of generic small-molecule drugs, said Rena Conti, an economist at the University of Chicago, whose work focuses on drug pricing.

With small-molecule drugs, price drops within two years of patent expiration and the introduction of generics can amount to 80 to 90 percent off the branded price.

The price drop for biologics when biosimilars enter the market will be less dramatic, in part because only a small number of companies have the ability to produce these agents, reducing the competitive pressure that drives down prices. In addition, the costs of manufacturing biosimilar agents is higher than those associated with manufacturing generic small-molecule agents.

Medicare to Begin Coverage Of CT Lung Cancer Screening

Computed tomography screening has become a benefit for Americans covered by Medicare.

The Centers for Medicare and Medicaid Services Feb. 5 published a final decision to cover screening of current and former smokers, provided they meet stringent eligibility criteria.

Beneficiaries will go through counseling, health professionals will be required to provide documentation that “shared decision-making” took place, technical criteria for screening will be met, and data will be collected. CMS has never mandated shared decision-making as a gateway to paying for a service.

Obama Proposes $1 Billion Increase for NIH in 2016

NIH would receive a $1 billion funding boost in President Barack Obama’s $4 trillion 2016 budget—a 3 percent increase—should Congress pass his proposal. 

The additional funds would bump the NIH budget to $31.3 billion, which the White House said would support greater research in cancer, Alzheimer’s and other diseases. The proposal provides $38.8 billion in discretionary funding to the Department of Health and Human Services.

The proposal also includes $135 million for NIH’s contribution to the BRAIN Initiative, a research project announced by Obama on April 2, 2013, aimed at accelerating the development and application of innovative technologies to map the human brain.

FDA Commissioner Margaret Hamburg To Step Down Next Month

FDA Commissioner Margaret Hamburg announced that she will be stepping down at the end of March 2015.

In an email to colleagues Feb. 5, Hamburg, 59, reflected on her six-year run in the top job at the agency, and called her decision to leave “not easy.”

“My tenure leading this agency has been the most rewarding of my career, and that is due in no small part to all of you,” she wrote.

Hamburg was nominated by President Barack Obama and confirmed by the Senate in 2009.

World Cancer Day

UICC: Adding $18 Billion a Year Could Drop Cancer Deaths By 30% in Poorer Countries

New data projects that an $18 billion increase in funding per year by the international community could result in a 30 percent reduction in cancer deaths in low- and middle-income countries by 2030.

On World Cancer Day 2015, held annually Feb. 4, public health experts from the Union for International Cancer Control said that millions of lives can be saved through affordable increases in the investment into cancer services throughout the world.

CVS Provided Counseling To 67,000 in Four Months After Halting Sales of Tobacco

A year after it announced its decision to stop tobacco sales, CVS Health released data that shows how its stores are working to deliver the anti-smoking message.

According to CVS, from the launch of the program on Sept. 3, 2014, through December 2014, its pharmacists counseled more than 67,000 patients filling a first prescription for a smoking cessation drug or prescription nicotine replacement therapy.

Funding Opportunity

Crowd Research Initiative Taking Proposals in Myeloma

The Myeloma Crowd Research Initiative is accepting research proposals for high-risk multiple myeloma until the end of February, through the Myeloma Crowd website. The Myeloma Crowd is a division of the CrowdCare Foundation.

In Brief

  • Candace Johnson named president and CEO of Roswell Park Cancer Institute

  • Thomas Rutherford named physician director of the Western Connecticut Health Network

  • Carolyn Compton to lead Indivumed scientific advisory board

  • Eli Lilly donates $1 million to Kenyan health care program

Drugs and Targets

  • FDA grants accelerated approval to Ibrance in metastatic breast cancer

  • FDA approves Koning Breast CT 3D scanning system

  • Yondelis granted priority review in advanced soft tissue sarcoma

  • MPDL3280A receives second breakthrough therapy designation

20150130 - Jan 30, 2015
ISSUE 4 – JAN. 30, 2015PDF

Guest Editorial
SWOG Chair Blanke to Climb Mt. Kilimanjaro to Draw Attention to Clinical Trials Funding

By Charles D. Blanke

Rising 19,341 feet above sea level, Mt. Kilimanjaro is the highest mountain in Africa and the tallest freestanding mountain in the world. It is a dormant but non-extinct volcano which last erupted some 150,000 years ago. 

Next week I will climb Mt. Kilimanjaro to draw attention to the risks posed by financial cuts to publicly funded cancer clinical studies, to raise funds to help fill the gaps those cuts have left, and to pay homage to some 200,000 SWOG trial volunteers.

 


Draft Bill Seeks to Revamp FDA, NIH, CMS To Accommodate 21st Century Science

The House Committee on Energy and Commerce Jan. 27 released a draft version of a massive bill that seeks to streamline the pathways of innovation in medicine.

The 393-page “discussion document,” which sets forth the committee’s long-awaited 21st Century Cures initiatives, includes proposals reworking many important structures in funding medical research and the regulatory approval processes—from strengthening the authority of the NIH director and boosting the size of the NIH Common Fund, to including new incentives for makers of orphan and generic drugs to changing the manner in which FDA reviews drugs and devices. 

Duke Trial Delayed, But University to Turn Over More Documents

The trial stemming from Duke University’s clinical trials of a fraudulent genomic technology has been delayed, most likely until September.

The attorneys who represent the seven plaintiffs in Aiken vs. Duke initially sought the delay. Struck by the flu, the attorneys, including the lead counsel, were in no condition to deliver opening arguments Jan. 26.

However, even as the principal case has been continued, the judge in Durham County Superior Court Jan. 29 heard an argument over discovery, ordering Duke to turn over additional materials to the plaintiffs.

Duke’s Califf to take No. 2 Job at FDA

Robert Califf was named FDA Deputy Commissioner for Medical Products and Tobacco, a de facto No. 2 post at the agency.

Califf, 63, an expert in cardiology, clinical research, and medical economics, is leaving his job as vice chancellor of clinical and translational research at Duke University. He will join the agency in late February.

Califf will oversee the FDA Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products. He will also oversee the Office of Special Medical Programs in the Office of the Commissioner.  

Desequestration? Obama, Congress Seek to Restore Federal Funding

President Barack Obama and several members of Congress announced a slew of initiatives this week aimed at eliminating the effects of sequestration for the government, and for medical research by providing increases for NIH and other federal agencies.

Two bills introduced in Congress would provide sustained increases by boosting funding through direct appropriation and by adjusting caps established in the Budget Control Act.

The American Cures Act, introduced by Sen. Dick Durbin (D-Ill.), would adjust the budget caps to allow for 5 percent annual funding increases over 10 years for NIH, CDC, the Department of Defense Health Program, and the Veterans Medical & Prosthetics Research Program.

Funding Opportunity

SITC and Merck Offering Immunotherapy Fellowship

The Society for Immunotherapy of Cancer, with support from Merck, is providing funding for cancer immunotherapy research through the SITC-Merck Cancer Immunotherapy Clinical Fellowship 

In Brief

  • Scott Strong named chief of GI surgery at Northwestern Memorial Hospital

  • James Orr named chair of Florida Board of Medicine

  • Columbia University eliminates its mesothelioma center

  • BBVA Foundation names winners of Frontiers of Knowledge Award in Biomedicine

  • Cancer Treatment Centers of America partners with National Football League Alumni Association 

  • MD Anderson begins collaboration with AstraZeneca in gynecologic cancers

  • UC San Diego and UC San Francisco to launch Cancer Cell Map Initiative

Drugs and Targets

  • FDA adds Waldenström’s macroglobulinemia to Imbruvica label

  • FDA grants orphan drug designations to tarextumab in pancreatic cancer and small cell lung cancer

  • Health Canada grants device approval to xTAG CYP2D6 Kit v3

  • Array BioPharma reaches agreement with Novartis PharmaAG

  • Amgen and Onyx Pharmaceuticals submit applications for Kyprolis

20150123 - Jan 23, 2015
ISSUE 3 – JAN. 23, 2015PDF

CMS Opens Door to Coverage of Comprehensive Genomic Sequencing

At first glance, it’s hard to imagine anything as obscure as a policy by a private contracting firm that runs the Medicare program in the Carolinas, Virginia and West Virginia.

But look closer: a “local coverage determination” by Palmetto GBA addresses an urgent, vexing problem of precision oncology: how advanced molecular testing can be used to determine treatment options for individual patients and what insurers will be willing to pay for. 

The coverage determination, titled “Comprehensive Genomic Profiling for Non-Small Cell Lung Cancer” popped up on a government website well after close of business Jan. 22. There was no press release; no rollout whatsoever.

Nonetheless, the decision may introduce clarity into the informational pea-soup fog that engulfs molecular testing by spelling out the criteria for opening payment for complex tests and comprehensive genomic assays, which measure multiple markers.

As it stands, the vast majority of assays that cost thousands of dollars and are used to determine treatment for cancer patients are not reviewed by government agencies before they enter the marketplace.

 


 

Duke’s Legal Stance: We Did No Harm

Attorneys defending Duke University are preparing to argue that no patients were harmed in the institution’s phase II clinical trials of genomic predictors that were later shown fraudulent.

The technology in question came from the laboratories of Duke stars Joseph Nevins and Anil Potti, and was based on findings that, from the outset, seemed too good to be true—and were ultimately discredited and retracted. 

The suit claims negligence, breach of fiduciary duty, unjust enrichment, infliction of emotional distress, loss of chance, battery, deceptive trade practices, civil conspiracy and obstruction of justice.

The trial is scheduled to begin Jan. 26 at Durham County Superior Court. Altogether, 117 patients enrolled in the three clinical studies at Duke.

The essence of Duke’s argument—which forms the basis of a flurry of motions for a partial summary judgment—is that patients who entered the clinical studies were, for the most part, in late stages of disease and that the predictor models were used to assign them to existing therapies. 

News Analysis
Misconduct Expert Dissects Duke Scandal

By C. K. Gunsalus

On Jan. 9, 2015, The Cancer Letter reported that Duke University received information in early 2008 that called into question the validity of the methodology and results published by the Anil Potti research group. Potti, along with his mentor and co-author Joseph Nevins, had galvanized the world of cancer research in 2006 and 2007 with their reports of successful gene expression tests for directing cancer therapy, the “holy grail” of cancer research. The 2008 information came in the form of a letter from a third-year medical student, Brad Perez, who was working in Potti’s lab. The letter, which does not seem to have been given any credence at the time, described with precision the problems that eventually resulted in the termination of clinical trials and the subsequent retractions, beginning in 2011, of at least ten (and counting) papers from major scientific journals. 

Cancer Drug Prices Increased $8,500 Per Year Since 1995

The launch prices of anticancer drugs have increased substantially over time—even when adjusted for inflation and survival benefits—according to a study published by the National Bureau of Economic Research.

 

State of the Union 2015
Obama Launches Precision Medicine Initiative

President Barack Obama called for innovation in genetic medicine, through the launch of a new initiative, in his State of the Union address Jan. 20.

“Twenty-first century businesses will rely on American science and technology; research and development,” Obama said.

“I want the country that eliminated polio and mapped the human genome to lead a new era of medicine—one that delivers the right treatment at the right time. In some patients with cystic fibrosis, this approach has reversed a disease once thought unstoppable,” he said.

“So tonight, I’m launching a new precision medicine initiative, to bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalized information we need to keep ourselves and our families healthy.”

ASCO Teams with SAP For CancerLinQ Project

The American Society of Clinical Oncology announced Jan. 21 that its CancerLinQ health information technology project will use the SAP HANA platform.

SAP HANA is a flexible, in-memory data management and application platform that provides predictive text analytics, spatial processing and data virtualization. SAP has teamed with medical organizations in Germany and Japan for cancer data analytics and genomic analysis. 

Letter to the Editor
Is $100M in Stock Enough to Make MD Anderson Go Public with its Conflict-of-Interest Management Plan?

By Leonard Zwelling

Last week, it was reported in both The Cancer Letter and the Houston Chronicle that The University of Texas MD Anderson Cancer Center had closed a deal to sublicense intellectual property to two pharmaceutical firms, Intrexon and Ziopharm Oncology. There is nothing terribly unusual about that.

The deals, however, were mostly in exchange for equity, $50 million in stock from each company plus $15-20 million per annum. The technology is chimeric antigen receptor T cells (CAR T) and The Cancer Letter article suggests that the clinical trials testing the technology’s efficacy will be done at MD Anderson, at least in part.

This struck me as odd.

Letter to the Editor
LLS President Responds To “Bad Luck” Cancer Study

By Louis J. DeGennaro

A new study indicates that the risk of developing cancer in some types of tissue is based on the frequency of stem cell divisions, and therefore beyond individuals’ control to minimize their own risks. As the study stated, a majority of these cancers develop due to random mutations of noncancerous stem cells; in other words, it’s just “bad luck.”

In Brief

  • Moffitt’s Johnathan Lancaster to join Myriad Genetics

  • Sue Biggins receives prize from Genetics Society of America

  • Pancreatic Cancer Action Network and NCI’s Frederick National Lab award two fellowships

  • Caris Life Sciences establishes Caris Centers of Excellence for Precision Medicine Network

  • City of Hope and Trovagene Inc. enter into clinical collaboration

  • WuXi PharmaTech acquires NextCODE Health

  • Medical University of South Carolina location upgrades imaging systems

  • Royal Phillips partners with Indica Labs Inc.

  • Picador acquires world publishing rights to the debut novel by Paul Goldberg, editor and publisher of The Cancer Letter

Drugs and Targets

  • European Medicines Agency’s CHMP issues positive opinion on Jakavi for Polycythemia Vera

  • Palmetto GBA publishes CMS coverage policy for Decipher prostate cancer classifier

  • Ventana Medical Systems submits ALK assay for FDA premarket approval