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ISSUE 6 – FEB. 13, 2015PDF

NCI to Spend $70 Million on Precision Oncology in Presidential Initiative, Even if Congress Doesn’t Appropriate New Funds, Varmus Says

NCI will implement President Barack Obama’s directive to ramp up the initiative in precision medicine, even if Congress doesn’t appropriate specific funds for this purpose, Institute Director Harold Varmus told members of the National Cancer Advisory Board Feb. 12.

The White House budget proposal for fiscal 2016 includes $200 million for NIH to spend on the Precision Medicine Initiative. On top of that, the proposal includes a 3.2 percent overall budget increase.

For NCI, this would mean a $70 million boost for precision medicine in oncology—some on work that’s already underway, Varmus said. 

Tufts Researchers Say Blood Cancer Drugs Are a Good Value; Kantarjian Disagrees

Even at high cost, blood cancer drugs provide a good value, an analysis by Tufts Medical Center researchers found.

In a paper published online by the American Society of Hematology journal Blood, the Tufts team presents data from a meta-analysis to argue that, even considering their cost of $100,000 or more a year, targeted therapies, as they translate into years and quality of life gained, may justify the prices.

“Given the increased discussion about the high cost of these treatments, we were somewhat surprised to discover that their cost-effectiveness ratios were lower than expected,” Peter Neumann, director of the Center for Evaluation of Value and Risk in Health at Tufts and the senior author of the study, said in a statement.

MD Anderson Pediatrics Chair “Resigned” To Pursue Academic Interests—Or Did She?

According to MD Anderson administration, Eugenie Kleinerman “decided to step down as Head, Division of Pediatrics, and Chair, Department of Pediatrics, effective Feb. 9 in order to pursue her interests in new initiatives in adolescent and young adult cancer.”

This was the version of events promulgated by MD Anderson Provost Ethan Dmitrovsky. 

Leonard Zwelling, a former MD Anderson executive and Kleinerman’s husband, offers another version. 

ACS: Tobacco May Kill More Than Previously Estimated

Cigarette smoking may kill tens of thousands more from diseases that are not currently counted as caused by smoking, according to a decade-long study led by American Cancer Society researchers.

Published in the New England Journal of Medicine, the new study included data from nearly a million U.S. men and women age 55 or older that enrolled in five U.S. cohort studies—the American Cancer Society’s Cancer Prevention Study-II, the Nurses’ Health Study, the Health Professionals Follow-up Study, the Women’s Health Initiative, and the National Institutes of Health-AARP Diet and Health Study.

CMS Announces New Model For Payment & Care Delivery

The Centers for Medicare and Medicaid Services announced the “Oncology Care Model,” a multi-payer payment and care delivery model to support care coordination of cancer care.

BRCA Testing Rates Jump After Angelina Jolie Story

BRCA gene testing rates increased by nearly 40 percent in the week of Angelina Jolie’s 2013 announcement that she carried the BRCA 1 gene mutation and had an elective double mastectomy, according to a new AARP Public Policy Institute study released Feb. 11. 

This is the first report quantifying an increase in BRCA testing rates among women enrolled in a large U.S. health insurance carrier.

In Brief

  • Karl Deisseroth awarded Lurie Prize for cell and tissue imaging

  • Douglas Lowy receives Harrington Prize for work on HPV vaccine

  • UT Southwestern and a Texas consortium to establish first U.S. heavy ion radiation therapy center

  • Wendy Selig to step down as president and CEO of the Melanoma Research Alliance

  • Multiple Myeloma Research Foundation and Inflection Biosciences announce collaboration

  • Northwestern University to launch Onco-SET precision medicine program

Drugs and Targets

  • E.U. expands Velcade label to include mantle cell lymphoma

  • FDA ODAC to review talimogene laherparepvec

  • Merck to assume full responsibility for Erbitux in Japan from Bristol Myers-Squibb

  • FDA grants orphan drug designation to Reolysin

  • Roche acquires Signature Diagnostics AG

20150213 - Feb. 13, 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

20150206 - Feb. 6, 2015
January 2015PDF

 Colorectal Cancer

Amgen Presents Phase II and III Vectibix Studies in Wild-Type RAS Colorectal Cancer

Amgen presented data from the phase II PEAK and phase III PRIME studies evaluating first-line use of Vectibix (panitumumab) in combination with FOLFOX chemotherapy regimen in patients with wild-type RAS metastatic colorectal cancer.

In an exploratory analysis from the phase II study, treatment with Vectibix compared to Avastin (bevacizumab) resulted in a significantly higher proportion of patients with earlier tumor shrinkage at week eight (64 percent vs. 45 percent, respectively; 95 percent CI, p=0.0232), and among responding patients, a significantly longer duration of response (11.4 vs. 8.5 months, respectively; 95% CI, p=0.0142) and greater depth of response (65 percent vs. 46 percent, respectively; p=0.0007). 

 Lung Cancer

Two Phase III LUX-Lung Trials of Gilotrif Demonstrate Benefits in Overall Survival

Two independent phase III clinical trials, LUX-Lung 3 and LUX-Lung 6, in epidermal growth factor receptor mutation-positive metastatic non-small cell lung cancer demonstrated positive results in overall survival.

In each trial, patients whose tumors have the most common EGFR mutation—deletion in exon 19—lived more than one year longer when treated with first-line afatinib (Gilotrif) compared to standard chemotherapy. The data was published in The Lancet Oncology.

 Drugs and Targets

FDA Approves Opdivo in Metastatic Melanoma

FDA approved Opdivo (nivolumab) injection for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.

This indication was granted under an accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Opdivo is sponsored by Bristol-Myers Squibb Company.

The efficacy of Opdivo was evaluated based on a single-arm, non-comparative planned interim analysis of the first 120 patients who received Opdivo with a minimum of six months follow-up in the phase III CheckMate-037 trial.

Also: Updated approvals for Imbruvica, Gazyva and the MarginProbe medical device

 Breast Cancer
Phase III MARIANNE Study Fails To Improve PFS with Kadcyla
 Polycythemia Vera
Jakavi Trial Shows Hematocrit Control Without Phlebotomy
CPX-351 Shows Clinical Benefit In Poor-Risk AML in Phase II
 NCI CTEP-Approved Trials for the Month of January
20150202 - Feb. 2, 2015