publication date: Mar. 6, 2015
20150306 - Mar. 6, 2015
ISSUE 9 – MARCH 6, 2015PDF

News Analysis
The Years With Harold

The National Cancer Institute Harold Varmus will leave on March 31 is leaner, cleaner, and more focused than it was on July 12, 2010, the day he became its 14th director. 

Chalk it up to irony, but the first phase of the Nobel laureate’s stewardship at the circa-$5 billion-a-year institution can be classified as janitorial work—clearing out the pet projects of his predecessors.

The Andrew Von Eschenbach-era dysfunctional bioinformatics and biorepository projects got the defenestration they deserved. The institute’s outsized PR operation got edited down with deft ax work. 


FDA’s Activism Changes the Landscape In Treatment, Trials of Squamous NSCLC

Citing a dramatic improvement in overall survival in second-line squamous non-small cell lung cancer, FDA rapidly approved the Bristol-Myers Squibb drug Opdivo (nivolumab).

The action, announced March 4, demonstrates the extraordinary activist stance FDA can take when it sees an advantage in overall survival. 

In this case, FDA received the data and sprung into action before the results were unblinded to the sponsor, said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. 

“With regard to the impetus for this rapid action, we began working immediately on this review and submission strategy after being informed of the survival results. This was prior to BMS having been informed of the results since they were still blinded,” Pazdur said to The Cancer Letter. 

NCI Director Harold Varmus To Step Down March 31

NCI Director Harold Varmus announced that he will be stepping down at the end of this month.

Douglas Lowy, the current deputy director, will serve as acting director for NCI beginning April 1. Lowy, a long-time NCI intramural researcher, received the National Medal of Technology and Innovation from President Barack Obama in 2014 for his research that led to the development of the human papillomavirus vaccine.

In a letter to colleagues March 4, Varmus, 75, reflected on his five years at the institute, saying that he is leaving with a “mixture of regret and anticipation.” 

From the Kilimanjaro Summit

By Charles D. Blanke

After months of training, hundreds of hours spent in a high-altitude sleep tent, and almost a week spent ascending the mountain, our climbing group was destined to have only 12 minutes at Mt. Kilimanjaro’s summit. However, that was enough to pay tribute to the 200,000 heroes who have participated in more than a half-century of SWOG cancer clinical trials.

 

FDA Approves Zarxio—First Biosimilar Drug

FDA approved Zarxio, making Sandoz’s granulocyte-colony stimulating factor the first biosimilar product to enter the U.S. market.

The agency announced its decision March 6. Biosimilars are approved based on a demonstration that they are similar to already-approved “reference” agents. 

Obituary

Mark Green, 70, Cancer Center Director

Mark Green, former director of Hollings Cancer Center at the Medical University of South Carolina and the University of California, San Diego, Moores Cancer Center, died Feb. 23, at the age of 70. 

Green was an important figure in the development of medical oncology and played a pivotal role in the history of both cancer centers.

Green received his MD from Harvard University and trained at Harvard’s Beth Israel Hospital, the NCI and Stanford University. In 1976, he joined UCSD, where he held the Edwin and Evelyn Tasch Chair in Cancer Research and served as director of the UCSD Cancer Center. In 1986, he led the center to its first NCI designation.

In Brief

  • Howard Bailey named director of UW Carbone Cancer Center

  • Meredith Mullins joins University of Arizona Cancer Center as associate director of administration

  • Silvia Formenti appointed chair of Department of Radiation Oncology at Weill Cornell Medical College

  • Phillip Sharp awarded Othmer Gold Medal by the Chemical Heritage Foundation

  • Andrew Robbins appointed chief operating officer of Array BioPharma

  • Indiana University and Lilly USA form medical student rotation program

  • Fred Hutchinson Cancer Research Center expands relationship with Cryoport Inc.

  • Memorial Sloan Kettering partners with PeraHealth

  • CMS approves American College of Radiology’s Lung Cancer Screening Registry

Drugs and Targets

  • FDA grants breakthrough therapy designation to EBV-CTL

  • CHMP issues positive opinion on Vectibix in metastatic colorectal cancer

  • FDA launches mobile app focused on drug shortage information

  • AbbVie acquires Pharmacyclics and Imbruvica

  • Bristol-Myers Squibb and Bavarian Nordic form agreement for Prostvac

  • Amgen launches Neulasta Delivery Kit

  • Array BioPharma completes two agreements with Novartis

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