publication date: Dec. 17, 2013


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LENORA JOHNSON was named director of health education, communications, and science policy at the National Heart Lung and Blood Institute. Johnson will be leaving her job as director of the NCI Office of Communications and Education. Johnson will be leaving NCI Dec. 13.

Johnson has served as OCE director for over seven years.

“While this is a tremendous opportunity for her, Lenora’s departure is a huge loss for the Institute,” John Czajkowski, NCI deputy director for management, wrote in a recent memo to the staff.

Nelvis Castro was appointed acting director of OCE. Also during the transition, Peter Garrett will join NCI as senior advisor for communications to NCI Director Harold Varmus.

Garrett is the director of communications and public affairs at HHS Office of the National Coordinator for Health Information Technology. He replaces Rick Borchelt who left for the Department of Energy Office of Science in August.

NCI spends more than any other NIH institute on public relations and education activities, and Johnson’s office has been undergoing unprecedented scrutiny and budget cuts.

The Cancer Letter published a series of stories on the NCI spending on PR and education, and the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce launched an investigation.

NCI spent $46.2 million on these activities in fiscal 2012. However, Varmus has cut the budget by about 15 percent this year, as part of his response to sequestration, and is expected to cut another 15 percent in fiscal 2014, bringing the budget down to about $30 million a year.

The NHLBI budget for PR and education was around $10 million in fiscal 2012.


A Series by The Cancer Letter On the Cost of Cancer Communications

Dec. 7, 2012: “Is $45 Million Too Much to Spend on PR? NCAB Panel Weighs NCI Communications Budget”

Feb. 1: “NCI Ends Brash Foray Into the News Business—Emails Tell the Story of the NCI Cancer Bulletin”

March 1: “NCI Spent $381.2 Million on PR from 2006 to 2012, Vastly Outspending Other NIH, FDA Units”

March 15: “Nature Editorial Criticizes NCI PR spending”

June 14: “FASEB: Focus on Research Funding, Not PR”

• July 12: “NIH Spent $181.3 Million on PR Last Year; House Probe Prompts Analysis of Spending.”


ADRIENNE LANG
, vice president for executive operations at MD Anderson Cancer Center, is stepping down from her position. The resignation was announced in an email from MD Anderson President Ronald DePinho. Her last day will be Dec. 31.

Lang served as interim senior vice president for institutional advancement, and as DePinho’s chief of staff since his arrival.

She joined MD Anderson in 1998 as assistant director of governmental relations, and also served as chief of staff for John Mendelsohn, who was president of the center from 1999 to 2011.

“Her strong relationships with The University of Texas System Board of Regents and officers, as well as the MD Anderson Board of Visitors, have been invaluable to me,” wrote DePinho.


MICHAEL FOLEY
was selected to lead the Tri-Institutional Therapeutics Discovery Institute Inc., a collaboration of Weill Cornell Medical College, The Rockefeller University, and Memorial Sloan-Kettering Cancer Center, which will focus on early-stage drug discovery.

Foley will be the Sanders Director of Tri-I TDI, and director of its Sanders Innovation and Education Initiative, in recognition of the $15 million gift from Lewis and Ali Sanders to help establish the Institute.

He is scientific co-founder of four companies and one academic institute, and has placed 12 single-agent or combination drugs into clinical development. He was most recently director of the chemical biology platform at the Broad Institute of Harvard and MIT. He also worked at Bristol-Myers Squibb and GlaxoSmithKline.

The institute was formally launched in October and formed its first collaboration with Takeda Pharmaceutical Company Ltd. to develop small-molecule drugs.


THE AMERICAN ASSOCIATION FOR CANCER RESEARCH
announced that Beti Thompson will present the fourth annual AACR Distinguished Lecture on Cancer Health Disparities, funded by Susan G. Komen.

Thompson, associate program head and associate director for health disparities research in the Cancer Prevention Program of Fred Hutchinson Cancer Research Center, will deliver her lecture Dec. 6, during the opening plenary session of the AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved.

Thompson is being recognized for her key role in developing one of the nation’s pre-eminent programs in cancer health disparities, and for her research in the design and implementation of community approaches to reducing cancer health disparities in minority and other underserved populations.

In her lecture, she will discuss lack of access to care in terms of cancer prevention behavior among Hispanic populations. She will examine community-based, participatory research initiatives and the effect of such programs on increasing colorectal cancer screenings.

FDA News


FDA approved a supplemental new drug application for Nexavar tablets (sorafenib)
for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment. The expansion of Nexavar’s label was approved following a priority review by the FDA.

The approval was based on the results of the DECISION trial, an international, multicenter, placebo-controlled study.

A total of 417 patients with locally recurrent or metastatic, progressive differentiated thyroid carcinoma refractory to radioactive iodine treatment were randomized to receive 400 mg of oral sorafenib twice daily (n=207) or matching placebo (n=210). Metastases were present in 96 percent of the patients: lungs in 86 percent, lymph nodes in 51 percent, and bone in 27 percent.

Sorafenib significantly extended progression-free survival, the study’s primary endpoint. The median PFS was 10.8 months (95% CI 9.1-12.9) among patients treated with sorafenib compared to 5.8 months (95% CI 5.3-7.8) among patients receiving placebo (HR=0.59 [95% CI, 0.46, 0.76]; p<0.001).

Nexavar is approved in the U.S. for the treatment of patients with unresectable hepatocellular carcinoma, patients with advanced renal cell carcinoma and patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.

Nexavar is thought to inhibit both the tumor cell and tumor vasculature. In in vitro studies, Nexavar has been shown to inhibit multiple kinases thought to be involved in both cell proliferation and angiogenesis, including Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.

Nexavar is co-developed by Bayer HealthCare and Onyx Pharmaceuticals Inc., an Amgen subsidiary.


FDA granted 510(k) clearance to an estrogen receptor image analysis and digital read application
for breast cancer. The Companion Algorithm ER (SP1)1 image analysis algorithm is used with the iScan Coreo scanner running Virtuoso2 software, and is developed by Ventana Medical Systems Inc., a member of the Roche Group.

There are two intended uses: first, clinical use of the software algorithm to semi-quantify the ER biomarker; and digital read, or clearance to manually read and score the ER biomarker using a computer monitor, in lieu of a microscope. The pathologist will be able to digitally view a slide on a computer monitor, assign a score, and then sign out the case with a diagnosis or opinion, with or without the assistance of an image analysis algorithm.

Along with the Companion Algorithm ER (SP1) image analysis software, the full breast panel includes HER2 (4B5), PR (1E2), Ki-67 (30-9) and p53 (DO-7) image analysis algorithms along with their accompanying Ventana IHC assays.


FDA approved the Aptima HPV 16 18/45 genotype assay
for use on the Panther system. Both are produced by Hologic Inc. The Aptima HPV 16 18/45 genotype assay uses ThinPrep liquid cytology specimens, and is intended to be tested from the same sample that has already received Aptima HPV assay positive results.

In patients 21 years and older with atypical squamous cells of undetermined significance cervical cytology results, the assay can be used to test samples from women with Aptima HPV assay positive results to assess the presence or absence of high-risk HPV genotypes 16, 18 and/or 45. The results of this test are not intended to prevent women from proceeding to colposcopy.

In patients 30 years and older, the assay can be used to test samples from women with Aptima HPV assay positive results. The assay results will be used in combination with cervical cytology to assess the presence or absence of high-risk HPV genotypes 16, 18 and/or 45.

The assay is the first FDA-approved test for genotyping human papillomavirus types 16, 18 and/or 45.

Although HPV genotype 45 is fairly uncommon, identified in only 0.4 percent of women with normal cytology, data indicates that it is the third most common HPV genotype in invasive cancer.

The assay received FDA approval on the Hologic Tigris high-throughput system in October 2012.

FDA granted Priority Review to ramucirumab as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy.

Priority Review status means that the FDA’s goal is to take action within eight months of a completed filing. Eli Lilly and Company, the drug’s sponsor, anticipates agency action on this application in the second quarter of 2014.

The application was based on data from REGARD, a global, randomized, double-blind phase III study of ramucirumab plus best supportive care compared to placebo plus best supportive care as a treatment in patients with advanced gastric cancer, including adenocarcinomas of the gastro-esophageal junction, following progression after initial chemotherapy.

Lilly also studied ramucirumab in combination with paclitaxel for the treatment of advanced gastric cancer in its phase III RAINBOW trial.

The combination-therapy ramucirumab data from that trial will be the basis for separate regulatory applications. Lilly expects top-line results from three additional phase III trials of ramucirumab, one each in colorectal, hepatocellular and lung cancer, in 2014.

Ramucirumab is a human, receptor-targeted antibody that specifically blocks the vascular endothelial growth factor receptor 2 and inhibits downstream signaling involved in the formation and maintenance of aberrant blood vessels that supply blood to tumors.


FDA and the European Medicines Agency granted orphan drug designation to IMAB362
for the treatment of pancreatic cancer. IMAB362 is a monoclonal antibody currently in phase IIb clinical trial in gastroesophageal cancer.

Orphan drug designation is given to investigational new drugs that are under development for the treatment of life-threatening or very serious diseases that affect fewer than 200,000 patients in the U.S. or less than 5 in 10,000 individuals across Europe.

IMAB362 is a monoclonal antibody selectively binding to the tight junction protein CLDN18.2, which is expressed in approximately 60 percent of primary and metastatic pancreatic cancers. CLDN18.2 is also expressed in up to 80 percent of gastroesophageal cancers as well as in other solid tumors. However, CLDN18.2 is absent from the vast majority of healthy tissues.

IMAB362 is being developed by Ganymed Pharmaceuticals AG.

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