publication date: Dec. 3, 2013


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In Brief

LARRY KUN was named clinical director and executive vice president of St. Jude Children’s Research Hospital.

He will oversee clinical operations, clinical effectiveness practices and patient care quality programs for the hospital. Kun has served as chair of the St. Jude Department of Radiological Sciences and will remain in that position.

Kun joined St. Jude in 1984 to establish a department to treat cancer with radiation therapy and to initiate the multidisciplinary brain tumor program.

Under his leadership, the department grew into the largest pediatric brain tumor research program in the country. Kun succeeds Joseph Laver, who has accepted a position at Stony Brook University Hospital in New York.

Until recently, Kun was chair of the NCI Pediatric Brain Tumor Consortium and has held leadership positions in the Pediatric Oncology Group, the Children’s Oncology Group, the American Society for Radiation Oncology, the Society for Neuro-Oncology, and the American Board of Radiology. He is a founding member of the Alliance for Childhood Cancer.

Kun was awarded the Gold Medal from ASTRO, the Pediatric Oncology Award from the American Society of Clinical Oncology, the Janeway Medal from the American Radium Society, and the Pioneer Award from the Children’s Brain Tumor Foundation.


PAULA RIEGER
, chief executive officer of the Oncology Nursing Society, announced that she plans to retire May 16, 2014.

“It was a personal decision to step away from full-time employment to spend more time with her family,” said a statement released by the society.

Under Rieger’s seven-year tenure as CEO, ONS completed the development, testing, and validation of quality measures funded by the Breast Cancer Fund of the National Philathropic Trust through the ONS Foundation.

ONS achieved the CEO Gold Standard Seal in 2008 and has been reaccredited in subsequent years. In 2013, ONS won the Alfred P. Sloan Award for Excellence in Workplace Effectiveness and Flexibility.

“Paula as done a remarkable job of leading our organization for the past seven years,” said ONS President Mary Gullatte. “Her loyalty, commitment, and dedication to ONS is greatly appreciated and will be truly missed.”


THE OHIO STATE UNIVERSITY
signed an agreement with Microlin Bio Inc. to license a portfolio of Ohio State’s cancer discoveries, including nearly 100 issued and pending microRNA patents in prostate, ovarian, colon and lung cancers.

Additionally, Microlin has licensed a novel nucleic acid delivery technology to deliver these therapies to cancer cells, and Ohio State will have an equity position in Microlin. Microlin plans to build a development facility in Ohio.

These patents were developed by university researchers Carlo Croce and Robert Lee, and with collaborators from NCI and NIH. Croce first linked microRNAs to cancer over 10 years ago. MicroRNAs are now known to play a pivotal role in the growth and spread of many kinds of cancer.

Lee invented methods to deliver the microRNA to the target of interest with minimal degradation, prolonging stability of the molecules, which is an historical challenge in the field of microRNA therapy.

“Nanoparticles can improve the pharmacokinetic properties of oligonucleotides, including microRNAs, and help them get into the tumor and then into the target cell,” says Lee. “My lab in the College of Pharmacy has designed proprietary formulations of lipid nanoparticles that can enhance the clinical performance of miR-based therapeutics by improving their delivery.”


ANAND JILLELLA
joined Emory University as a professor in the Division of Hematology and Medical Oncology and as associate director of community outreach in the Winship Cancer Institute.

Jillella served as the section chief of hematology/oncology and bone marrow transplantation at Georgia Regents University.

His primary clinical interest is bone marrow transplantation, with specific focus in leukemia, multiple myeloma, acute promyelocytic leukemia and other blood-related cancers.

He served as the acting director of the cancer clinical research unit and principal investigator of the Minority-Based Community Clinical Oncology Program supported by NCI and based at GRU.

FDA News

FDA approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia.

Gazyva, also known as GA101, helps certain cells in the immune system attack cancer cells. Gazyva is intended to be used with chlorambucil. 

Gazyva is the first drug with breakthrough therapy designation to receive FDA approval. FDA had also granted Gazyva priority review as well as an orphan product designation.

“This approval reflects the promise of the Breakthrough Therapy Designation program, allowing us to work collaboratively with companies to expedite the development, review and availability of important new drugs,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research.

Gazyva’s approval for CLL is based on a study of 356 participants in a randomized, open-label trial comparing Gazyva in combination with chlorambucil to chlorambucil alone in participants with previously untreated CLL. Participants receiving Gazyva in combination with chlorambucil demonstrated a significant improvement in progression free survival: an average of 23 months compared with 11.1 months with chlorambucil alone.

The most common side effects observed in participants receiving Gazyva in combination with chlorambucil were infusion-related reactions, neutropenia, thrombocytopenia, anemia, musculoskeletal pain, and fever. 

Gazyva is being approved with a boxed warning regarding Hepatitis B virus reactivation and a rare disorder that damages the material that covers and protects nerves in the white matter of the brain, or progressive multifocal leukoencephalopathy. These are known risks with other monoclonal antibodies in this class and rare cases were identified in participants on other trials of Gazyva. 

Gazyva is marketed by Genentech, a member of the Roche Group.


FDA requested that the manufacturer of the leukemia chemotherapy drug Iclusig (ponatinib) suspend marketing and sales of the drug,
because of the risk of life-threatening blood clots and severe narrowing of blood vessels.

The agency recommends that patients currently taking Iclusig who are not responding to the drug should immediately discontinue treatment and discuss alternative treatment options with their health care professionals.

The manufacturer, Ariad Pharmaceuticals, has agreed to suspend marketing and sales of Iclusig while FDA evaluates the safety of the drug.

The agency also recommended that patients who are currently taking Iclusig and responding to the drug, and whose health care professionals determine that the potential benefits outweigh the risks, be treated under a single-patient Investigational New Drug application or expanded access registry program while FDA’s safety investigation continues.

FDA plans to work with the manufacturer on a plan to quickly transition these patients to a program that will allow access under an IND or expanded access registry program, according to a statement from the agency. 

“Health care professionals should not start treating new patients with Iclusig unless no other treatment options are available and all other available therapies have failed,” said the FDA statement.  

The agency’s recent investigation of Iclusig revealed an increased frequency of blood clots and narrowing of blood vessels since the drug was approved in December 2012. 

Currently, approximately 24 percent of patients in a phase II clinical trial, with a median treatment duration of 1.3 years, and approximately 48 percent of patients in the phase I clinical trial, with a median treatment duration 2.7 years, have experienced serious adverse vascular events, including fatal and life-threatening heart attack, stroke, loss of blood flow to the extremities resulting in tissue death, and severe narrowing of blood vessels in the extremities, heart, and brain requiring urgent surgical procedures to restore blood flow. 

In some patients, fatal and serious adverse events have occurred as early as two weeks after beginning Iclusig therapy. 

The clinical trials did not include a control group so it is not possible to determine the relationship of these adverse events to Iclusig, however the increasing rate and pattern of the events strongly suggests that many are drug-related, said the FDA statement. At this time, FDA cannot identify a safe dose level or exposure duration.

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