publication date: Dec. 3, 2013

In Brief

LYNNE PENBERTHY was named associate director for surveillance research in NCI’s Division of Cancer Control and Population Sciences.

Penberthy will help advance the Surveillance Research Program’s mission to collect and analyze pertinent data in order to answer key questions about cancer incidence, mortality, prevalence, and survival in diverse regions and populations in the U.S, including through the Surveillance, Epidemiology, and End Results Program.

Prior to her current NCI appointment, she was director of cancer research informatics and services and associate professor of general internal medicine at the Virginia Commonwealth University Massey Cancer Center.

 

MICHELE BLOCH was appointed chief of the Tobacco Control Research Branch, an extramural branch of the NCI.

Bloch joined NCI in 1999 and has helped develop and implement several research initiatives including NCI’s “Review and Analysis of Tobacco Industry Documents,” and the trans-NIH funding opportunity focused on international tobacco research and capacity building led by the Fogarty International Center. She helped develop and implement the NCI Smoke-free Meetings policy, and has also served on numerous committees and workgroups.

Her research interests have included tobacco control policies focused on women and girls, addressing tobacco use in pregnancy, and reducing tobacco use in low- and middle-income countries. Prior to joining NCI, she served as a member of the Maryland State Council on Cancer Control, and chaired the Alcohol, Tobacco and Other Drug Section of the American Public Health Association.

 

JAMES ALLISON was named the 2013 Innovations Award winner in Bioscience by The Economist. Allison is professor and chair of immunology at MD Anderson Cancer Center.

Allison identified an immune checkpoint molecule that turns off T cells before they can mount a successful response to tumors that they are primed to destroy.

An antibody that blocks that immune checkpoint molecule, Yervoy (ipilumumab), became the first drug to ever extend survival for patients with late-stage melanoma. FDA approved Yervoy for treatment of metastatic melanoma in 2011.

The Economist’s Innovation Awards recognize significant contributions in eight fields: Bioscience, Computing and Telecommunications, Consumer Products, Energy and Environment, Process and Services, Social and Economic, No Boundaries, and Corporate.

Allison will receive the award at a ceremony in London on Dec. 3. He is a member of the National Academy of Sciences and the Institute of Medicine of the National Academies.

 

JESUS ESQUIVEL was appointed national director of HIPEC, hyperthermic intraperitoneal chemotherapy, at Cancer Treatment Centers of America. Based out of Eastern Regional Medical Center in Philadelphia, Esquivel will oversee the organization’s national HIPEC research.

He has held positions in the Social Service in Mexico, as attending physician of general and oncology surgery at Kaiser Permanente, and as director of peritoneal surface malignancies at St. Agnes Health Care Hospital.

Additionally, Esquivel has been an assistant professor of gynecologic oncology at Johns Hopkins School of Medicine and an adjunct member of the U.S. Military Cancer Institute.

Esquivel is a Fellow of the American College of Surgeons, a member of the American Society of Clinical Oncology and Society of Surgical Oncology, a member of the International Society of Gastrointestinal Oncology and a member of the American Society of Peritoneal Surface Malignancies.

Drug Approvals

The European Commission approved Yervoy (ipilimumab) for first-line treatment of adult patients with unresectable or metastatic melanoma.

Yervoy was initially approved in Europe in July 2011 for the treatment of adult patients with previously-treated advanced melanoma.

The extension was supported by data from phase II and III studies conducted in advanced melanoma patients, as well as from two retrospective observational studies in first-line advanced melanoma patients who were treated with Yervoy 3 mg/kg monotherapy.

Overall survival of Yervoy 3 mg/kg monotherapy in chemotherapy-naive patients pooled across phase II and III clinical trials (n=78; randomized) and in treatment-naïve patients in two retrospective observational studies (n=120 and n=61) were generally consistent.

The estimated one-year survival rates were 59.5 percent (95% CI: 50.1 – 67.8) and 49.3 percent (95% CI: 35.6 – 61.6) in the two retrospective observational studies. The estimated one-year and two-year survival rates for chemotherapy-naive patients (n=78) pooled across phase II and III clinical trials were 54.1 percent (95% CI: 42.5 – 65.6) and 32 percent (95% CI: 20.7 – 42.9), respectively. These observational data were presented at the European Cancer Congress.

This indication extension is applicable to all 28 European Union member states, as well as Iceland and Norway. Yervoy is sponsored by Bristol-Myers Squibb.

 

FDA approved Morphine Sulfate Injection, USP to be offered in the BD Simplist line of ready-to-administer prefilled injectables in the most common strengths: 2, 4, 5, 8, and 10 mg/mL. The injection is indicated for the management of pain not responsive to non-narcotic analgesics.

BD Rx Inc., a subsidiary of Becton, Dickinson and Company, will begin production of morphine and projects initial product availability in early calendar year 2014, according to a statement from the company.

This approval marks the fourth in a series of 20 to 30 drugs that BD Rx plans to launch in the BD Simplist prefilled injectables product line in the coming years. The first three drugs launched in the past year are Diphenhydramine Hydrochloride Injection, USP; Metoclopramide Injection, USP; and Ondansetron Injection, USP.

 

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