Brigham & Women's Suspends Controversial Morcellation Study As Apparent "Difference of Opinion" with FDA Comes to Light

The Brigham & Women’s Hospital has halted a controversial study that combined power morcellators with “containment bags” intended to capture tissue during minimally invasive gynecological surgery.

Launched earlier this summer, the study was designed to enroll 400 women to test dye leakage in several commercially available bags that have not been cleared by FDA for use with power morcellators.

Linda Weiss, director of NCI Office of Cancer Centers, to Retire in March 2015

Linda Weiss said she intends to retire from her job as director of the NCI Office of Cancer Centers.

Weiss’s retirement was announced in an email from NCI Director Harold Varmus Nov. 25.

Orlando Health is choosing a partnership over an affiliation, said Mark Roh, president of the Florida cancer center that’s ending its relationship with MD Anderson Cancer Center. Instead, Roh’s hospital is joining the University of Florida to create the UF Health Cancer Center at Orlando Health.

Ludwig Cancer Research donated a total of $540 million to six of its centers, located at institutions across the country.

AVEO Oncology said that data from a planned interim analysis of the phase II BATON (Biomarker Assessment of Tivozanib in ONcology) study in patients with colorectal cancer indicate that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population. 

The U.S. Preventive Services Task Force released its final recommendation statement on screening for lung cancer with low-dose computed tomography.

Declines in death rates over past two decades have added up to a 20 percent drop in the overall risk of dying from cancer, according to the American Cancer Society’s annual statistics report.

• Gary Lyman to co-direct Fred Hutch outcomes research

• Gary Schwartz named chief of NewYork-Presbyterian/Columbia University Medical Center Division of Hematology/Oncology 

• Richard Gannotta named president of Northwestern Memorial Hospital

• NCI Director Harold Varmus wins Medal of Honour from International Agency for Research on Cancer

• Accelerated Approval granted for Mekinist-Taflinar combination

• European Commission amends Erbitux label

• FDA and EMA launch joint initiative for generics inspections

Death rates continued to decline for all cancers combined for men and women of all major racial and ethnic groups and for most major cancer sites, according to the Annual Report to the Nation on the Status of Cancer. Rates for both sexes combined decreased by 1.5 percent per year from 2001 through 2010.

Janet Rowley, a pioneer in connecting the development of cancer with genetic abnormalities, died from complications of ovarian cancer on Dec. 17 at her home. She was 88.

• Julie Vose Elected President of ASCO

• 2014 Breakthrough Prize Winners Announced

• Andrea Sloan, Prominent Ovarian Cancer Patient Dies

A group of members of both chambers of Congress is urging NCI to increase funding for research in gastric cancers—the latest in a string of advocacy initiatives to carve out fiscal support for specific diseases.

• Lenora Johnson to leave NCI Office of Communications

• Adrienne Lang steps down as VP for executive operations at MD Anderson Cancer Center

• Michael Foley selected to lead the Tri-Institutional Therapeutics Discovery Institute Inc.

• Beti Thompson to present AACR Distinguished Lecture on Cancer Health Disparities

• Supplemental new drug application for Nexavar tablets (sorafenib) approved

• 510(k) clearance granted to an estrogen receptor image analysis and digital read application for breast cancer

• Aptima HPV 16 18/45 genotype assay approved

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

• FDA and the European Medicines Agency grant orphan drug designation to IMAB362

Moves Forward With Approval From BSA

As NCI digs out after the two-week shutdown of the federal government, its leadership has to contend with the prospect of another shutdown weeks away, which may kick in after the current continuing resolution expires Jan. 15, 2014.

Piotr Kulesza, a pathologist at Northwestern University Robert H. Lurie Cancer Center, who worked with the ECOG-ACRIN Cancer Research Group, died after a fall from a hotel balcony after attending the cooperative group’s semi-annual meeting. Kulesza was 46.

In Brief

• Abernethy to Lead CancerLinQ Advisory Committee

• Peter Dottino named director of the Division of Gynecologic Oncology at the Mount Sinai Health System

• Giuseppe del Priore named national director of gynecologic oncology of Cancer Treatment Centers of America.

• Roche announces the three winners of its first Pharma Research & Development Oncology Awards

• The LUNGevity Foundation issues requests for applications for translational research in lung cancer for its 2014 Career Development Awards, Early Detection Awards, and Targeted Therapeutics Awards.

As NCI digs out after the two-week shutdown of the federal government, its leadership has to contend with the prospect of another shutdown weeks away, which may kick in after the current continuing resolution expires Jan. 15, 2014.

FDA granted an accelerated approval to Imbruvica (ibrutinib) for mantle cell lymphoma patients who have received at least one prior therapy. 

Imbruvica was approved four months after submission of its New Drug Application. The agent is sponsored by Pharmacyclics Inc.

More than 230,000 people—including 82 Texas state lawmakers—petitioned BioMarin Pharmaceutical Inc. to provide its investigational drug to an Austin attorney afflicted with stage IIIC ovarian cancer.

• Lynne Penberthy named NCI DCCPS associate director for surveillance

• Michele Bloch appointed chief of NCI Tobacco Control Research Branch

• MD Anderson's James Allison named 2013 Innovations Award winner in Bioscience by The Economist

• European Commission approves Yervoy for first-line treatment of adult unresectable or metastatic melanoma

• FDA approves generic Morphine Sulfate Injection

Conversation with The Cancer Letter: Steven Rosen

Robert Stone, president and incoming CEO of City of Hope, described the evolution of the novel leadership structure at his institution.

While most directors of cancer centers have to fulfill a multitude of very different roles, City of Hope has redistributed these roles, creating the role of provost and chief scientific officer to shape and direct the scientific and educational activities at the institution.

The role encompasses all units of City of Hope: the Comprehensive Cancer Center, the Beckman Research Institute of City of Hope, a National Medical Center, a Medical Foundation, a graduate school for biological sciences, and nationwide philanthropy.

Patients receiving chemotherapy in hospital outpatient departments face up to 47 percent higher costs compared to patients treated in physician community cancer clinics, according to a report prepared by The Moran Company and released by The US Oncology Network and the Community Oncology Alliance.

• Larry Kun Named Clinical Director at St. Jude

• Paula Rieger, CEO of the Oncology Nursing Society, announces plans to retire

• FDA Approves Gazyva in CLL, The Agency's First Approval of a Breakthrough Therapy

• FDA Requests Manufacturer Suspend Sales and Marketing of Iclusig