ODAC Declines to Recommend Approval of Eloxatin
April 1st 2000BETHESDA, Md-The Oncologic Drugs Advisory Committee (ODAC) declined to vote on whether to recommend that the Food and Drug Administration approve Eloxatin (oxaliplatin, Sanofi Pharmaceuticals) for the first-line treatment of patients with advanced colorectal cancer in combination with fluorouracil (5-FU)-based chemotherapy.
Rituximab Is Well Tolerated When Preceded by Chemo
April 1st 2000NEW ORLEANS-Toxicity related to rituximab (Rituxan) is greatly reduced in patients with indolent lymphomas when the antibody is given after two cycles of mitoxantrone/cyclophosphamide chemotherapy, Christos Emmanouilides, MD, reported in a poster presentation at the 41st annual meeting of the American Society of Hematology (ASH).
ODAC Subcommittee Assessing Problems in Quality-of-Life Studies of Cancer Drugs
April 1st 2000BETHESDA, Md-At the request of the Food and Drug Administration, a special subcommittee of the Oncologic Drugs Advisory Committee (ODAC) has begun assessing issues related to the use of quality-of-life (QOL) endpoints in the approval process for new oncology drugs.
NCPB Urges States to Step Up Tobacco Control Programs
April 1st 2000WASHINGTON-The National Cancer Policy Board (NCPB) has a message for states still deciding whether to devote some or all of their tobacco settlement funds to lowering tobacco use: Aggressive, focused control efforts work and save lives. “As states contemplate increasing their tobacco control efforts, many have asked if such programs can make a difference. The evidence is clear: They can,” a new NCPB report says.
FDA Tries to ‘Jump Start’ Pediatric Cancer Drug Trials
April 1st 2000ROCKVILLE, Md-A new initiative by the Food and Drug Administration seeks to move more oncology drugs into pediatric testing and onto the market. In a letter sent to drug companies and researchers, and made public, the FDA said that such an effort “merits special consideration” and notes that the “known and potential differences in the biology of pediatric and adult tumors usually will not permit the extrapolation of clinical activity from adults to children.”
Sedation in the Imminently Dying Patient
April 1st 2000Over the past decade, increased attention has focused on the care of dying patients. The role of the physician in caring for these patients has been the subject of renewed interest and intense, sometimes passionate, debate. Patient groups have formed to advocate for the promotion of compassion in the care of the dying, and some of these advocacy groups have asserted a fundamental “right” to physician-assisted suicide. The US Supreme Court has ruled against a constitutional right to physician-assisted suicide but has asserted its willingness to reconsider the issue if it learned that dying patients were not receiving appropriate, high-quality end-of-life care.[1]
IOM Medical Error Estimates Questioned, But Legislation Considered
March 1st 2000When Janet Woodcock, MD, a top FDA official, appeared before a Senate committee in early February, she tried to put the issue of medical errors in perspective by referring to a patient who dies after chemotherapy. She rhetorically asked whether
Rituximab Has Significant Activity in Patients With Chronic Lymphocytic Leukemia
March 1st 2000Rituximab (Rituxan) is a chimeric monoclonal antibody binding to CD20. A multicenter trial in relapsed low-grade lymphoma (375 mg/m²/wk × 4) produced a response rate of 48%. However, patients with small lymphocytic lymphoma
PhRMA Criticizes FDA’s Proposed Rule on Antibiotic Approvals
March 1st 2000Due to the growing problem of antibiotic resistance, physicians have been clamoring for new drug companies to ratchet up antibiotic research and development. Congress had the same concern when it passed the FDA Modernization Act in 1997,
Coaxial Breast Biopsy Device Provides Diagnostic Specimens
March 1st 2000CHICAGO-A simple coaxial breast biopsy tool that can be guided by mammography provides a larger tissue specimen than standard core needle biopsies, causes less bleeding and scarring than surgical biopsy, and carries a smaller price than stereotactically guided biopsy procedures, according to Lincoln Russin, MD, who devised the new biopsy tool. Dr. Russin is a radiologist at Noble Hospital, Westfield, Massachusetts, and associate clinical professor of radiology, Yale University.
3D Digital Camera Accurately Calculates Breast Shape, Volume
March 1st 2000NEW ORLEANS-A novel imaging system-consisting of a three-dimensional digital camera mounted on a tripod, an LCD display monitor, and a standard desktop computer (see Figure 1)-may be the harbinger of the future of breast surgery,
New Antibiotic Effective in Treating Gram-Positive Bacteremia
March 1st 2000Results from the compassionate use program for linezolid (Zyvox), an investigational new antibiotic still under development, show that the drug is effective in the treatment of patients with bacteremia associated with significant gram-positive infections,
Rituximab/CHOP Induction Therapy in Newly Diagnosed Patients With Mantle Cell Lymphoma
March 1st 2000Mantle cell lymphoma (MCL) is a recently identified, aggressive, B-cell neoplasm that is incurable with current combination chemotherapy regimens. Novel therapeutic strategies are needed. MCLs express high levels of cell-surface CD20 and are
State of the Union on Youth Smoking ‘Clearly Not Good’
March 1st 2000WASHINGTON-The most comprehensive survey of tobacco use among young people has found that 12.8% of middle school students and 34.8% of those in high school reported using some form of tobacco product in the month prior to answering a questionnaire. Cigarettes were favored by most of the students, with cigars second.
In Vivo Purging With Rituximab During Stem Cell Transplantation for Indolent Lymphoma
March 1st 2000Autologous peripheral blood stem-cell (PBSC) transplantation may play an important role in the treatment of indolent lymphomas, as well as aggressive lymphomas. Concern about the contamination of the autologous graft with lymphoma
ASCO Launches Large-Scale Study on Quality of Cancer Care
March 1st 2000ALEXANDRIA, Virginia-The American Society of Clinical Oncology (ASCO) has launched the first study aimed at developing a national monitoring system for cancer care in the United States. A panel of ASCO physicians and other health experts will oversee the study, which will be conducted by researchers at Harvard University and the RAND Corporation, the organization said in a news release.