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BETHESDA, Md-Pharmacia & Upjohn’s Camptosar (irinotecan hydrochloride injection) found smooth sailing through the often roiling waters of the FDA’s Oncologic Drugs Advisory Committee (ODAC).
WASHINGTON-The Food and Drug Administration’s effort to prod pharmaceutical companies into earlier testing of anticancer agents in children and teens (see FDA Tries to ‘Jump Start’ Pediatric Cancer Drug Trials) has drawn rave reviews from the pediatric oncology community.
BETHESDA, Md-In an unusual decision, the FDA’s Oncologic Drugs Advisory Committee (ODAC) first voted against recommending accelerated approval for Mylotarg (gemtuzumab ozogamicin, Wyeth-Ayerst) for the treatment of patients with CD33-positive acute myeloid leukemia (AML) in relapse. Then, after a sometimes intense discussion, ODAC members urged the FDA to grant accelerated approval for the drug’s use in a limited subgroup of patients, particularly those older than age 60.
NEW YORK-Cancer patients have employment rights under the Americans With Disabilities Act (ADA) and other legislation, “and they will need them,” L. Susan Scelzo Slavin, Esq, a nationally known advocate and litigator on behalf of the catastrophically ill, said at a workshop sponsored by Cancer Care, Inc.
Researchers at the National Cancer Institute (NCI) have reported an antitumor effect in a small group of patients with lymphoma who were vaccinated with an experimental B-cell lymphoma vaccine over a 5-year period. These promising
NEW YORK- Three researchers at the Chemotherapy Foundation Symposium XVII reported efforts to improve survival in the brain cancers glioblastoma multiforme and astrocytoma with new chemotherapeutic combinations.
BETHESDA, Md-The National Cancer Advisory Board (NCAB) has objected in a letter to several proposed provisions in a new rule mandated by Congress and drafted by the Department of Health and Human Services (HSS). The regulation would set privacy standards governing the release of health information that might reveal the identity of individual patients, and it could significantly affect oncologists whose patients enter clinical trials.
NEW ORLEANS-Primarily used for preprocedural analgesia and sedation in children, oral transmucosal fentanyl citrate (Actiq) also works well for adult cancer patients undergoing diagnostic bone marrow aspiration and biopsy, Cheryl Ann Arena, MPH, PA–C, said at her poster presentation at the American Society of Hematology annual meeting.
The Charter of Paris Against Cancer was signed by more than 100 international leaders in government, patient advocacy, cancer
BETHESDA, 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.
NEW 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).
BETHESDA, 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.
WASHINGTON-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.
ROCKVILLE, 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 is a clinically important therapeutic intervention in the imminently dying patient. As the patient with an advanced, irreversible illness nears the end of life, symptoms accumulate that are progressively more difficult to
Over 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]
Local tumor recurrence after radiation therapy is due primarily to the failure to eradicate all of the tumor cells within the treatment fields. Theoretically, all cancers could be controlled locally if a sufficiently high radiation dose
An innovative approach to treating glioblastoma multiforme-the use of a bacterial toxin attached to interleukin-13 (IL-13)-has been tested in animals, and a phase I study
In 1998, a retrospective cost-minimization analysis from the perspective of a British hospital was performed comparing the use of cyclophosphamide, doxorubicin, Oncovin, and prednisolone (CHOP), fludarabine (FLU [Fludara]), and rituximab
Among patients with low-grade non-Hodgkin’s lymphoma (NHL), combining CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy with rituximab (Rituxan) adds therapeutic benefit
This phase II trial investigated the safety and efficacy of retreatment with rituximab (Rituxan) in patients with low-grade or follicular non-Hodgkin’s lymphoma who relapsed following a response to rituximab therapy.
Ibritumomab tiuxetan (IDEC-Y2B8 [Zevalin]) is an anti-CD20 murine immunoglobulin G1 (IgG1) kappa monoclonal antibody conjugated to tiuxetan (MXDTPA), which can securely chelate either indium-111 (111In) for imaging/dosimetry or yttrium-90 (90Y) for therapy.
When 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
Transformation of low-grade non-Hodgkin’s lymphoma (NHL) to a more aggressive histology is associated with a very poor response to chemotherapy and shortened survival. Therefore, new therapeutic agents are needed. Tositumomab/iodine-
Rituximab (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
Rituximab (Rituxan) has mechanisms of antilymphoma action that differ significantly from those of chemotherapeutic agents: both direct (induction of apoptosis and chemosensitization) and indirect (complement-dependent cytotoxicity and antibody
Due 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,
The rationale for combining rituximab (Rituxan), a chimeric anti-CD20 monoclonal antibody, with chemotherapy includes single-agent efficacy, non–cross-resistant mechanisms of action, possible synergy, and few overlapping toxicities. The safety
CHICAGO-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.
NEW 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,