The lancet oncology
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The lancet oncology · Dec 2014
ReviewInfection control issues in patients with haematological malignancies in the era of multidrug-resistant bacteria.
Drug-resistant Gram-negative and Gram-positive bacteria are now increasingly identified as a cause of infections in immunocompromised hosts. Bacteria identified include the multidrug-resistant (MDR) and even pandrug-resistant Acinetobacter baumannii and Pseudomonas aeruginosa, as well as carbapenem-resistant Enterobacteriaceae spp. The threat from MDR pathogens has been well-documented in the past decade with warnings about the consequences of inappropriate use of antimicrobial drugs. ⋯ Inappropriate antimicrobial treatment can affect morbidity, mortality, and overall health-care costs. Evidence-based data for prevention and control of MDR pathogen infections in haematology are scarce. Although not yet established a bundle of infection control and prevention measures with an anti-infective stewardship programme is an important strategy in infection control, diagnosis, and antibiotic selection with optimum regimens to ensure a successful outcome for patients.
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The lancet oncology · Dec 2014
ReviewRegulatory and clinical considerations for biosimilar oncology drugs.
Biological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents-molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs-provide opportunities both to improve health-care access and outcomes, and to reduce costs. Several international regulatory pathways have been developed to expedite entry of biosimilars into global marketplaces. ⋯ Oncology biosimilars are now widely marketed in several countries in Europe, and in Australia, Japan, China, Russia, India, and South Korea. Their use is emerging worldwide, with the notable exception of the USA, where several regulatory and cost barriers to biosimilar approval exist. In this Review, we discuss oncology biosimilars and summarise their regulatory frameworks, clinical experiences, and safety concerns.