Drugs
-
Oral niraparib, a highly-selective, potent poly(ADP-ribose) polymerase (PARP)-1 and PARP-2 inhibitor, is approved in the USA for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. It is also under regulatory review in the EU for use in maintenance treatment in patients with platinum-sensitive, recurrent epithelial ovarian cancer who are in response to platinum-based chemotherapy. ⋯ Niraparib is also in development for use in other solid tumours, including breast and prostate cancer. This article summarizes the milestones in the development of niraparib leading to its first global approval for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
-
Chronic pruritus remains a central societal issue because of its high occurrence and the substantial decrease in quality of life it may cause to affected individuals. Not only dermatological conditions, but also systemic, neurological, or psychiatric diseases may lead to chronic pruritus. Additionally, various underlying conditions may coexist or the cause may be unknown. ⋯ New insights into pathways involved in the development and maintenance of chronic pruritus have led in the past years to the development of a considerable number of novel antipruritic drugs. Several randomized controlled trials have been recently completed or are currently underway testing biological compounds with promising approaches. These include antagonists for nerve growth factor, neuropeptides, histamine 4 receptors, certain interleukin receptors, and opioid receptors.
-
Eluxadoline (Truberzi®) is an orally administered, minimally absorbed agent that acts locally in the gastrointestinal tract as a mixed µ-opioid receptor agonist and δ-opioid receptor antagonist. The randomized, double-blind, placebo-controlled, multinational, phase 3 IBS-3001 and IBS-3002 trials examined the efficacy of eluxadoline in patients with diarrhoea-predominant irritable bowel syndrome (IBS-D). The composite response rate (i.e. the proportion of patients with improvement in both worst abdominal pain and stool consistency on ≥50% of days; primary endpoint), was significantly higher in patients receiving eluxadoline 100 mg twice daily than in those receiving placebo after 12 and 26 weeks' therapy. ⋯ Constipation was the most commonly occurring adverse event, although no serious constipation events were reported. Pancreatitis and adverse events consistent with sphincter of Oddi spasm were uncommon. In conclusion, eluxadoline is a new option to consider in the treatment of adult patients with IBS-D.
-
Four medicinal cancer biological blockbusters will end their patent lifespan by 2020. It is estimated that the total market for cancer biologicals will reach approximately US$68 billion at that time. Approximately 20 biosimilars have entered the European market since the launch of the original approval guidelines in 2005, and four biosimilars have been approved in the USA since 2015. ⋯ High expectations are being placed on the cost savings, safety, and efficacy of these products. The entry costs for biosimilars and the pricing reaction of their originator products will determine the true savings by troubled health systems in dire need of cost cuts. This article discusses basic principles of biosimilars in hematology and oncology, the current status of their clinical development, and trends of acceptance by healthcare providers, and provides insight into potential future challenges.