Drugs
-
Avelumab (Bavencio®) is an intravenously administered programmed cell death ligand-1-blocking human antibody initially developed by EMD Serono Inc. (the biopharmaceutical division of Merck KGaA, Darmstadt, Germany) [now jointly developed and commercialized by EMD Serono Inc. and Pfizer] for the treatment of various tumours. It has received accelerated approval in the USA for the treatment of metastatic Merkel cell carcinoma (mMCC) in adults and paediatric patients aged ≥12 years. The marketing authorization application for avelumab in the treatment of mMCC is undergoing regulatory review in the EU, the biologics license application for avelumab in the treatment of urothelial carcinoma is undergoing priority review by the FDA, and avelumab is in various stages of development internationally for a variety of cancers. This article summarizes the milestones in the development of avelumab leading to this first approval for mMCC.
-
Naldemedine (Symproic®) is an orally active µ-opioid receptor antagonist being developed by Shionogi & Co., Ltd. that has been approved in the USA and Japan for the treatment of opioid-induced constipation. The drug inhibits peripheral µ-opioid receptors such as those present in the gastrointestinal tract and has minimal or no effect on central opioid activity. This article summarizes the milestones in the development of naldemedine leading to its first global approval in the USA for the treatment of opioid-induced constipation in patients with chronic non-cancer pain.