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The European Medicines Agency Review of Isatuximab in Combination with Pomalidomide and Dexamethasone for the Treatment of Adult Patients with Relapsed and Refractory Multiple Myeloma
Oncologist. 2021 Jul 2. doi: 10.1002/onco.13892. Online ahead of print.ABSTRACTIsatuximab is a monoclonal antibody that binds to the human CD38 antigen. On 30 May 2020, a marketing authorization valid through the European Union (EU) was issued for isatuximab in combination with pomalidomide and dexamethasone (IsaPd) for the treatment of adult patients with relapsed and refractory (RR) multiple myeloma (MM). The recommended dose of isatuximab was 10 mg/kg, administered IV weekly at cycle 1 and then biweekly in subsequent 28-day cycles. Isatuximab was evaluated in a phase 3, open label, multicenter randomized trial that rand...
Source: The Oncologist - July 2, 2021 Category: Cancer & Oncology Authors: Julio Delgado Malgorzata Zienowicz Paula Boudewina van Hennik Alexandre Moreau Christian Gisselbrecht Harald Enzmann Francesco Pignatti Source Type: research

Efficacy and Safety Profile of Diclofenac/Cyclodextrin and Progesterone/Cyclodextrin Formulations: A Review of the Literature Data
Conclusions As shown by the results of clinical studies presented in this review, the newly approved medicines containing cyclodextrins have been found to be as effective and as well-tolerated as other medicinal products that do not contain cyclodextrins. Moreover, the newly approved lower dose of diclofenac associated with cyclodextrins is consistent with the European Medicines Agency recommendations reported in the revision of the Assessment Report for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Cardiovascular Risk. Finally, the use of cyclodextrins led to significant increases in solubility and bioavail...
Source: Drugs in R&D - March 3, 2016 Category: Drugs & Pharmacology Source Type: research