On August 5, 2013, a marketing authorization valid throughout the European Union (EU) was issued for pomalidomide in combination with dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. Pomalidomide is an immunomodulating agent. The recommended starting dose of pomalidomide is 4 mg once daily taken on days 1-21 of repeated 28-day cycles. The main evidence of efficacy for pomalidomide in MM was based on a phase III multicenter, randomized, open-label study (CC-4047-MM-003) in which pomalidomide plus low-dose dexamethasone therapy (POM+LoDEX) was compared with high-dose dexamethasone alone (HiDEX) in previously treated adult patients with relapsed and refractory multiple myeloma who had received at least two prior treatment regimens, including both lenalidomide and bortezomib, and had demonstrated disease progression on the last therapy. For the intent-to-treat population, median progression-free survival based on International Myeloma Working Group criteria was weeks (95% confidence interval [CI]: -) in the POM+LoDEX group versus weeks (95% CI: -) in the HiDEX group (log-rank p value <.001). Overall survival (secondary endpoint) was also different in the two treatment groups (hazard ratio [95% CI: -]). The most commonly reported adverse reactions to pomalidomide in clinical studies were anemia (%), neutropenia (%) and thrombocytopenia (27%), fatigue (%), pyrexia (21%), peripheral edema (13%), and infections including pneumonia (%). Peripheral neuropathy adverse reactions were reported in % of patients, and venous embolic or thrombotic (VTE) adverse reactions were reported in % of patients. Pomalidomide is expected to be teratogenic. This paper summarizes the scientific review of the application leading to approval in the EU. The detailed scientific assessment report and product information, including the summary of product characteristics, are available on the EMA website (http://).
A compound found in green tea could improve the cognitive abilities of those with Down’s syndrome, a team of scientists has discovered. Researchers found epigallocatechin gallate – which is especially present in green tea but can also be found in white and black teas – combined with cognitive stimulation, improved visual memory and led to more adaptive behaviour. Dr Rafael de la Torre, who led the year-long clinical trial along with Dr Mara Dierrssen, said: “The results suggest that individuals who received treatment with the green tea compound, together with the cognitive stimulation protocol, had better scores in their cognitive capacities”