@article{SanMiguelEinseleMoreau2016, author = {San-Miguel, Jesus F. and Einsele, Hermann and Moreau, Philippe}, title = {The Role of Panobinostat Plus Bortezomib and Dexamethasone in Treating Relapsed or Relapsed and Refractory Multiple Myeloma: A European Perspective}, series = {Advances in Therapy}, volume = {33}, journal = {Advances in Therapy}, number = {11}, doi = {10.1007/s12325-016-0413-7}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-186840}, pages = {1896-1920}, year = {2016}, abstract = {Panobinostat is an oral pan-histone deacetylase inhibitor developed by Novartis. Panobinostat acts via epigenetic modification and inhibition of the aggresome pathway. In August 2015, the European Commission authorized panobinostat for use in combination with bortezomib and dexamethasone for the treatment of relapsed or relapsed and refractory multiple myeloma (MM) in patients who have received aeyen2 prior regimens including bortezomib and an immunomodulatory drug. In January 2016, the National Institute for Health and Care Excellence recommended panobinostat for use in the same combination and patient population. The authorization and recommendation were based on results from the pivotal phase 3 PANORAMA 1 (NCT01023308) clinical trial, which demonstrated an improvement in median progression-free survival of 7.8 months for the three-drug combination compared with placebo plus bortezomib and dexamethasone in this patient population. This review will discuss the current treatment landscape for relapsed/refractory MM, the mechanism of action of panobinostat, clinical data supporting the European authorization, concerns about safety and strategies for mitigating toxicity, and how panobinostat fits into the current MM landscape in Europe.}, language = {en} } @article{LudwigDelforgeFaconetal.2018, author = {Ludwig, Heinz and Delforge, Michel and Facon, Thierry and Einsele, Hermann and Gay, Francesca and Moreau, Philippe and Avet-Loiseau, Herv{\´e} and Boccadoro, Mario and Hajek, Roman and Mohty, Mohamad and Cavo, Michele and Dimopoulos, Meletios A and San-Miguel, Jes{\´u}s F and Terpos, Evangelos and Zweegman, Sonja and Garderet, Laurent and Mateos, Mar{\´i}a-Victoria and Cook, Gordon and Leleu, Xavier and Goldschmidt, Hartmut and Jackson, Graham and Kaiser, Martin and Weisel, Katja and van de Donk, Niels W. C. J. and Waage, Anders and Beksac, Meral and Mellqvist, Ulf H. and Engelhardt, Monika and Caers, Jo and Driessen, Christoph and Blad{\´e}, Joan and Sonneveld, Pieter}, title = {Prevention and management of adverse events of novel agents in multiple myeloma: a consensus of the European Myeloma Network}, series = {Leukemia}, volume = {32}, journal = {Leukemia}, doi = {10.1038/s41375-018-0040-1}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:20-opus-237338}, pages = {1542-1560}, year = {2018}, abstract = {During the last few years, several new drugs have been introduced for treatment of patients with multiple myeloma, which have significantly improved the treatment outcome. All of these novel substances differ at least in part in their mode of action from similar drugs of the same drug class, or are representatives of new drug classes, and as such present with very specific side effect profiles. In this review, we summarize these adverse events, provide information on their prevention, and give practical guidance for monitoring of patients and for management of adverse events.}, language = {en} }