Immediate interaction with US FDA after stressful advisory committee facilitated accelerated approval in fourth-line myeloma, company says. Four different dosing regimens will be priced at $22,000 for four weeks.
Karyopharm Therapeutics Inc. obtained approval for Xpovio (selinexor) to treat penta-refractory multiple myeloma patients on 3 July, with a full approval hinged on the ongoing Phase III BOSTON trial, despite safety concerns and other issues overhanging the drug.
Pessimism reigned regarding the chances for the first-in-class nuclear export inhibitor to gain accelerated approval following a US FDA advisory committee review in February, but
Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a 232 investigation.
The US FDA has ordered compounders of the Danish firm's obesity drug semaglutide to shut up shop later this month, but competition from Eli Lilly is only increasing.
The weak US dollar helped some companies reporting first-quarter results and hindered others reporting in stronger currencies. But even the impacts of currencies and Medicare modernization on first-quarter revenues were overlooked when an end to the trade wars seemed possible.
