Fo­cus­ing on next-gen can­cer drugs, GSK touts a ‘break­through’ at FDA; Ais­ling rais­es $280M fund

→ Any­one look­ing for fresh signs of Glax­o­SmithK­line’s plans to go much deep­er in­to on­col­o­gy should check out the phar­ma gi­ant’s no­tice that its mul­ti­ple myelo­ma drug GSK2857916 just won the FDA’s break­through des­ig­na­tion. GSK’s Ax­el Hoos, who’s been run­ning the ear­ly-stage on­col­o­gy ef­fort af­ter the big as­set swap with No­var­tis, said this drug could be a trans­for­ma­tion­al ther­a­py.  “On­col­o­gy R&D at GSK is fo­cused on de­vel­op­ing med­i­cines with trans­for­ma­tion­al po­ten­tial for pa­tients and we are pleased that our in­ves­ti­ga­tion­al an­ti­body-drug con­ju­gate is the first BC­MA tar­get­ing agent to re­ceive Break­through Ther­a­py and PRIME des­ig­na­tion,” he not­ed. “GSK plans to rapid­ly ad­vance clin­i­cal tri­als with this promis­ing ther­a­py, alone and in com­bi­na­tion with oth­er ther­a­pies, to fur­ther in­ves­ti­gate how GSK2857916 could ben­e­fit pa­tients with mul­ti­ple myelo­ma.”

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