FDA delays decision on GSK blood cancer drug at heart of $1.9B Sierra Oncology deal

GSK’s blood can­cer drug mo­melo­tinib has tak­en an­oth­er turn on its wind­ing jour­ney, with the FDA de­lay­ing its re­view of the in­ves­ti­ga­tion­al tablet that GSK picked up in last year’s buy­out of Sier­ra On­col­o­gy by three months.

GSK said Fri­day that the reg­u­la­tor pushed back its de­ci­sion, orig­i­nal­ly slat­ed for June 16, to Sept. 16, to “pro­vide time to re­view re­cent­ly sub­mit­ted da­ta.”

“GSK is con­fi­dent in the mo­melo­tinib NDA and looks for­ward to work­ing with the FDA as they fi­nal­ize their re­view,” the com­pa­ny said in a state­ment.

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