Regulatory Roundup: Priority Review for Xpovio, Tecentriq in new indications; plus CRLs delay Keytruda dosing update

FDA granted Priority Review to supplemental applications for Karyopharm's Xpovio and Roche's Tecentriq, setting June deadlines for decisions that could expand each drug's label.

The agency will consider granting accelerated approval to Xpovio selinexor to treat relapsed or refractory diffuse large B cell lymphoma (DLBCL) in a third-line setting; its PDUFA date is June 23. Xpovio is an oral selective inhibitor of nuclear export protein XPO1...