FDA has granted priority review for a new supplemental Biologics License Application for Keytruda, which seeks approval of the anti-PD-1 therapy as monotherapy in patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Over the course of his first six months as NCI director, Anthony Letai has contended with federal budget turbulence, a record-setting government shutdown, and concerns about the flow of over research dollars.
