Hunt­ing a full OK for Baven­cio in front­line blad­der can­cer, Pfiz­er, Mer­ck KGaA re­ceive VIP treat­ment at FDA

The JAVELIN Blad­der 100 study was one of the rare bright spots in Baven­cio’s check­ered de­vel­op­ment record. Now Pfiz­er and Mer­ck KGaA get to bur­nish that with a break­through ther­a­py des­ig­na­tion for first-line main­te­nance treat­ment of lo­cal­ly ad­vanced or metasta­t­ic urothe­lial car­ci­no­ma.

The part­ners have sub­mit­ted their sBLA, which is now be­ing re­viewed on a re­al-time ba­sis. Un­der that pi­lot pro­gram — which be­gan in late 2018 — reg­u­la­tors could ac­cess da­ta pri­or to the of­fi­cial ap­pli­ca­tion fil­ing.

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