Break­through sta­tus and promise of a speedy re­view ar­rives for Op­di­vo/Yer­voy com­bi­na­tion as Bris­tol-My­ers bites at Bay­er

Its front­line and sin­gle-agent as­pi­ra­tions have been set back, but Bris­tol-My­ers Squibb just took a big step for­ward in its ef­forts to ap­ply its check­point in­hibitor Op­di­vo to liv­er can­cer. The FDA has grant­ed break­through sta­tus and pri­or­i­ty re­view to a com­bi­na­tion, sec­ond-line treat­ment.

The des­ig­na­tion is for Op­di­vo (nivolum­ab) in com­bi­na­tion with Yer­voy (ip­il­i­mum­ab),  for treat­ing ad­vanced he­pa­to­cel­lu­lar car­ci­no­ma (HCC), the most com­mon form of liv­er can­cer. The PD-L1 drug was al­ready ap­proved as a sin­gle-agent, sec­ond-line treat­ment for HCC. A PDU­FA date was set for March 10, 2020 — just 4 months from now.

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