Bris­tol-My­ers Squib­b's Op­di­vo/Yer­voy com­bo scores col­orec­tal can­cer OK; For­mer Ake­bia, Mer­ri­mack staffers found guilty

→ Bol­stered by pri­or­i­ty re­view and a break­through ther­a­py des­ig­na­tion, Bris­tol-My­ers Squibb’s Op­di­vo/Yer­voy has been ap­proved for a sub­set of col­orec­tal can­cer pa­tients who’ve run out of op­tions. The FDA gave the green light — cov­er­ing mi­crosatel­lite in­sta­bil­i­ty high (MSI-H) or mis­match re­pair de­fi­cient (dMMR) metasta­t­ic col­orec­tal can­cer (mCRC) that has pro­gressed fol­low­ing treat­ment with a flu­o­ropy­rim­i­dine, ox­ali­platin and irinote­can com­bo — based on an on­go­ing Phase II tri­al. Eighty two out of 119 pa­tients re­ceived treat­ment pri­or to the Check­mate-142 study; 46% in that sub-pop­u­la­tion, and 49% over­all, re­spond­ed to the I/O com­bo. Se­ri­ous ad­verse re­ac­tions oc­curred in 47% of all pa­tients — some­what re­flect­ed in the list of safe­ty warn­ings that come with the ap­proval. The rec­om­mend­ed dos­ing sched­ule in­volves an IV in­fu­sion every three weeks for four dos­es, fol­lowed by Op­di­vo main­te­nance ther­a­py.

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