In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 bil­lion drug ma­grolimab has run in­to a se­ri­ous set­back.

The FDA or­dered Gilead to halt en­roll­ment on their stud­ies of the drug in com­bi­na­tion with azac­i­ti­dine af­ter in­ves­ti­ga­tors re­ports re­vealed an “ap­par­ent im­bal­ance” in the sus­pect­ed un­ex­pect­ed se­ri­ous ad­verse re­ac­tions be­tween study arms. And the halt is rais­ing ques­tions about Gilead’s plans for a quick pitch to reg­u­la­tors.

“While no clear trend in the ad­verse re­ac­tions or new safe­ty sig­nal has been iden­ti­fied by Gilead at this time, the par­tial clin­i­cal hold is be­ing im­ple­ment­ed by Gilead across all on­go­ing ma­grolimab and azac­i­ti­dine (Vi­daza) com­bi­na­tion stud­ies world­wide in the best in­ter­ests of pa­tients as ad­di­tion­al da­ta is gath­ered and an­a­lyzed to ad­dress the con­cerns raised by FDA,” the big biotech said in a state­ment.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER