FDA re­jects Tesaro’s IV ver­sion of ro­lap­i­tant, cit­ing man­u­fac­tur­ing is­sues

Tesaro’s plans for build­ing up sales of Varu­bi — or ro­lap­i­tant — through a new in­tra­venous for­mu­la­tion of the drug will have to wait. The FDA shot down the biotech’s mar­ket­ing ap­pli­ca­tion, which the biotech says is sole­ly dur­ing to some out­stand­ing man­u­fac­tur­ing is­sues.

The pill ver­sion of the drug — used to treat chemo in­duced nau­sea and vom­it­ing — was OK’d back in 2015, trig­ger­ing a block­buster pro­jec­tion from the com­pa­ny. An­a­lysts, though, have been less than im­pressed with the roll­out, with Leerink pulling back its fore­cast on sales.

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