The class of therapies have been plagued by safety setbacks, prompting their makers to limit their use in ovarian cancer patients, after clinical data suggested patients do not live as long as those given chemotherapy, in 'later-line settings', that is patients who initially have been treated with other drugs.the use of Zejula in certain ovarian cancer patients who had previously undergone three or more chemotherapy regimens.
Soon after, it emerged that FDA advisors in November were set to review whether the use of Zejula in the second-line setting was warranted, given the emergence of additional survival data from a key study.
About 25% of U.S. sales for Zejula emanated from the second-line indication - before the imposition of this latest restriction - a GSK spokesperson told Reuters, adding there is no change to Zejula's second-line indication outside the United States.