A US Food and Drug Administration advisory committee declined to back approval of Eli Lilly’s Gemzar as a treatment for ovarian cancer yesterday, saying the data submitted by the company were not robust enough.
The Oncologic Drugs Advisory Committee voted nine to two – with one abstention – against expanding the labelling of Gemzar (gemcitabine) to include recurrent ovarian cancer, because while progression-free survival was improved with Gemzar plus carboplatin versus carboplatin alone, there was no difference between the groups in overall survival.
Ahead of the meeting, the FDA published documents saying the 2.8 month improvement in progression-free survival was difficult to justify as the combination treatment had more side effects. The panel was also concerned that Gemzar could be used as a second-line treatment after relapse on platinum therapy in ovarian cancer, while other drugs, notably paclitaxel, have been shown to prolong survival when used alongside carboplatin in these patients.
Gemzar is already approved for pancreatic, breast and non-small cell lung cancers, and brought in sales of $1.3 billion for Lilly last year. But approval in ovarian cancer would give the product an added lift at a time when its growth rate has been slowing down. Lilly told Reuters it had no plans at present to conduct other studies of Gemzar in ovarian cancer, although ongoing studies would continue to their conclusion.
That said, Lilly is firmly focused on extending its oncology franchise, and started Phase III trials of a brain cancer drug enzastaurin, last week. It is also developing its already-marketed mesothelioma treatment Alimta (pemetrexed) for ovarian cancer.
