(Alliance News) - GlaxoSmithKline PLC on Monday said Tesaro, its oncology-focused business, submitted a supplemental new drug application to the US Food & Drug Administration for Zejula.
The drugmaker said the application was granted priority review and has an action date of October 24.
"We know Zejula plays an important role in helping women with ovarian cancer whose disease has progressed despite initial therapy," said Hal Barron, chief scientific officer & president at GSK's Research & Development unit.
"Our hope is that over time, our ongoing clinical trials will demonstrate that this medicine can benefit even more patients," added Barron.
GSK shares were trading 0.2% higher on Monday at 1,579.00 pence each in London.