GlaxoSmithKline's Zejula application accepted by US Food and drug administration
GlaxoSmithKline (GSK) confirmed on Monday Tesaro, its oncology-focused business, submitted a supplemental new drug application to the US Food & Drug Administration for its Zejula cancer treatment.
The application, supports a potential new indication for the treatment of certain advanced ovarian, fallopian tube, or primary peritoneal cancer patients, was granted priority review and has an action date of October 24.
The London-listed company said the treatment has already faced a large multicenter, open-label, single-arm, phase 2 study that evaluated its safety and activity in adult patients who were treated with three or more previous chemotherapy regimens.
Mary Lynne Hedley, president and chief operating officer of Tesaro, said: "The results of the Quadra study demonstrate that Zejula is active as a late-line treatment for patients beyond those with BRCA mutations. With this study, we continue to advance our mission to provide more patients with ovarian cancer an opportunity to benefit from treatment with Zejula."
Ovarian cancer is the fifth most frequent cause of cancer death among women, with 22,000 women diagnosed each year in the United States, and more than 65,000 annually diagnosed in Europe.
Hal Barron, chief scientific officer and president of R&D at GSK, said: "We know Zejula plays an important role in helping women with ovarian cancer whose disease has progressed despite initial therapy. Our hope is that over time, our ongoing clinical trials will demonstrate that this medicine can benefit even more patients."
GlaxoSmithKline's shares were up 1.12% at 1,594.00p at 1613 BST.