FDA Priority Review granted for GSKs Zejula

The US Food and Drug Administration (FDA) has accepted Glaxo Smith Klines application for Zejula (niraparib) in late stage ovarian cancer with priority review. The company announced that Tesaro, an oncology-focused business acquired by GSK, submitted a supplemental New Drug Application (sNDA) to the governing body, with an expected action date of 24 October 2019. The sNDA supports a potential new indication for the treatment in advanced ovarian, fallopian tube, or primary peritoneal cancer patients who have been treated with three or more prior chemotherapy regimens. Also, patients whose cancer is associated with eitherBRCA mutation or homologous recombination deficiency (HRD) and who have progressed more than six months after the last platinum-based chemotherapy. Mary Lynne Hedley, president and chief operating officer of Tesaro, said that 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.”

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