Oncology

FDA grants priority review to Zejula Niraparib (Zejula) received a priority review by the U.S. FDA, in response to a supplemental New Drug Application (sNDA) submitted by Tesaro. The drug, acquired by GlaxoSmithKline along with the drugmaker Tesaro for USD 5.1 Million, has an action date of October 24, 2019. The sNDA submitted supports new treatments for the advanced ovarian, fallopian tube, or primary peritoneal cancer patients treated with 3 or more prior chemotherapy regimens and whose cancer is associated with either BRCA mutation or homologous recombination deficiency (HRD) and who have progressed more than 6 months after the last platinum-based chemotherapy...