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All Oncology News

The investigational gene therapy nadofaragene firadenovec demonstrated a 3-month complete response rate of 53% in patients with high-grade, Bacillus Calmette-Guérin–unresponsive, non-muscle invasive bladder cancer with carcinoma in-situ with or without concomitant high-grade Ta or T1 papillary disease, meeting the primary endpoint of a phase III trial.

The FDA has scheduled an Oncologic Drugs Advisory Committee hearing for December 17, 2019, to discuss a supplemental new drug application for olaparib tablets as a maintenance treatment of adult patients with deleterious or suspected deleterious BRCA-mutant metastatic pancreatic adenocarcinoma whose disease has not progressed on frontline platinum-based chemotherapy.

China’s National Medical Products Administration has granted marketing authorization for olaparib as a first-line maintenance treatment for adult patients with newly diagnosed advanced germline or somatic BRCA-mutated epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to frontline platinum-based chemotherapy.