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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.

The trastuzumab biosimilar Ogivri (MYL-1401O; trastuzumab-dkst) has been launched in the United States for all indications of the reference product, including the treatment of patients with HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma.

The UK’s National Institute for Health and Care Excellence has approved olaparib for the maintenance treatment of adult patients with relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease responded to platinum-based chemotherapy and harbor BRCA1/2 mutations.

The UK National Institute for Health and Care Excellence has approved palbociclib in combination with fulvestrant for the treatment of female patients with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer who have received prior endocrine therapy.