All Oncology News

The FDA has approved the trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst), which now has has approved indications for HER2-positive patients with breast or metastatic gastric or gastroesophageal junction adenocarcinoma.

The FDA announced that it has approved the FoundationOne CDx assay. The Centers for Medicare & Medicaid Services issued a simultaneous announcement saying the next-generation sequencing-based in vitro diagnostic test will be covered by insurance.

The European Commission has approved niraparib as a maintenance therapy for women with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.