|Astrazeneca plc, of Cambridge, U.K., and Merck & Co. Ltd., of Kenilworth, N.J.||Lynparza (olaparib)||PARP inhibitor||Epithelial ovarian, fallopian tube or primary peritoneal cancer||Approved by China’s NMPA for use as first-line maintenance treatment in adults with newly diagnosed advanced germline or somatic BRCA-mutated disease who are in complete or partial response to first-line platinum chemotherapy|
|Dcprime BV, of Leiden, the Netherlands||CDP-001||Cell-based vaccine||Acute myeloid leukemia||FDA granted orphan designation|
|Invivoscribe Inc., of San Diego||Leukostrat CDx FLT3 mutation assay||Companion diagnostic for Xospata||Relapsed or refractory FLT3mut+ acute myeloid leukemia||European Commission approved use as validated test for assessing AML patients for treatment with FLT3 inhibitor Xospata (gilteritinib, Astellas Inc.)|
|Meissa Vaccines Inc., of South San Francisco||MV-012-968||Vaccine||Respiratory syncytial virus||FDA accepted the IND for a phase I trial set to start in early 2020 to assess tolerability and immunogenicity in adults|
|Sesen Bio Inc., of Cambridge, Mass.||Vicinium||Locally administered fusion protein targeting EpCAM antigens||High-risk non-muscle invasive bladder cancer||Completed type B pre-BLA meeting with FDA regarding CMC content; expects to initiate submission in December 2019|
|Viiv Healthcare Ltd., of London||Fostemsavir||Attachment inhibitor||HIV-1 infection||Submitted NDA to FDA seeking approval for use in combination with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are unable to form a suppressive regimen due to resistance, intolerance or safety considerations|
For more information about individual companies and/or products, see Cortellis.