Company Product Description Indication Status
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

Notes

For more information about individual companies and/or products, see Cortellis.

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