FDA approvals – Aug 2020

LinkedIn0Facebook0Tweet0 In August 2020, the FDA approved the following (3) products Liquid biopsy next-generation sequencing-based...
FDA_approvals
Magpie Concept Services

In August 2020, the FDA approved the following (3) products

Liquid biopsy next-generation sequencing-based FoundationOne Liquid CDx test for Foundation Medicine, Inc. This would help in identifying mutations in BRCA1 and BRCA2 genes in cell free-DNA isolated from plasma specimens from patients with metastatic castration-resistant prostate cancer (mCRPC) eligible for treatment with rucaparib (RUBRACA, Clovis Oncology, Inc.)

Carfilzomib (KYPROLIS, Onyx Pharmaceuticals, Inc.) and daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy

Belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline) for adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

Source: FDA

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