FDA News Briefs for Monday, April 9, 2018April 9, 2018
These Food and Drug Administration (FDA) developments came in late last week:
Expanded approval for Rubraca
The FDA has approved Rubraca (rucaparib; Clovis Oncology, Inc.) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Biomarker testing is not required for patients to be prescribed Rubraca in this maintenance treatment indication. Rubraca was previously approved for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. More Information.
De Novo Clearance for Novel Rapid Infectious Disease Testing System
The FDA has granted a De Novo marketing clearance for the Unyvero System and Lower Respiratory Tract Infection (LRT) Application Cartridge (Curetis N.V.). The Unyvero System together with the Unyvero LRT Application Cartridge provides rapid infectious disease testing directly from aspirate samples in under 5 hours. It is the first automated molecular diagnostic test that is FDA-cleared for detection of Legionella pneumoniae. More Information.