FDA releases Cubicin data

Monday's advisory committee meeting on an sNDA for Cubicin daptomycin from Cubist (CBST) will focus on the power of the company's clinical study to demonstrate efficacy and the development of resistance to the drug, according to FDA briefing documents released Friday. CBST is seeking to expand the drug's label to include treatment of bacteremia caused by Staphylococcus aureus, including in patients with suspected or proven infective endocarditis. The PDUFA date is March 24.

FDA raised concerns about the real-world relevance of an open-label Phase II study, which demonstrated non-inferiority of Cubicin to standard therapies. The briefing documents note the heterogeneity of the study population, the small number of patients with infective endocarditis, and a higher proportion of persisting or relapsing bacteremias among treatment failures in the Cubicin arm compared to patients who received standard therapy. FDA also will ask the Anti-Infective Drugs Advisory Committee about the implications of increases in minimum inhibitory concentrations (a measure of resistance) that were observed during or after treatment with the drug. ...