Up­dat­ed: A week af­ter GSK pulls one Ze­ju­la in­di­ca­tion, FDA sets ODAC meet­ing to re­view re­vis­ing la­bel fur­ther

The FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee will meet on Nov. 22 to dis­cuss whether to pull an in­di­ca­tion for GSK’s ovar­i­an can­cer drug Ze­ju­la, con­sid­er­ing the fi­nal over­all sur­vival da­ta from the piv­otal tri­al on which the ap­proval was based.

ODAC will hear an up­date (the FDA press re­lease at the time nev­er men­tions OS) on Ze­ju­la’s ap­proval for the main­te­nance treat­ment of adult pa­tients with re­cur­rent ep­ithe­lial ovar­i­an, fal­lop­i­an tube, or pri­ma­ry peri­toneal can­cer who are in a com­plete or par­tial re­sponse to plat­inum-based chemother­a­py.

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Life Sciences Senior Associate

General Catalyst

San Francisco, CA, USA