BioCentury
ARTICLE | Regulation

Zejula’s label expansion reaches an untapped ovarian cancer population

April 29, 2020 7:46 PM UTC
Updated on Apr 29, 2020 at 9:55 PM UTC

The label expansion for GlaxoSmithKline’s Zejula niraparib will allow the company to tap into a broad ovarian cancer patient population that hasn’t been touched by other PARP inhibitors. It also sends another signal to drugmakers that cancer is still a priority for FDA during the COVID-19 pandemic.

FDA approved an sNDA for Zejula for first-line maintenance treatment of platinum-sensitive ovarian cancer, expanding its label from the second-line ovarian cancer setting. The sNDA was reviewed under the Real-Time Oncology Review pilot program...

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