Singapore approves GSK’s new ovarian cancer therapy
GlaxoSmithKline (GSK) Singapore has announced that Health Sciences Authority has approved Zejula (niraparib) tablet, an oral, once-daily first-line and recurrent maintenance treatment for women with advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response following platinum-based chemotherapy. This new product registration makes Zejula the only poly (ADP-ribose) polymerase (PARP) inhibitor approved in Singapore for use as a monotherapy for patients with advanced and recurrent ovarian cancer, regardless of whether they have a BRCA mutation. Zejula is available for first-line ovarian cancer (PRIMA) in 44 countries and 2 Special Administrative Regions as of March 2022. Zejula is also being assessed across multiple tumour types and evaluated in combinations with several other therapeutics. Notably, it is currently being tested in a Phase III clinical trial, ZEST, exploring its further potential in treating patients with triple-negative breast cancer (TNBC) or BRCAm HER2- breast cancer, mutations which require specialised treatment.