GSK Australia now holds the marketing authorisation for Zejula (niraparib) for ovarian cancer

GSK Australia now holds the marketing authorisation for Zejula (niraparib) for ovarian cancer, following an agreement reached with Takeda Australia. This transfer of marketing authorisation is an important first step in the process for GSK to make this medicine available to Australian patients.

Zejula (niraparib) is an oral poly-ADP ribose polymerase inhibitor, also known as a PARP inhibitor, currently approved by the Australian Therapeutic Goods Administration to treat women with recurrent ovarian cancer who have responded to platinum-based chemotherapy, regardless of BRCA mutation or biomarker status.

Globally, GSK acquired Zejula in January 2019, through the acquisition of Tesaro, an oncology-focused biopharmaceutical company. This acquisition significantly strengthened and accelerated GSK’s oncology pipeline, bringing extended scientific capabilities and expertise. In Australia, Takeda was the marketing authorisation holder for Zejula in ovarian cancer until this transferred to GSK earlier this month.

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GSK invested over $7 billion in research and development globally in 2018, focusing on science related to the immune system, human genetics and advanced technologies. We work closely with leading local researchers and clinicians to ensure that Australian patients can access the latest global innovations, as they happen. We are committed to clinical data transparency and making our study results public, regardless of whether they reflect positively or negatively on our products.