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News & Trends - Pharmaceuticals

GSK adopts novel therapy for advanced ovarian cancer from Takeda Australia

Health Industry Hub | March 27, 2020 |

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 (TGA) to treat women with recurrent ovarian cancer who have responded to platinum-based chemotherapy, regardless of BRCA mutation or biomarker status.

Andrew Weekes, Medical Director of GSK told Health Industry Hub “This is a critical step in bringing Zejula to Australia for the benefit of patients, some of whom have limited options. We are delighted with the news, which comes with the responsibility to move through the next steps with a sense of urgency.

“GSK has significant depth and breadth in our oncology pipeline. Today represents a key milestone in our ambition to bring new solutions for cancer patients to Australia.”

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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.

Ovarian cancer is the leading cause of death from gynaecologic cancers worldwide. Epithelial ovarian carcinoma accounts for approximately 90% of ovarian malignancies. Primary peritoneal cancer (PPC) and fallopian tube cancer (FTC) resemble epithelial ovarian carcinoma morphologically and clinically, and are often included within the ovarian epithelial cancer designation.

A number of phase III clinical trials are underway globally to further evaluate Zejula in ovarian cancer therapy:

  • A Phase III Comparison of Platinum-Based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-Based Therapy as First-Line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer
  • NIraparib and Quality Of LifE is a Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib.
  • A Study of ZL-2306 (Niraparib) as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer
  • Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) in Platinum-sensitive Relapsed Ovarian Cancer
  • Platinum-based Chemotherapy With Atezolizumab and Niraparib in Patients With Recurrent Ovarian Cancer (ANITA)

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