29 June 2022 | Wednesday | News
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GlaxoSmithKline (GSK) Singapore today 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.
As a PARP inhibitor, Zejula works by stopping proteins in our body from repairing ovarian cancer cells, causing them to die - which then helps to control the cancer. [i]
Ovarian cancer is the fifth most common cancer among women in Singapore. Unfortunately, it is also considered the deadliest gynaecological cancer as it is often only detected at its advanced stages.[ii] At the same time, the recurrence rate for advanced ovarian cancer is as high as 80%[iii], meaning the time a woman may spend without her cancer progressing until the next recurrence decreases every time. These make ovarian cancer especially challenging to treat.
Until now, only patients with BRCA-mutant advanced or relapsed ovarian cancer were eligible to be treated with an existing PARP inhibitor as monotherapy in the first-line and recurrent maintenance setting. That only makes up about 25% of patients with advanced ovarian cancer in Singapore.[iv]
Priya Kudva Menon, Vice President and General Manager – GSK Singapore, said: "We are extremely proud to be able to make our oncology medicines available in Singapore. This is an important step towards treatment of ovarian cancer. With this, more patients can access PARP inhibitors as a treatment option to slow down progression of the disease. [v]"
In April 2020, the US Food and Drug Administration (FDA) approved Zejula Capsule in the United States for use in first-line maintenance treatment of advanced ovarian cancer. The US FDA had also approved Zejula for use in the maintenance treatment of recurrent ovarian cancer earlier in March 2017. The approvals were supported by data from the pivotal phase 3 PRIMA study (ENGOT-OV26/GOG-3012) and phase 3 NOVA study (ENGOT-OV16) that demonstrated a clinically meaningful progression-free survival benefit of Zejula in the first-line maintenance setting and second-line maintenance setting respectively, regardless of BRCA mutation or biomarker status. The PRIMA study enrolled patients with newly diagnosed advanced ovarian cancer who responded to first-line treatment with platinum-based chemotherapy, while the NOVA study enrolled patients with recurrent ovarian cancer who had received at least two courses of platinum-based chemotherapy and had a complete or partial response to the most recent course of platinum-based chemotherapy. Zejula's safety profile, as demonstrated by PRIMA results, was consistent with the previously observed clinical safety profile. Haematologic adverse reactions, including low blood cell counts (low red blood cells, low white blood cells, and low platelets) were the most commonly reported in patients receiving Zejula. [vi]
Dr Sheow Lei Lim, Senior Consultant Medical Oncologist at OncoCare Cancer Centre, said: "We are happy that Zejula is now a treatment option available to women diagnosed with ovarian cancer in Singapore. We hope that today's approval will inspire hope in many more patients in their fight against this disease. It is also a significant breakthrough in addressing the unmet needs in gynaecological cancer and we appreciate the scientific dedication of GSK to this cause."
Zejula is available for first-line ovarian cancer (PRIMA) in 44 countries and 2 Special Administrative Regions as of March 2022. In the US, 1 in 2 new patients receiving a PARP inhibitor is currently treated with Zejula. In the EU, more than 6,000 patients have received Zejula as of February 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.