How are GSK improving outcomes for people with the most prevalent gynaecological cancer in the UK?
08 Apr 2024
Phase 3Drug ApprovalImmunotherapyClinical ResultAccelerated Approval
Clinicians in Scotland can now administer dostarlimab in conjunction with platinum-containing chemotherapy for adult patients diagnosed with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer, who are suitable candidates for systemic therapy.
With approximately 740 new endometrial cancer cases reported annually in Scotland, an estimated 240 of these cases progress to advanced or recurrent stages. Following the Scottish Medicines Consortium's (SMC) decision, around 50 patients each year could qualify for dostarlimab treatment.
Dr Alison Stillie, consultant clinical oncologist at the Edinburgh Cancer Centre, said: “The SMC’s approval of dostarlimab, in combination with chemotherapy for eligible endometrial cancer patients with dMMR/MSI-H primary advanced or recurrent disease, is welcome news. This will give selected patients across Scotland, who have been faced with limited treatment options, the potential to access this treatment in the first line setting.”
Most prevalant gynecological cancer
Endometrial cancer, the most prevalent gynecological cancer in the UK, exhibits rising incidence and mortality rates. Despite medical advancements, outcomes for advanced and recurrent cases remain grim.
He said: “For many years, there has been little advancement in endometrial cancer treatment, with clinicians having few options for their patients. At GSK, we aspire to improve outcomes for people living with cancer, particularly those with unmet needs. We are proud of our collaborative work with NHS Scotland and SMC stakeholders and are delighted by today’s news, which may provide eligible Scottish patients with the opportunity to access this treatment in the first-line setting.”
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Suitable candidates for systemic therapy
The SMC's decision aligns with recent guidance from the National Institute for Health and Care Excellence (NICE), offering access to dostarlimab for eligible patients in England, Wales, and Northern Ireland. Dostarlimab, licensed in the UK since 2022, is the first immunotherapy treatment approved for use within NHS Scotland for this patient population.
Endometrial cancer affects the inner lining of the uterus and ranks as the most common gynaecological cancer in developed nations, with approximately 420,000 new cases globally in 2022.
Dostarlimab is indicated for combination with platinum-containing chemotherapy for adult patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer who are suitable candidates for systemic therapy.
Platinum-based chemotherapy
Also, as a monotherapy for adult patients with dMMR/MSI-H recurrent or advanced endometrial cancer following prior platinum-based chemotherapy.
The approval granted by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain and the European Medicines Agency (EMA) in Northern Ireland was based on data from part 1 of the phase 3 Ruby study, which evaluated dostarlimab plus carboplatin-paclitaxel versus placebo plus carboplatin-paclitaxel in patients with primary advanced or recurrent endometrial cancer.
The safety profile of dostarlimab combined with carboplatin-paclitaxel in the Ruby phase 3 trial aligns with the known profiles of the individual agents. Adverse events were generally consistent with expectations, with fatigue, alopecia, and nausea being the most common.
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