22 April 2026 | Wednesday | News
Independent biopharmaceutical company Specialised Therapeutics (ST) welcomes the approval of ZEPZELCA® (lurbinectedin), in combination with atezolizumab (Tecentriq®), as a new first-line maintenance treatment option for adult patients in Australia and Singapore, who have been diagnosed with extensive-stage small cell lung cancer (ES-SCLC), an aggressive form of lung cancer.[1],[2] This follows the recent decision by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) to issue a positive opinion recommending the approval of ZEPZELCA in Europe.[
In combination with atezolizumab, ZEPZELCA has been approved for use in Australia and Singapore as a maintenance treatment for extensive-stage small cell lung cancer (ES-SCLC) in adult patients whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.
Both approvals for ZEPZELCA in ES-SCLC were obtained under Project Orbis — an initiative of the United States Food and Drug Administration's (US FDA's) Oncology Center of Excellence. These ZEPZELCA approvals represent the eighth time ST has successfully navigated the Project Orbis process since 2021.
Lung cancer remains a significant health challenge in the region, with an estimated 15,000 diagnoses and 9,000 deaths from the disease each year in Australia.[7],[8] In Singapore, lung cancer is the third most common cancer, with 9,732 new cases diagnosed between 2019-2023. Small cell lung cancer (SCLC) is a highly aggressive cancer that has often already spread to other organs when first diagnosed. It accounts for approximately 10-15% of all lung cancer cases and has a low 5-year survival rate of under 7%.[6]
Professor Nick Pavlakis, Medical Oncologist from Royal North Shore Hospital in Sydney, acknowledged the approval of the new combination therapy as an important step in helping to improve outcomes for patients with ES-SCLC.
"Most patients with small cell lung cancer typically present with extensive-stage disease at diagnosis, meaning they are often faced with experiencing high rates of relapse or recurrence, limited treatment options and a poor prognosis," said Professor Pavlakis.
"While outcomes for patients have improved over the past five years with the addition of immunotherapy to chemotherapy, there continues to be a significant clinical need to improve on first-line therapies used to treat extensive-stage small cell lung cancer to prolong disease control and enhance survival. Today's announcement is welcome news for the medical and patient community."
ZEPZELCA is being made available in Australia, New Zealand, Singapore, Malaysia, Thailand and Vietnam by Specialised Therapeutics (ST), under exclusive license from European biopharmaceutical company PharmaMar, which has pioneered the development of marine-based oncology medicines.
ST Chief Executive Officer, Mr Carlo Montagner, said the approval of ZEPZELCA for ES-SCLC in the first-line setting would provide clinicians and patients with an important new therapeutic option for this difficult to treat cancer.
"We are delighted to have secured regulatory approvals for ZEPZELCA in combination with atezolizumab as a first-line maintenance therapy for adults diagnosed with ES-SCLC in Australia and Singapore," said Mr Montagner.
"Despite the improved efficacy of first-line therapies for ES-SCLC that have been available since 2019, survival outcomes remain suboptimal, with an estimated 40% of patients experiencing a relapse and requiring second-line treatment. The availability of additional first-line treatment options will enable eligible patients and their clinicians to find the therapy that is right for them, can help to improve their quality of life and importantly, give them more time to spend with their families and loved ones."
Chief Medical Officer for PharmaMar, Javier Jimenez, welcomed the regulatory approval for ZEPZELCA, saying: "We are very pleased that patients in Australia and Singapore can have access to this new therapy, as it marks an important milestone in the management of this disease, where a significant unmet medical need persists. Building on more than 40 years of commitment to research in diseases with limited treatment options, we will continue to collaborate with our partner in Australia to enable timely and equitable access to this new treatment."
ZEPZELCA belongs to a class of medicines known as alkylating agents, which work by damaging the DNA of cancer cells, helping to slow or stop their growth.[12] The regulatory approvals for ES-SCLC in Australia and Singapore were based on results from the Phase 3 IMforte clinical trial. The study enrolled 660 treatment-naïve patients with ES-SCLC across 13 countries in the induction phase. Following this, 483 patients who responded to induction treatment were randomised to receive either ZEPZELCA with atezolizumab (LU-AT) or atezolizumab monotherapy (AT) as first-line maintenance therapy.[13] The trial results supported the use of LU-AT as a new first-line maintenance treatment option over AT alone in patients with this aggressive cancer, with improvements recorded in both median progression free survival (PFS; 5.4 months vs. 2.1 months) and median overall survival (OS; 13.2 months vs.10.6 months).[13]
Significant variations in treatment-related adverse events (AEs) were noted in the two trial groups (83.5% in patients receiving LU-AT vs. 40% among patients receiving AT monotherapy).[13] Treatment with LU-AT was considered to be generally well tolerated, with no new or unexpected safety signals.[13] The most common adverse reactions (≥ 30%), including laboratory abnormalities, in patients who received ZEPZELCA with atezolizumab were decreased lymphocytes, decreased platelets, decreased haemoglobin, decreased leukocytes, decreased neutrophils, nausea, and fatigue/asthenia.
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