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New combination therapy for advanced small cell lung cancer approved in Australia and Singapore
Tuesday, April 21, 2026
Independent biopharmaceutical company Specialised Therapeutics has secured approval for ZEPZELCA (lurbinectedin), in combination with atezolizumab, as a first-line maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) in Australia and Singapore. The approval follows a positive recommendation from the European Medicines Agency for use in Europe.
The combination therapy is approved for patients whose disease has not progressed after initial treatment with atezolizumab, carboplatin and etoposide. It will be used as a maintenance option to help manage this aggressive form of lung cancer.
Both approvals were granted under Project Orbis, a global initiative led by the US Food and Drug Administration to speed up access to cancer treatments. This marks the eighth successful approval secured by Specialised Therapeutics through the programme since 2021.
Lung cancer continues to place a heavy burden on healthcare systems in the region. In Australia, around 15,000 cases are diagnosed each year, with about 9,000 deaths. In Singapore, lung cancer is the third most common cancer, with 9,732 cases reported between 2019 and 2023. Small cell lung cancer accounts for around 10–15% of all lung cancer cases and is often diagnosed after it has spread, with a five-year survival rate of less than 7%.
The newly approved combination is expected to support better disease control and improve survival outcomes in patients with extensive-stage disease, where relapse rates remain high and treatment options are limited.
ZEPZELCA is being supplied across Australia, New Zealand, Singapore, Malaysia, Thailand and Vietnam by Specialised Therapeutics under an exclusive licence agreement with PharmaMar, a company focused on marine-based cancer treatments.
ZEPZELCA belongs to a class of medicines known as alkylating agents. These drugs work by damaging the DNA of cancer cells, helping to slow or stop tumour growth.
The approvals are based on results from the Phase 3 IMforte clinical trial, which included 660 previously untreated patients with ES-SCLC across 13 countries. A total of 483 patients who responded to initial treatment were then given either the combination of ZEPZELCA and atezolizumab or atezolizumab alone as maintenance therapy.
The study showed that the combination therapy improved both progression-free survival and overall survival compared with atezolizumab alone. Median progression-free survival increased from 2.1 months to 5.4 months, while median overall survival improved from 10.6 months to 13.2 months.
Higher rates of treatment-related side effects were observed in patients receiving the combination therapy compared with those on atezolizumab alone. However, the treatment was generally considered tolerable, with no new safety concerns identified. Common side effects included reduced blood cell counts, nausea and fatigue.
Source: prnewswire.com
