Zepzelca® (lurbinectedin) in combination with atezolizumab approved as first-line maintenance therapy for extensive-stage small cell lung cancer in United Arab Emirates (UAE)

Stockholm, Sweden, November 28, 2025 – Immedica today announced that the Emirates Drug Establishment has granted approval for Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.

"This approval is an important milestone for people living with extensive-stage small cell lung cancer in the UAE. Access to new treatment options is essential in a disease where time is critical, and we are committed to improving the day-to-day life for patients and their families." – said Anders Edvell,  CEO, Immedica.

The approval is based on results from the Phase 3 IMforte trial, which showed that the lurbinectedin and atezolizumab combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to atezolizumab maintenance therapy alone. Following four cycles of induction therapy, from the point of randomization the median overall survival (OS) for the combination regimen was 13.2 months versus 10.6 months (stratified hazard ratio [HR]=0.73; 95% CI: 0.57–0.95; p=0.0174). From the point of randomization, median progression-free survival (PFS) by independent assessment was 5.4 months versus 2.1 months, respectively (stratified HR=0.54, 95% CI: 0.43–0.67; p<0.0001). Safety was consistent with the known safety profiles of both treatments. The results were presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting and simultaneously published in The Lancet.

Immedica has a strategic partnership with PharmaMar, where Immedica holds the distribution rights to Zepzelca in the Nordics, the UK & Ireland, Central Eastern Europe as well as in the Middle East and North Africa.

About Zepzelca® (lurbinectedin)
Zepzelca is a synthetic analog of the natural marine-based tetrahydroisoquinoline trabectedin. It acts as an alkylating agent that inhibits oncogenic transcription leading to tumor cell death and it modulates the tumor microenvironment.

On November 25, 2025, the Emirates Drug Establishment approved Zepzelca in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, as maintenance treatment for adults with ES-SCLC whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide.

On July 01, 2021, the United Arab Emirates Ministry of Health & Prevention issued a Product Marketing Authorization approval for Zepzelca monotherapy for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy.

About small cell lung cancer (SCLC)
SCLC is an aggressive form of lung cancer characterized by rapid growth, early metastasis, and limited therapeutic options. It accounts for about 10–15 % of all lung cancer cases and tends to present at an advanced stage, often requiring systemic therapy. Because of its aggressive nature and propensity for relapse, the prognosis remains poor.
 

About PharmaMar
PharmaMar is a biopharmaceutical company headquartered in Madrid, Spain, specializing in the discovery, development, and commercialization of anticancer therapies derived from marine biodiversity. The company focuses its R&D efforts on rare and difficult-to-treat cancers, leveraging a proprietary platform of marine-derived compounds and strong collaborations with academic and industry partners.

For more information, visit www.pharmamar.com

About Immedica
Immedica is a pharmaceutical company, headquartered in Stockholm, Sweden, focused on the commercialization of medicines for rare diseases and specialty care products. Immedica’s capabilities cover marketing and sales, compliance, pharmacovigilance, quality assurance, regulatory, medical affairs and market access, as well as a global distribution network serving patients in more than 50 countries. Immedica is fully dedicated to helping those living with diseases which have a large unmet medical need. Immedica’s therapeutic areas are within RARE metabolic, RARE hematology & oncology, RARE neurology and specialty care. Immedica was founded in 2018 and employs today around 150 people across Europe, the Middle East and the United States. Immedica is backed by the investment firms KKR and Impilo.

For more information visit www.immedica.com.

Immedica contact:
Linda Holmström
VP, Head of Communication
[email protected]