The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of HETRONIFLY® (serplulimab), developed by Henlius Biotech and Intas Pharmaceuticals, for the treatment of extensive-stage small cell lung cancer (ES-SCLC) in European markets. This decision marks a significant step toward providing a new treatment option for patients with this aggressive form of lung cancer.
Serplulimab is a recombinant humanized anti-PD-1 monoclonal antibody (mAb) injection and the first innovative monoclonal antibody developed by Henlius. It has already been granted orphan drug status by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for SCLC treatment.
Intas Pharmaceuticals, through its subsidiary Accord Healthcare Ltd (Accord), will commercialize serplulimab across more than 30 countries in Europe. Accord currently supplies approximately one in three injectable oncology medicines in Europe.
Clinical Trial Data and Efficacy
The CHMP's positive opinion is primarily based on the ASTRUM-005 study, a randomized, double-blind, placebo-controlled, international multi-center clinical trial. This trial evaluated the efficacy and safety of serplulimab in combination with chemotherapy compared to placebo plus chemotherapy as a first-line treatment for ES-SCLC.
Dr. Jason Zhu, Executive Director and CEO of Henlius, stated, "The positive opinion from CHMP signifies a major milestone in our efforts to accelerate the global reach of our products and further validates Henlius' patient-centred R&D approach and commitment to global strategy."
Paul Tredwell, Executive Vice President of EMENA at Accord, noted, "This not only strengthens our current partnership with Henlius but also means serplulimab is on track to become part of the treatment landscape for extensive stage small cell lung cancer patients who currently have limited options and face a poor prognosis."
Lung Cancer Statistics and Current Treatment Landscape
According to GLOBOCAN 2022, lung cancer is the most diagnosed and the leading cause of cancer mortality worldwide, with over 2.48 million new cases in 2022, representing 12.4% of all new cancer cases. Small cell lung cancer (SCLC) accounts for 15%-20% of all lung cancer cases and is characterized by early metastasis, rapid disease progression, and a poor prognosis.
If formally approved, serplulimab is expected to become the first anti-PD-1 monoclonal antibody available in Europe for the first-line treatment of ES-SCLC, offering a new therapeutic avenue for patients with this challenging disease.
