The monoclonal antibody Hetronifly® (serplulimab) has been approved by the European Commission (EC) for first-line treatment of cancer advanced small cell lung cancer (SCLC). This approval is a key step in the fight against this disease, as it offers patients a new therapeutic option.
First anti-PD-1 mAb approved in Europe for advanced stage SCLC
Hetronifly is the first anti-PD-1 monoclonal antibody approved in Europe for the treatment of advanced SCLC. This drug has been approved for use in combination with carboplatin and etoposide, two standard drugs for treating this type of cancer. According to Paul Tredwell, Executive Vice President EMENA at Accord Healthcare, this approval “allows us to offer a much-needed new treatment option for patients with advanced SCLC.”
In addition, serplulimab has already been granted orphan drug designation by the EC, which underlines its importance in the treatment of SCLC.
A promising treatment with international support
Developed by Henlius Biotech, Hetronifly is already approved in China and several Southeast Asian countries. In 2023, Henlius established a collaboration with Intas Pharmaceuticals, which grants this company exclusive rights to market the drug in more than 50 countries in Europe and India. Accord Healthcare will be responsible for the commercialization of Hetronifly® in the countries of the European Union.
The European Society for Medical Oncology (ESMO) has awarded serplulimab a score of 4 out of 5 on its scale of clinical benefit magnitude for advanced-stage SCLC. This assessment reinforces confidence in the treatment's effectiveness.
The context of lung cancer and its global impact
Lung cancer accounts for 2.48 million new cases diagnosed annually, according to GLOBOCAN 2022 data. SCLC accounts for between 151 and 201% of all lung cancer cases. It is generally diagnosed at an advanced stage. The prognosis is generally poor, with a high rate of metastasis and rapid disease progression.
Among patients with SCLC, approximately 30% to 40% are diagnosed at limited stage, while the remainder are identified at an advanced stage. These patients, unfortunately, face a low survival rate due to the lack of effective treatment options.
Hetronifly® offers new hope for these patients by providing them with an innovative alternative in first-line treatment.
The approval of Hetronifly® by the European Commission opens up new possibilities in the treatment of advanced small cell lung cancer. This antibody has received great international support and has been successful in markets such as China and South-East Asia.
