Accord Healthcare's Hetronifly® Gains European Approval for Advanced Lung Cancer Treatment

Hetronifly®: A New Hope for Lung Cancer Patients

Accord Healthcare has officially announced that its monoclonal antibody, Hetronifly® (serplulimab), has gained marketing authorization from the European Commission (EC) for its application in treating Extensive-Stage Small Cell Lung Cancer (ES-SCLC). This monumental decision positions Hetronifly® as the first anti-PD-1 monoclonal antibody approved in Europe specifically for this challenging form of lung cancer, used in combination with carboplatin and etoposide.

Having already achieved regulatory approval in nations like China and various Southeast Asian countries, the introduction of Hetronifly® into Europe marks a significant milestone in oncology, addressing a dire need for effective therapies against small cell lung cancer, which represents a considerable portion of lung cancer cases associated with poor prognoses.

Accord’s commitment to providing innovative solutions in cancer treatment is further exemplified by the orphan medicinal product designation Hetronifly® received from the EC in December 2022. The renewal of this designation in early 2025 underscores the potential impact that this medication could have in managing small cell lung cancer patients, a group with limited treatment options due to the aggressive nature of the disease.

The European Society for Medical Oncology (ESMO) has assigned serplulimab a strong clinical benefit score of 4 out of 5 in its Magnitude of Clinical Benefit Scale (MCBS) evaluation for ES-SCLC, reinforcing its position in the oncology landscape as a key option for first-line treatment.

In a collaborative agreement with Intas Pharmaceuticals, Accord Healthcare grants Intas exclusive rights to develop and market serplulimab across more than 50 countries in Europe and India, effectively broadening the reach of this crucial therapy. Now authorized in all 27 EU member states alongside Norway, Iceland, and Liechtenstein, Hetronifly® is set to impact the treatment landscape of advanced lung cancer significantly.

Paul Tredwell, Executive Vice President of EMENA at Accord Healthcare, expressed enthusiasm about this development, stating, “At Accord, we are committed to transforming the lives of patients. This approval allows us to provide a much-needed new treatment option for patients suffering from advanced small cell lung cancer. It highlights our dedication to advancing our specialized business and promoting innovation in cancer care, an area where we have a rich tradition.”

Serplulimab serves as the first recombinant humanized anti-PD-1 monoclonal antibody approved for frontline therapy in small cell lung cancer and is already undergoing further evaluations, including a direct comparative trial with atezolizumab, a well-known anti-PD-L1 monoclonal antibody. Articles on four pivotal trials of serplulimab have appeared in esteemed publications like JAMA, Nature Medicine, Cancer Cell, and the British Journal of Cancer, underlining the breadth of peer-reviewed support for this therapeutic agent.

Understanding Lung Cancer

Lung cancer remains the most prevalent and deadly cancer globally. According to GLOBOCAN 2022, there were over 2.48 million new lung cancer cases, which accounts for 12.4% of all cancer diagnoses worldwide. Small cell lung cancer, constituting approximately 15-20% of all lung cancer cases, exhibits rapid progression and early metastasis, significantly impacting patient survival rates.

Among patients diagnosed with small cell lung cancer, roughly 30-40% are identified at an early stage, while the remainder presents with extensive disease. The prevalence of this condition in Europe ranges from 1 to 5 cases per 10,000 individuals, reaffirming the necessity for more advanced therapeutic options like Hetronifly®.

With the backing of regulatory bodies and medical societies, Hetronifly® promises not only to enhance treatment protocols for advanced lung cancer patients but shifts the paradigm toward a more hopeful future in oncology. Accord Healthcare remains steadfast in its journey to expand innovative therapies that make a tangible difference in patient care across Europe and beyond.