Accord Healthcare Secures MHRA Approval for Innovative Lung Cancer Treatment Hetronifly®
Accord Healthcare Receives Approval for Hetronifly® by MHRA
Accord Healthcare Limited has made significant strides in cancer treatment as it announces the approval of its anti-PD-1 monoclonal antibody, Hetronifly® (generic name Serplulimab), by the Medicines and Healthcare Regulatory Agency (MHRA) in the United Kingdom. This groundbreaking therapy is designated for the first-line treatment of advanced small cell lung cancer (ES-SCLC), a condition characterized by its aggressive nature and limited treatment options.
Background of Hetronifly®
This approval marks a milestone for Accord Healthcare, as Serplulimab becomes the first and only anti-PD-1 monoclonal antibody available in the UK for treating advanced SCLC patients who have not received prior treatment. The drug has gained significant attention in the oncology community; in fact, the European Society for Medical Oncology (ESMO) awarded it a score of 4 out of 5 on its Magnitude of Clinical Benefit Scale (MCBS) for its potential therapeutic impact. Moreover, in December 2022, Serplulimab received an orphan drug designation from the European Commission, recognizing its potential to benefit patients with this rare cancer form.
Currently, Serplulimab is approved in close to 40 countries, including China, various European nations, India, and Southeast Asia, demonstrating its global reach and acceptance. This robust approval spread underscores the urgent medical need for effective strategies against SCLC, which constitutes about 15% of all lung cancer cases.
Significance of the Approval
Julian Beach, the interim CEO of Quality and Access at MHRA, stated, “As the first and only approved anti-PD-1 monoclonal antibody for small cell lung cancer in the UK, this drug represents a crucial new option for patients battling this aggressive cancer type, who currently face limited choices and poor prognoses.” The impact of this approval resonates deeply within the healthcare landscape, emphasizing not only the advancement in treatment options but also the dedication of companies like Accord and its parent company Intas Pharmaceuticals in addressing critical health challenges.
Paul Tredwell, the Executive Vice President for EMENA at Accord Healthcare, expressed satisfaction with this news. He mentioned, “At Accord, we are committed to supporting cancer patients. The MHRA's approval of Hetronifly® provides a new treatment avenue in the fight against advanced small cell lung cancer, one of the most aggressive forms of the disease. This milestone reflects our ongoing commitment to offering cutting-edge therapies for hard-to-treat illnesses.”
Clinical Developments and Future Prospects
The approval of Hetronifly® finds its basis in comprehensive clinical studies, particularly Phase 3 trials such as ASTRUM-005, which involved 585 patients across 128 trial centers globally. Results presented during the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting showcased a survival rate of 21.9% over four years, reinforcing the potential of Serplulimab when combined with chemotherapy.
This promising outcome highlights the growing realization in the medical community that new treatments can profoundly alter patient outcomes, particularly in a group historically limited in options.
Furthermore, the original development of Serplulimab was spearheaded by Henlius Biotech, which has since entered into a collaboration with Intas Pharmaceuticals, granting exclusive rights for development and commercialization in over 50 countries across Europe and India. This partnership seeks to continuously evolve and expand the reach of innovative therapies like Hetronifly®.
Conclusion
Against the backdrop of a global push for more effective cancer treatments, Accord Healthcare’s approval for Hetronifly® signifies a beacon of hope for patients diagnosed with advanced small cell lung cancer, a disease notorious for its high malignancy and poor prognosis. With ongoing efforts to enhance treatment regimes and the expansion of availability, Hetronifly® stands as a critical advancement in oncology, paving the way for improved patient outcomes and highlighting the importance of innovation in healthcare.
The global health community eagerly anticipates more data from ongoing trials and the potential for new discoveries that could alter the treatment landscape for SCLC and beyond.