The Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion and recommended for grant of marketing authorization for the medicinal product, Hetronifly in European markets. It is intended to be used for the treatment of extensive-stage small cell lung cancer.
Hetronifly is expected to become the first anti-PD-1 monoclonal antibody available in Europe for first-line treatment of ES-SCLC. It is developed by Henlius and has been granted orphan drug status designation by the U.S. Food and Drug Administration (FDA) and the European Commission for the treatment of Small Cell Lung Cancer.
It should be prescribed and supervised by experienced doctors. Hetronifly will be available as a 10-mg/mL concentrate for solution for infusion. The active substance of Hetronifly is serplulimab, an antineoplastic monoclonal antibody (ATC code: L01FF12). By blocking the binding of PD-1 to PD-L1 and PD-L2, serplulimab potentiates T-cell responses, including anti-tumour responses.
The benefits of Hetronifly in combination with carboplatin and etoposide have been shown in a study involving adults with ES-SCLC. It led to improved survival rate and progression free survival in comparison with patients receiving only carboplatin and etoposide. As far as the common side effects are concerned, these include but not limited to nausea, decreased appetite, alopecia, hyperthyroidism, neutropenia, thrombocytopenia etc.
The EMA has said that it would be reviewing the latest information to decide whether to maintain the status of Hetronifly as an orphan medicine. Also, the detailed recommendations for the use of this product will be described i the summary of product characteristics which will be published in the European public assessment report and will be made available in all official European Union language after getting marketing authorization by the European Commission.
The information shared in this blog is for educational purposes only. You should always consult with your healthcare provider for any medical needs.
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