Het European Medicines Agency (EMA) has recommended granting marketing authorization for the orphan medicine Hetronifly to treat extensive stage small cell lung cancer (ES-SCLC). Hetronifly contains serplulimab, a monoclonal antibody that blocks the binding of PD-1 to PD-L1 and PD-L2 to increase T-cell responses against tumors. When combined with chemotherapy, Hetronifly has been shown to improve overall survival and progression-free survival in patients with ES-SCLC. Common side effects include neutropenia, leukopenia, anemia, and nausea. The EMA will review additional information to decide on maintaining Hetronifly’s orphan medicine status, with a final decision by the European Commission on marketing authorization.
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