CHMP positive recommendation for Cejemly (sugemalimab) + chemotherapy for the first-line treatment of metastatic non-small cell lung cancer (NSCLC). -SFL Pharmaceuticals Deutschland GmbH.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cejemly, intended for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in combination with chemotherapy.
The applicant for this medicinal product is SFL Pharmaceuticals Deutschland GmbH.
Cejemly will be available as 600 mg concentrate for solution for infusion. The active substance of Cejemly is sugemalimab, an antineoplastic monoclonal antibody (L01FF11) that potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 ligands. In patients with metastatic NSCLC, the benefits of Cejemly in combination with chemotherapy are a clinically meaningful improvement in progression-free survival and overall survival compared with placebo combined with chemotherapy. The most common side effects of Cejemly are anaemia (77.5%), aspartate aminotransferase increase (34.0%), alanine aminotransferase increase (32.0%).
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