CStone Pharmaceuticals (CSPHF,2616.HK) announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a new indication for sugemalimab as a monotherapy. This approval covers adult patients with unresectable stage III non-small cell lung cancer (NSCLC) who have PD-L1 expression on at least 1% of tumor cells, no sensitizing EGFR mutations, or ALK/ROS1 genomic aberrations, and whose disease has not progressed following platinum-based chemoradiotherapy (CRT).
Both the European Commission (EC) and MHRA have approved sugemalimab for two indications. The first is in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC without sensitizing EGFR mutations or ALK, ROS1, or RET genomic tumor aberrations. The second is as monotherapy for adult patients with unresectable stage III NSCLC meeting the above criteria after CRT.
In China, the National Medical Products Administration (NMPA) has approved sugemalimab for five indications. These include: in combination with chemotherapy as first-line treatment for metastatic squamous and non-squamous NSCLC without EGFR or ALK genomic tumor aberrations; treatment of unresectable stage III NSCLC after CRT; treatment of relapsed or refractory extranodal NK/T-cell lymphoma; in combination with fluorouracil and platinum-based chemotherapy as first-line treatment for unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC); and in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with PD-L1 expression CPS =5.
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