CHMP recommends Loqtorzi (toripalimab)for the treatment of nasopharyngeal carcinoma and oesophageal squamous cell carcinoma.- TMC Pharma.
On 25 July 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommendng the granting of a marketing authorisation for the medicinal product Loqtorzi, intended for the treatment of nasopharyngeal carcinoma and oesophageal squamous cell carcinoma. The applicant for this medicinal product is TMC Pharma (EU) Limited.
Loqtorzi will be available as a 240 mg concentrate for solution for infusion. The active substance of Loqtorzi is toripalimab, an antineoplastic agent (ATC code: L01FF13). Toripalimab is a humanized IgG4 kappa monoclonal antibody that binds to programmed death receptor-1 (PD-1). It blocks the binding of programmed death ligand-1 (PD-L1) and PD-L2 to PD-1, thereby preventing the inhibition of immune responses via the PD-1 pathway, including anti-tumour immune responses.
The benefit of Loqtorzi is an improved progression-free survival (PFS) in patients with locally advanced nasopharyngeal carcinoma and advanced or metastatic oesophageal squamous cell carcinoma, as shown in two studies comparing Loqtorzi with standard of care. The most common side effects with Loqtorzi in combination with platinum containing chemotherapy are anaemia, leukopenia, neutropenia, thrombocytopenia, nausea, vomiting, decreased appetite, rash, fatigue, abnormal liver function test, hypothyroidism, constipation and neuropathy.
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