EMA Recommends Approval of Toripalimab for Nasopharyngeal and Oesophageal Cancers

On 25 July 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave a positive recommendation for the approval of toripalimab (brand name Loqtorzi). This medication is intended for the first-line treatment of patients with nasopharyngeal carcinoma and oesophageal squamous cell carcinoma.

1. About Toripalimab

Applicant: TMC Pharma (EU) Limited

Form: 240 mg concentrate for solution for infusion

Active Substance: Toripalimab (ATC code: L01FF13)

Mechanism: Toripalimab is a humanized monoclonal antibody that targets PD-1, a protein that, when activated, inhibits immune responses, including those against tumors. By blocking this pathway, toripalimab enhances the body's immune response against cancer cells.

2. Benefits and Side Effects

Efficacy

Clinical studies have shown that Loqtorzi improves progression-free survival in patients with locally advanced nasopharyngeal carcinoma and advanced or metastatic oesophageal squamous cell carcinoma compared to standard treatments.

Common Side Effects

Include anaemia, leukopenia, neutropenia, thrombocytopenia, nausea, vomiting, decreased appetite, rash, fatigue, abnormal liver function tests, hypothyroidism, constipation, and neuropathy.

3. Indications

Nasopharyngeal Carcinoma

Loqtorzi, in combination with cisplatin and gemcitabine, is recommended for adult patients with recurrent, non-operable or non-treatable by radiotherapy, or metastatic nasopharyngeal carcinoma.

Oesophageal Squamous Cell Carcinoma

Loqtorzi, combined with cisplatin and paclitaxel, is recommended for adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.

4. Prescribing Information

Loqtorzi should be prescribed and monitored by physicians experienced in cancer treatment. Detailed guidelines will be included in the summary of product characteristics, which will be published after the marketing authorisation is officially granted by the European Commission.

A summary of the positive opinion is available, though the final decision by the Commission is expected within 67 days of the CHMP’s recommendation.