The European Medicines Agency gave marketing authorization to two cancer therapies in February.
Non–Small Cell Lung Cancer
The Committee for Medicinal Products for Human Use (CHMP) approved tislelizumab (Tizveni) for the treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC) in adults.
Tislelizumab is a humanized immunoglobulin (Ig)–G4 variant monoclonal antibody that aids the body's immune system to recognize and attack tumor cells through blockade of programmed cell death protein 1 (PD-1) binding to programmed death–ligand 1 (PD-L1) and PD-L2 ligands.
The CHMP said that three open-label randomized phase 3 trials comparing tislelizumab with chemotherapy had shown an improvement in overall survival and progression-free survival in patients with locally advanced or metastatic NSCLC. The most common side effects are anemia , fatigue, and increased aspartate aminotransferase.
Tislelizumab could be used either in monotherapy or in combination with chemotherapy, the EMA said. Tislelizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous NSCLC who have:
- Locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation
- Metastatic NSCLC
As a monotherapy, tislelizumab is indicated for the treatment of adult patients with locally advanced or metastatic NCSLC after prior platinum-based therapy.
It will be made available as a 100-mg concentrate for solution for infusion.
Merkel Cell Carcinoma
The CHMP said that it has also approved orphan medicine retifanlimab (Zynyz) for treating rare and aggressive Merkel cell carcinoma , a very rare skin cancer.
Retifanlimab is an antineoplastic agent that works by binding to PD-1 receptor, blocking its interaction with its ligands PD-L1 and PD-L2, and stimulating T-cell response in the tumor microenvironment.
Retifanlimab was granted a marketing authorization based on evidence showing a high percentage of patients who responded to treatment as well as a long-lasting response in many patients. It is indicated as a monotherapy for the first-line treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma that is not suitable for surgery or radiation therapy.
Retifanlimab will be available as a 500-mg concentrate for solution for infusion.