The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending approval of MSD’s Keytruda (pembrolizumab) for the first-line treatment of patients with metastatic non-small-cell lung cancer (NSCLC).
Keytruda is an anti-programmed death-1 (PD-1) therapy that blocks the biological pathways cancers use to disguise themselves from the immune system.
The drug has been recommended for patients with NSCLC whose tumours have high PD-L1 expression with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) positive tumour mutations.
Patients with EGFR or ALK tumour mutations should also have received approved therapy for these mutations prior to receiving pembrolizumab.
MSD UK and Ireland managing director Louise Houson said: “Today’s news marks an important step in our ongoing efforts to bring forward a personalised treatment approach to identify metastatic lung cancer patients who are most likely to benefit from pembrolizumab.
“This second CHMP positive opinion for NSCLC along with last year’s EMA approval in advanced melanoma underscores our commitment to working closely with the European health authorities to expand access to pembrolizumab for those patients most in need.”
Data supporting the positive opinion was based on findings from KEYNOTE-024 that demonstrated better progression-free survival and overall survival with pembrolizumab.
The CHMP opinion for pembrolizumab will now be reviewed by the European Commission (EC) for central marketing authorisation in the European Union (EU).
Based on this CHMP recommendation, a final decision regarding the approval of single-agent pembrolizumab is expected from the EC in the first quarter of next year.
At present, Pembrolizumab is indicated in the EU for the treatment of locally advanced or metastatic NSCLC in adults.
Image: Micrograph of a squamous carcinoma, a type of non-small-cell lung carcinoma. Photo: courtesy of Nephron.