Patients in the European Union with certain forms of lung cancer are closer to getting to access MSD’s immunotherapy Keytruda, after regulatory advisors backed expanding the drug’s list of indications.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommend approval of the drug to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 and who have received at least one prior chemotherapy regimen.
The decision was based on findings from two studies – KEYNOTE-010, a pivotal study assessing overall survival (OS) and KEYNOTE-001, which assessed overall response rates (ORR) – showing significant improvements in patients taking Keytruda (pembrolizumab).
“Today’s news marks an important step in our ongoing efforts to bring forward a personalised treatment approach to identify advanced lung cancer patients who are most likely to benefit from pembrolizumab,” said Deepak Khanna, senior vice president and regional president, Europe, MSD Oncology.
“The CHMP positive opinion 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.”
Keytruda, a humanised monoclonal antibody that blocks the interaction between PD-1 and its ligands to activate the immune system, has already been approved in the US for NSCLC; a final decision is expected from the European Commission in the third-quarter of 2016.
In Europe the drug is already on the market to treat advanced melanoma.
