NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive decision recommending approval for pembrolizumab (Merck's Keytruda) alone and in combination with chemotherapy for PD-L1 positive, advanced head and neck cancer patients.
The recommended approval is for the first-line use of pembrolizumab as monotherapy or in combination with platinum and 5-fluorouracil chemotherapy for metastatic or unresectable, recurrent head and neck squamous cell carcinoma. The drug is recommended in individuals whose tumors have a PD-L1 combined positive score of 1 or more. (Combined positive score is a calculation based on the number of PD-L1 staining tumor cells, lymphocytes, and macrophages relative to all viable tumor cells.)
CHMP made its decision based on the results of the Phase III KEYNOTE-048 study, in which patients with this biomarker profile, who received pembrolizumab alone or in combination with chemo, experienced an overall survival advantage compared to those in the standard treatment arm containing cetuximab (Merck's Erbitux) and carboplatin or cisplatin plus 5-FU.
This data was presented at the European Society of Medical Oncology's annual meeting last year. Also based on this study, the US Food and Drug Administration approved pembrolizumab for the same indication in June.
The European Commission will review CHMP's recommendation and is slated to issue a final decision regarding marketing authorization later this year.