MSD has announced that the US Food and Drug Administration (FDA) has approved an expanded label for the company's anti-PD-1 immunotherapy Keytruda.
The extension is for the drug as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 with no EGFR or ALK genomic tumor aberrations.
The approval is based on results from the Phase III KEYNOTE-042 trial, in which overall survival was found to significantly improve.
The extension makes Keytruda monotherapy an option for more patients with non-small cell lung cancer, including those for whom combination therapy may not be appropriate.
“The KEYNOTE-042 trial demonstrated a survival benefit with KEYTRUDA monotherapy across histologies in certain patients with stage III or metastatic non-small cell lung cancer whose tumors expressed PD-L1 in at least 1% of tumour cells”, said Dr Gilberto Lopes, associate director for global oncology at the Sylvester Comprehensive Cancer Center at the University of Miami.
“As a practicing oncologist, having additional options available for patients is important in the rapidly evolving treatment landscape for lung cancer, which remains the leading cause of cancer death in the United States.”
Keytruda was recently approved by the European Commission with a new six-weekly dosing schedule at 400mg, as opposed to the previous schedule of 200mg every three weeks, across all monotherapy indications.
This decision gives both patients and oncologists more flexibility, due to less hospital visits which could help chemotherapy nurses and chemotherapy lead consultants by freeing up chair time and infusion suite capacity, and oncology pharmacy by freeing up capacity when infusions are made up in-house.