FDA expands first-line NSCLC label for Merck & Co.'s Keytruda

The FDA on Thursday announced that the first-line indication for Merck & Co.'s Keytruda (pembrolizumab) in non-small-cell lung cancer (NSCLC) has been expanded. The agency noted that suitable patients must have tumours with no EGFR or ALK genomic aberrations and express PD-L1, with a tumour proportion score (TPS) of at least 1 percent, as determined by an FDA-approved test. 

Jonathan Cheng, vice president of oncology clinical research at Merck Research Laboratories, commented "this expanded first-line indication now makes Keytruda monotherapy an option for more patients with NSCLC, including those for whom combination therapy may not be appropriate." The immunotherapy was previously authorised in the US as a single agent for the first-line treatment of patients with metastatic NSCLC whose tumours express PD-L1 at a TPS of 50 percent or more. 

The FDA said approval of Keytruda for the expanded indication was bolstered by data from the Phase III KEYNOTE‑042 study of 1274 patients with stage III or IV NSCLC who had not received prior systemic treatment for metastatic NSCLC and whose tumours express PD-L1 at least at the 1-percent level. Results showed that in the overall study population, the anti-PD-1 treatment was associated with median overall survival of 16.7 months, versus 12.1 months for chemotherapy. 

Keytruda was cleared in Japan in January for use in patients with PD-L1-positive, unresectable, advanced/recurrent NSCLC in the first line setting. The therapy was also recently approved in Europe in combination with chemotherapy for the first-line treatment of adults with metastatic squamous NSCLC.

Merck reported in February that sales of Keytruda in the fourth quarter of 2018 surged 66 percent to $2.2 billion. 

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