FDA approves Merck’s Keytruda in metastatic NSCLC

Approval is for first-line treatment of patients whose tumours have high PD-L1 expression with no EGFR or ALK genomic tumour aberrations.

Immune-mediated adverse reactions occurred with Keytruda including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Based on the severity of the adverse reaction, Keytruda (pembrolizumab) should be withheld or discontinued and corticosteroids administered when appropriate. Keytruda can also cause severe or life-threatening infusion-related reactions. Monitor patients for signs and symptoms of infusion-related reactions and for Grade 3 or 4 reactions, stop infusion and permanently discontinue Keytruda.

“Keytruda improved survival, compared to traditional chemotherapy, in patients with NSCLC whose tumours express high levels of PD-L1,” said Roger M. Perlmutter, president, Merck Research Laboratories. “The approval of Keytruda for the first-line treatment of metastatic NSCLC has the potential to change the treatment landscape for these patients.”

“With this new indication, Keytruda can now be a first treatment option instead of chemotherapy for patients with metastatic NSCLC whose tumours express high levels of PD-L1,” said Roy S. Herbst, professor of medicine and chief of medical oncology, Yale Cancer Center and Smilow Cancer Hospital at Yale New Haven. “These data reaffirm the importance of testing for PD-L1 expression in NSCLC to identify those patients who are most likely to benefit from treatment with Keytruda.”