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.
Merck (MSD) has announced that the FDA has approved Keytruda (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression (tumour proportion score [TPS] of 50% or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations. With this new indication, Keytruda is now the only anti-PD-1 therapy to be approved in the first-line treatment setting for these patients. In addition, the FDA approved a labeling update to include data from KEYNOTE-010 in the second-line or greater treatment setting for patients with metastatic NSCLC whose tumours express PDL1 (TPS of one percent or more) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda. In metastatic NSCLC, Keytruda is approved for use at a fixed dose of 200 mg every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
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.”
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