EMA, FDA restrict use of PD-1 pathway inhibitors for bladder cancer
medwireNews: The EMA and US FDA have issued statements limiting the use of pembrolizumab and atezolizumab as single agents in the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma.
Both agencies have modified the indications for pembrolizumab and atezolizumab such that the agents can now only be given to those patients who are ineligible for cisplatin-based chemotherapy or those with a certain level of programmed cell death ligand 1 (PD-L1) expression. For pembrolizumab, the cutoff is a combined positive score of at least 10 points and for atezolizumab, the cutoff is a PD-L1 expression level of at least 5%.
These restrictions do not apply to patients who have progressed during or after platinum-based chemotherapy.
The EMA and FDA announcements are based on early results from the KEYNOTE-361 and IMvigor130 trials of pembrolizumab and atezolizumab, respectively, showing poorer survival with the checkpoint inhibitors when given as monotherapy than with chemotherapy in participants who are treatment-naïve and whose tumors express low levels of PD-L1.
According to the statements, the trials are continuing but only patients with PD-L1-high tumors will be enrolled in the pembrolizumab or atezolizumab monotherapy arms.
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