Revised SPC: Keytruda (pembrolizumab) powder for concentrate for solution for infusion

SPC now clarifies that no dose reductions of pembrolizumab are recommended, and it should be withheld or discontinued to manage adverse reactions according to specific detail in the SPC.

SPS commentary:

It also states that in patients with NSCLC whose tumours have high PD‑L1 expression, the risk of adverse reactions with combination therapy relative to pembrolizumab monotherapy should be considered and the benefit/risk ratio of the combined therapy evaluated on an individual basis


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