FDA updates I-O drug labels to bring more targeted approach

21 June 2018

The US Food and Drug Administration (FDA) has added restrictions to the labels of two immunotherapy drugs for locally advanced or metastatic urothelial cancer patients who are not eligible for cisplatin-containing therapy.

While this does not appear good news for Merck & Co (NYSE: MRK) and Roche (ROG: SIX), the manufacturers of Keytruda (pembrolizumab) and Tecentriq (atezolizumab), respectively, it could be interpreted as a small step towards precision medicine by making sure that targeted therapies reach the right patients.

The guidance stems from decreased survival associated with the use of the PD-1/PD-L1 inhibitors as monotherapy compared to platinum-based chemotherapy in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).

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