FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

FDA Limits Use of Keytruda and Tecentriq

July 6, 2018
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The FDA limited the use of two cancer drugs Merck’s Keytruda (pembrolizumab) and Roche’s Tecentriq (atezolizumab) and updated their labeling to reflect the new limitations.

The agency decided to restrict the drugs because of decreased survival associated with their use as monotherapies compared to platinum-based chemotherapy in clinical trials to treat metastatic urothelial cancer patients who have not undergone prior therapy and who have low expression of the protein PD-L1.

Keytruda’s new indication says the drug is for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing therapy and whose tumors express PD-L1 (Combined Positive Score ≥ 10), or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

Tecentriq’s new indication is for treating  patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing therapy, and whose tumors express PD-L1 stained tumor-infiltrating immune cells covering ≥5% of the tumor area, or are not eligible for any platinum-containing therapy regardless of PD-L1 status.

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