> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Alert on Keytruda and Tecentriq Decreased Survival
- URL: https://www.fdaweb.com/fda-alert-on-keytruda-and-tecentriq-decreased-survival/
- Published: 2018-05-18T12:00:00.000Z
- Updated: 2026-09-15T00:06:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141478

FDA has issued a [safety alert](https://www.fda.gov/Drugs/DrugSafety/ucm608075.htm?ref=fdaweb.com) about decreased survival associated with the use of Merck’s Keytruda (pembrolizumab) and Genentech’s Tecentriq (atezolizumab) as single therapy (monotherapy) 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). “In two ongoing clinical trials (KEYNOTE-361 and IMVIGOR-130), the data monitoring committees’ (DMC) early reviews found patients in the monotherapy arms of both trials with PD-L1 low status had decreased survival compared to patients who received cisplatin- or carboplatin-based chemotherapy,” the alert says. There was no change in the adverse event profile of both drugs. The companies have stopped enrolling patients whose tumors have PD-L1 low status to the Keytruda or Tecentriq monotherapy arms as recommended by the DMC. The clinical trials are comparing platinum-based chemotherapy combined with Keytruda or Tecentriq to platinum-based chemotherapy alone.

Both Keytruda and Tecentriq are currently approved under accelerated approval for treating locally advanced or metastatic urothelial carcinoma patients who are not eligible for cisplatin-containing chemotherapy, irrespective of PD-L1 status. Patients taking Keytruda or Tecentriq for other approved uses should continue to take their medication, the alert says.