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FDA Limits the Use of Tecentriq and Keytruda

Posted 03 July 2018 | By Zachary Brennan 

FDA Limits the Use of Tecentriq and Keytruda

The US Food and Drug Administration (FDA) announced Tuesday that it has limited the use of Roche’s Tecentriq (atezolizumab) and Merck’s Keytruda (pembrolizumab) for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy.

The move, which was made official on 19 June 2018, comes as FDA said there was “decreased survival associated with the use of Keytruda or Tecentriq as single therapy (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).”

The labels of both drugs have been revised to read as follows:

“KEYTRUDA is indicated 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 is indicated 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 (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥5% of the tumor area), as determined by an FDA-approved test, or
  • Are not eligible for any platinum-containing therapy regardless of PD-L1 status.”
Meanwhile, on Monday, FDA approved the Ventana PD-L1 (SP142) Assay from Ventana Medical Systems, Inc. for PD‑L1 expression in ≥ 5% IC in urothelial carcinoma tissue.

“The test should be used to select patients with locally advanced or metastatic urothelial carcinoma for treatment with atezolizumab (Tecentriq, Genentech Inc.). The FDA also updated the Prescribing Information for Tecentriq to require use of an FDA-approved test for patient selection,” the agency said.

FDA limits the use of Tecentriq and Keytruda for some urothelial cancer patients
 
 

Categories: Regulatory News

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