FDA Alerts Health Care Professionals and Oncology Clinical Investigators about an Efficacy Issue Identified in Clinical Trials

PUBLISHED: Jun 21, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals, Long Term Care, Medical Office, Pharmacy

The U.S. Food and Drug Administration (FDA) is restricting the use of Keytruda and Tecentriq for patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing therapy.

This results from decreased survival associated with the use of Keytruda (pembrolizumab) or Tecentriq (atezolizumab) 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 reflect the restricted indications. The restricted indications for patients with urothelial cancer not eligible for cisplatin-containing therapy 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 (CPS) ≥ 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), or
  • Are not eligible for any platinum-containing therapy regardless of level of tumor PD-L1 expression
  • The tests used in the trial to determine PD-L1 expression are listed in Section 14 of each label.
  • The FDA is reviewing the findings of ongoing analyses and will communicate new information regarding the PD-L1 assays and indications as it becomes available.

In patients already receiving Keytruda or Tecentriq who are responding to treatment and are cisplatin-ineligible, continuation of treatment could be considered, regardless of PD-L1 status. The FDA has not changed the indications of Keytruda and Tecentriq for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment.

Patients taking Keytruda or Tecentriq for other approved uses should continue to take their medication as directed by their health care professional.

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